AzTrials
AzTrials

HypoxemiaNCT05784636

Comparative Study on the Effectiveness, Comfort and Compliance of HFNC and Noninvasive Mechanical Ventilation BiPAP Mode in the Treatment of Hypoxemia Patients

A study testing Non-invasive BiPAP ventilation and HFNC in people with Hypoxemia, run by Qilu Hospital of Shandong University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Patients who met the inclusion criteria were included and signed an informed consent form, which complied with the requirements of the ethics committee of our unit. All subjects were inpatients. Subjects were randomized into two groups. Read more about this study

Who is it for?
Ages 20 to 80 years
Conditions the study is for
Hypoxemia
What is being tested?
Non-invasive BiPAP ventilation and HFNC
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
243 participants
Where
1 siteChina
Study dates
Mar 2023to 6 Jun 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • . PaO2 < 60mmHg, SpO2 < 92%(without oxygen inhalation);
  • Mild to moderate type I respiratory failure (100 mmHg < PaO/Fi02≤300 mmHg);

Who cannot join

  • Missing primary outcome measures
  • Terminal stage of various chronic diseases;
  • The patient or family members do not agree to NIV or HFNI treatment;
  • Severe type I respiratory failure (PaO2/Fi02≤100 mmHg)
  • Ventilation dysfunction (pH<7.30)
  • Contradictory breathing
  • The patient abandons or terminates treatment, automatically discharges or transfers to another hospital;
  • Serious diseases, such as organ function damage and sepsis;

Trial locations and contacts

1 site in 1 country.

Dedong Ma, MD contact

18560082806

ma@qiluhuxi.com

chunwei He, master contact

17361616499

hechw160814@163.com

China1 site

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250012

    Dedong Ma, MD, 18560082806, ma@qiluhuxi.com

    Chunwei He, MBBS, 17361616499, hechw160814@163.com

Other trials in China

About this study

Official title: Comparative Study on the Effectiveness, Comfort and Compliance of High-flow Nasal Oxygen Therapy and Noninvasive Mechanical Ventilation BiPAP Mode in the Treatment of Hypoxemia Patients

Patients who met the inclusion criteria were included and signed an informed consent form, which complied with the requirements of the ethics committee of our unit. All subjects were inpatients. Subjects were randomized into two groups. patients in group A were first treated with HFNC on top of conventional treatment, and after 24 hours, patients were treated with non-invasive ventilator-assisted ventilation BiPAP mode until discharge. patients in group B were treated with a non-invasive ventilator on top of conventional treatment, and after 24 hours of treatment, patients were treated with HFNC until discharge. Patient information was collected during treatment.

Read the detailed description

Patients who met the inclusion criteria were included and signed the informed consent, which met the requirements of the ethics committee of our unit. All subjects were hospitalized patients. Subjects were randomly divided into two groups. Patients in group A were treated with HFNC on the basis of conventional treatment. The initial parameters were: temperature:31-37℃, flow: 30-40l /min, SpO2 > 92% maintained, the oxygen concentration was adjusted according to the patient's oxygen saturation, and the treatment time was 24h. Twenty-four hours later, the patients were treated with non-invasive ventilator-assisted ventilation BiPAP mode until discharge. On the basis of conventional treatment, patients in group B were given a non-invasive ventilator with the following initial parameters: BiPaP mode, initial inspiratory pressure (IPAP) of 8-15cmH2O, initial expiratory pressure (EPAP) of 4-8cmH2O. The parameters were adjusted according to the specific conditions of the patients. After 24 hours of treatment, the patient was treated with HFNC until discharge. Patient information was collected during treatment.

Conditions
Hypoxemia
Being tested
Non-invasive BiPAP ventilation, HFNC
Keywords
Hypoxemia, High-flow nasal cannula, Mechanical ventilation
Medical subject headings
Hypoxia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Non-invasive BiPAP ventilationDevice

    Also called HFNC

    Patients were first treated with HFNC (High-flow nasal cannula) on the basis of conventional treatment. The initial parameters were temperature: 31-37 °C, flow rate: 30-40l /min, maintaining SpO2>92%, adjusting oxygen concentration according to blood oxygen saturation, and treatment duration was 24 h. After 24 h, patients were treated with non-invasive ventilator-assisted ventilation BiPAP mode until discharge.

  • HFNCDevice

    Also called Non-invasive BiPAP ventilation

    On the basis of conventional treatment, patients were first administered a noninvasive ventilator with the following initial parameters. BiPAP mode with an initial inspiratory pressure (IPAP) of 8-15 cmH2O and an initial expiratory pressure (EPAP) of 4-8 cmH2O. These parameters were adjusted according to the patient's specific conditions. After 24 hours of treatment, patients received HFNC (High-flow nasal cannula) until discharge.

Study groups in NCT05784636
Study groupRoleWhat they receive
Non-invasive BiPAP ventilation treatment groupExperimentalPatients were first treated with HFNC on the basis of conventional treatment. The initial parameters were temperature: 31-37 °C, flow rate: 30-40 L/min, maintaining SpO2>92%, adjusting oxygen concentration according to blood oxygen saturation, and treatment duration was 24 h. After 24 h, patients were treated with non-invasive ventilator-assisted ventilation BiPAP mode until discharge
Receives: Device: Non-invasive BiPAP ventilation; Device: HFNC
HFNC treatment groupExperimentalOn the basis of conventional treatment, patients were first administered a noninvasive ventilator with the following initial parameters. BiPAP mode with an initial inspiratory pressure (IPAP) of 8-15 cmH2O and an initial expiratory pressure (EPAP) of 4-8 cmH2O. These parameters were adjusted according to the patient's specific conditions. After 24 hours of treatment, patients received HFNC until discharge.
Receives: Device: Non-invasive BiPAP ventilation; Device: HFNC

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HR

    Heart rate

    Measured: At the time of enrollment in the clinical study

  2. HR

    Heart rate

    Measured: On the first hour after enrollment

  3. HR

    Heart rate

    Measured: On the second hour after enrollment

  4. HR

    Heart rate

    Measured: On the 6th hour after enrollment

  5. HR

    Heart rate

    Measured: On the 12th hour after enrollment

  6. HR

    Heart rate

    Measured: On the 24th hour after enrollment

  7. HR

    Heart rate

    Measured: On the 25th hour after enrollment (On the first hour after crossover)

  8. HR

    Heart rate

    Measured: On the 26th hour after enrollment (On the second hour after crossover)

  9. HR

    Heart rate

    Measured: On the 30th hour after enrollment (On the 6th hour after crossover)

  10. HR

    Heart rate

    Measured: On the 36th hour after enrollment (On the 12th hour after crossover)

  11. HR

    Heart rate

    Measured: On the 48th hour after enrollment (On the 24th hour after crossover)

  12. HR

    Heart rate

    Measured: On the third day after enrollment (On the 48th hour after crossover)

  13. HR

    Heart rate

    Measured: On the 4th day after enrollment (On the third day after crossover)

  14. HR

    Heart rate

    Measured: On the 5th day after enrollment (On the 4th day after crossover)

  15. HR

    Heart rate

    Measured: On the 6th day after enrollment (On the 5th day after crossover)

  16. HR

    Heart rate

    Measured: On the 7th day after enrollment (On the 6th day after crossover)

  17. HR

    Heart rate

    Measured: On the 8th day after enrollment (On the 7th day after crossover)

  18. HR

    Heart rate

    Measured: On the 9th day after enrollment (On the 8th day after crossover)

  19. RR

    Respiratory rate

    Measured: At the time of enrollment in the clinical study

  20. RR

    Respiratory rate

    Measured: On the first hour after enrollment

  21. RR

    Respiratory rate

    Measured: On the second hour after enrollment

  22. RR

    Respiratory rate

    Measured: On the 6th hour after enrollment

  23. RR

    Respiratory rate

    Measured: On the 12th hour after enrollment

  24. RR

    Respiratory rate

    Measured: On the 24th hour after enrollment

  25. RR

    Respiratory rate

    Measured: On the 25th hour after enrollment (On the first hour after crossover)

  26. RR

    Respiratory rate

    Measured: On the 26th hour after enrollment (On the second hour after crossover)

  27. RR

    Respiratory rate

    Measured: On the 30th hour after enrollment (On the 6th hour after crossover)

  28. RR

    Respiratory rate

    Measured: On the 36th hour after enrollment (On the 12th hour after crossover)

  29. RR

    Respiratory rate

    Measured: On the 48th hour after enrollment (On the 24th hour after crossover)

  30. RR

    Respiratory rate

    Measured: On the third day after enrollment (On the 48th hour after crossover)

  31. RR

    Respiratory rate

    Measured: On the 4th day after enrollment (On the third day after crossover)

  32. RR

    Respiratory rate

    Measured: On the 5th day after enrollment (On the 4th day after crossover)

  33. RR

    Respiratory rate

    Measured: On the 6th day after enrollment (On the 5th day after crossover)

  34. RR

    Respiratory rate

    Measured: On the 7th day after enrollment (On the 6th day after crossover)

  35. RR

    Respiratory rate

    Measured: On the 8th day after enrollment (On the 7th day after crossover)

  36. RR

    Respiratory rate

    Measured: On the 9th day after enrollment (On the 8th day after crossover)

  37. BP

    Blood pressure (Includes systolic and diastolic blood pressure)

    Measured: At the time of enrollment in the clinical study

  38. BP

    Blood pressure (Includes systolic and diastolic blood pressure)

    Measured: On the first hour after enrollment

  39. BP

    Blood pressure (Includes systolic and diastolic blood pressure)

    Measured: On the second hour after enrollment

  40. BP

    Blood pressure (Includes systolic and diastolic blood pressure)

    Measured: On the 6th hour after enrollment

  41. BP

    Blood pressure (Includes systolic and diastolic blood pressure)

    Measured: On the 12th hour after enrollment

  42. BP

    Blood pressure (Includes systolic and diastolic blood pressure)

    Measured: On the 24th hour after enrollment

  43. BP

    Blood pressure (Includes systolic and diastolic blood pressure)

    Measured: On the 25th hour after enrollment (On the first hour after crossover)

  44. BP

    Blood pressure (Includes systolic and diastolic blood pressure)

    Measured: On the 26th hour after enrollment (On the second hour after crossover)

  45. BP

    Blood pressure (Includes systolic and diastolic blood pressure)

    Measured: On the 30th hour after enrollment (On the 6th hour after crossover)

  46. BP

    Blood pressure (Includes systolic and diastolic blood pressure)

    Measured: On the 36th hour after enrollment (On the 12th hour after crossover)

  47. BP

    Blood pressure (Includes systolic and diastolic blood pressure)

    Measured: On the 48th hour after enrollment (On the 24th hour after crossover)

  48. BP

    Blood pressure (Includes systolic and diastolic blood pressure)

    Measured: On the third day after enrollment (On the 48th hour after crossover)

  49. BP

    Blood pressure (Includes systolic and diastolic blood pressure)

    Measured: On the 4th day after enrollment (On the third day after crossover)

  50. BP

    Blood pressure (Includes systolic and diastolic blood pressure)

    Measured: On the 5th day after enrollment (On the 4th day after crossover)

  51. BP

    Blood pressure (Includes systolic and diastolic blood pressure)

    Measured: On the 6th day after enrollment (On the 5th day after crossover)

  52. BP

    Blood pressure (Includes systolic and diastolic blood pressure)

    Measured: On the 7th day after enrollment (On the 6th day after crossover)

  53. BP

    Blood pressure (Includes systolic and diastolic blood pressure)

    Measured: On the 8th day after enrollment (On the 7th day after crossover)

  54. BP

    Blood pressure (Includes systolic and diastolic blood pressure)

    Measured: On the 9th day after enrollment (On the 8th day after crossover)

  55. SO2

    Pulse oxygen saturation

    Measured: At the time of enrollment in the clinical study

  56. SO2

    Pulse oxygen saturation

    Measured: On the first hour after enrollment

  57. SO2

    Pulse oxygen saturation

    Measured: On the second hour after enrollment

  58. SO2

    Pulse oxygen saturation

    Measured: On the 6th hour after enrollment

  59. SO2

    Pulse oxygen saturation

    Measured: On the 12th hour after enrollment

  60. SO2

    Pulse oxygen saturation

    Measured: On the 24th hour after enrollment

  61. SO2

    Pulse oxygen saturation

    Measured: On the 25th hour after enrollment (On the first hour after crossover)

  62. SO2

    Pulse oxygen saturation

    Measured: On the 26th hour after enrollment (On the second hour after crossover)

  63. SO2

    Pulse oxygen saturation

    Measured: On the 30th hour after enrollment (On the 6th hour after crossover)

  64. SO2

    Pulse oxygen saturation

    Measured: On the 36th hour after enrollment (On the 12th hour after crossover)

  65. SO2

    Pulse oxygen saturation

    Measured: On the 48th hour after enrollment (On the 24th hour after crossover)

  66. SO2

    Pulse oxygen saturation

    Measured: On the third day after enrollment (On the 48th hour after crossover)

  67. SO2

    Pulse oxygen saturation

    Measured: On the 4th day after enrollment (On the third day after crossover)

  68. SO2

    Pulse oxygen saturation

    Measured: On the 5th day after enrollment (On the 4th day after crossover)

  69. SO2

    Pulse oxygen saturation

    Measured: On the 6th day after enrollment (On the 5th day after crossover)

  70. SO2

    Pulse oxygen saturation

    Measured: On the 7th day after enrollment (On the 6th day after crossover)

  71. SO2

    Pulse oxygen saturation

    Measured: On the 8th day after enrollment (On the 7th day after crossover)

  72. SO2

    Pulse oxygen saturation

    Measured: On the 9th day after enrollment (On the 8th day after crossover)

  73. pH

    Degree of pH in arterial blood

    Measured: At the time of enrollment in the clinical study

  74. pH

    Degree of pH in arterial blood

    Measured: On the 24th hour after enrollment

  75. pH

    Degree of pH in arterial blood

    Measured: On the 48th hour after enrollment (On the 24th hour after crossover)

  76. pH

    Degree of pH in arterial blood

    Measured: On the third day after enrollment (On the 48th hour after crossover)

  77. pH

    Degree of pH in arterial blood

    Measured: On the 4th day after enrollment (On the 3th day after crossover)

  78. pH

    Degree of pH in arterial blood

    Measured: On the 5th day after enrollment (On the 4th day after crossover)

  79. pH

    Degree of pH in arterial blood

    Measured: On the 6th day after enrollment (On the 5th day after crossover)

  80. pH

    Degree of pH in arterial blood

    Measured: On the 7th day after enrollment (On the 6th day after crossover)

  81. pH

    Degree of pH in arterial blood

    Measured: On the 8th day after enrollment (On the 7th day after crossover)

  82. pH

    Degree of pH in arterial blood

    Measured: On the 9th day after enrollment (On the 8th day after crossover)

  83. PaO2

    Partial arterial oxygen pressure

    Measured: At the time of enrollment in the clinical study

  84. PaO2

    Partial arterial oxygen pressure

    Measured: On the 24th hour after enrollment

  85. PaO2

    Partial arterial oxygen pressure

    Measured: On the 48th hour after enrollment (On the 24th hour after crossover)

  86. PaO2

    Partial arterial oxygen pressure

    Measured: On the third day after enrollment (On the 48th hour after crossover)

  87. PaO2

    Partial arterial oxygen pressure

    Measured: On the 4th day after enrollment (On the 3th day after crossover)

  88. PaO2

    Partial arterial oxygen pressure

    Measured: On the 5th day after enrollment (On the 4th day after crossover)

  89. PaO2

    Partial arterial oxygen pressure

    Measured: On the 6th day after enrollment (On the 5th day after crossover)

  90. PaO2

    Partial arterial oxygen pressure

    Measured: On the 7th day after enrollment (On the 6th day after crossover)

  91. PaO2

    Partial arterial oxygen pressure

    Measured: On the 8th day after enrollment (On the 7th day after crossover)

  92. PaO2

    Partial arterial oxygen pressure

    Measured: On the 9th day after enrollment (On the 8th day after crossover)

  93. SaO2

    Arterial oxygen saturation

    Measured: At the time of enrollment in the clinical study

  94. SaO2

    Arterial oxygen saturation

    Measured: On the 24th hour after enrollment

  95. SaO2

    Arterial oxygen saturation

    Measured: On the 48th hour after enrollment (On the 24th hour after crossover)

  96. SaO2

    Arterial oxygen saturation

    Measured: On the third day after enrollment (On the 48th hour after crossover)

  97. SaO2

    Arterial oxygen saturation

    Measured: On the 4th day after enrollment (On the third day after crossover)

  98. SaO2

    Arterial oxygen saturation

    Measured: On the 5th day after enrollment (On the 4th day after crossover)

  99. SaO2

    Arterial oxygen saturation

    Measured: On the 6th day after enrollment (On the 5th day after crossover)

  100. SaO2

    Arterial oxygen saturation

    Measured: On the 7th day after enrollment (On the 6th day after crossover)

  101. SaO2

    Arterial oxygen saturation

    Measured: On the 8th day after enrollment (On the 7th day after crossover)

  102. SaO2

    Arterial oxygen saturation

    Measured: On the 9th day after enrollment (On the 8th day after crossover)

  103. PCO2

    partial pressure of carbon dioxide in arterial blood

    Measured: At the time of enrollment in the clinical study

  104. PCO2

    partial pressure of carbon dioxide in arterial blood

    Measured: On the 24th hour after enrollment

  105. PCO2

    partial pressure of carbon dioxide in arterial blood

    Measured: On the 48th hour after enrollment (On the 24th hour after crossover)

  106. PCO2

    partial pressure of carbon dioxide in arterial blood

    Measured: On the third day after enrollment (On the 48th hour after crossover)

  107. PCO2

    partial pressure of carbon dioxide in arterial blood

    Measured: On the 4th day after enrollment (On the third day after crossover)

  108. PCO2

    partial pressure of carbon dioxide in arterial blood

    Measured: On the 5th day after enrollment (On the 4th day after crossover)

  109. PCO2

    partial pressure of carbon dioxide in arterial blood

    Measured: On the 6th day after enrollment (On the 5th day after crossover)

  110. PCO2

    partial pressure of carbon dioxide in arterial blood

    Measured: On the 7th day after enrollment (On the 6th day after crossover)

  111. PCO2

    partial pressure of carbon dioxide in arterial blood

    Measured: On the 8th day after enrollment (On the 7th day after crossover)

  112. PCO2

    partial pressure of carbon dioxide in arterial blood

    Measured: On the 9th day after enrollment (On the 8th day after crossover)

  113. FiO2

    Fraction of inspiration O2

    Measured: At the time of enrollment in the clinical study

  114. FiO2

    Fraction of inspiration O2

    Measured: On the 24th hour after enrollment

  115. FiO2

    Fraction of inspiration O2

    Measured: On the 48th hour after enrollment (On the 24th hour after crossover)

  116. FiO2

    Fraction of inspiration O2

    Measured: On the third day after enrollment (On the 48th hour after crossover)

  117. FiO2

    Fraction of inspiration O2

    Measured: On the 4th day after enrollment (On the third day after crossover)

  118. FiO2

    Fraction of inspiration O2

    Measured: On the 5th day after enrollment (On the 4th day after crossover)

  119. FiO2

    Fraction of inspiration O2

    Measured: On the 6th day after enrollment (On the 5th day after crossover)

  120. FiO2

    Fraction of inspiration O2

    Measured: On the 7th day after enrollment (On the 6th day after crossover)

  121. FiO2

    Fraction of inspiration O2

    Measured: On the 8th day after enrollment (On the 7th day after crossover)

  122. FiO2

    Fraction of inspiration O2

    Measured: On the 9th day after enrollment (On the 8th day after crossover)

  123. Lac

    Lactic acid in arterial blood

    Measured: At the time of enrollment in the clinical study

  124. Lac

    Lactic acid in arterial blood

    Measured: On the 24th hour after enrollment

  125. Lac

    Lactic acid in arterial blood

    Measured: On the 48th hour after enrollment (On the 24th hour after crossover)

  126. Lac

    Lactic acid in arterial blood

    Measured: On the third day after enrollment (On the 48th hour after crossover)

  127. Lac

    Lactic acid in arterial blood

    Measured: On the 4th day after enrollment (On the third day after crossover)

  128. Lac

    Lactic acid in arterial blood

    Measured: On the 5th day after enrollment (On the 4th day after crossover)

  129. Lac

    Lactic acid in arterial blood

    Measured: On the 6th day after enrollment (On the 5th day after crossover)

  130. Lac

    Lactic acid in arterial blood

    Measured: On the 7th day after enrollment (On the 6th day after crossover)

  131. Lac

    Lactic acid in arterial blood

    Measured: On the 8th day after enrollment (On the 7th day after crossover)

  132. Lac

    Lactic acid in arterial blood

    Measured: On the 9th day after enrollment (On the 8th day after crossover)

  133. Glu

    Arterial blood glucose in arterial blood

    Measured: At the time of enrollment in the clinical study

  134. Glu

    Arterial blood glucose in arterial blood

    Measured: On the 24th hour after enrollment

  135. Glu

    Arterial blood glucose in arterial blood

    Measured: On the 48th hour after enrollment (On the 24th hour after crossover)

  136. Glu

    Arterial blood glucose in arterial blood

    Measured: On the third day after enrollment (On the 48th hour after crossover)

  137. GLu

    Arterial blood glucose in arterial blood

    Measured: On the 4th day after enrollment (On the third day after crossover)

  138. Glu

    Arterial blood glucose in arterial blood

    Measured: On the 5th day after enrollment (On the 4th day after crossover)

  139. Glu

    Arterial blood glucose in arterial blood

    Measured: On the 6th day after enrollment (On the 5th day after crossover)

  140. Glu

    Arterial blood glucose in arterial blood

    Measured: On the 7th day after enrollment (On the 6th day after crossover)

  141. Glu

    Arterial blood glucose in arterial blood

    Measured: On the 8th day after enrollment (On the 7th day after crossover)

  142. Glu

    Arterial blood glucose in arterial blood

    Measured: On the 9th day after enrollment (On the 8th day after crossover)

  143. A-aDO2

    The difference between the oxygen partial pressure of alveolar air and the oxygen partial pressure of arterial blood

    Measured: At the time of enrollment in the clinical study

  144. A-aDO2

    The difference between the oxygen partial pressure of alveolar air and the oxygen partial pressure of arterial blood

    Measured: On the 24th hour after enrollment

  145. A-aDO2

    The difference between the oxygen partial pressure of alveolar air and the oxygen partial pressure of arterial blood

    Measured: On the 48th hour after enrollment (On the 24th hour after crossover)

  146. A-aDO2

    The difference between the oxygen partial pressure of alveolar air and the oxygen partial pressure of arterial blood

    Measured: On the third day after enrollment (On the 48th hour after crossover)

  147. A-aDO2

    The difference between the oxygen partial pressure of alveolar air and the oxygen partial pressure of arterial blood

    Measured: On the 4th day after enrollment (On the third day after crossover)

  148. A-aDO2

    The difference between the oxygen partial pressure of alveolar air and the oxygen partial pressure of arterial blood

    Measured: On the 5th day after enrollment (On the 4th day after crossover)

  149. A-aDO2

    The difference between the oxygen partial pressure of alveolar air and the oxygen partial pressure of arterial blood

    Measured: On the 6th day after enrollment (On the 5th day after crossover)

  150. A-aDO2

    The difference between the oxygen partial pressure of alveolar air and the oxygen partial pressure of arterial blood

    Measured: On the 7th day after enrollment (On the 6th day after crossover)

  151. A-aDO2

    The difference between the oxygen partial pressure of alveolar air and the oxygen partial pressure of arterial blood

    Measured: On the 8th day after enrollment (On the 7th day after crossover)

  152. A-aDO2

    The difference between the oxygen partial pressure of alveolar air and the oxygen partial pressure of arterial blood

    Measured: On the 9th day after enrollment (On the 8th day after crossover)

  153. BE

    Base excess in arterial blood

    Measured: At the time of enrollment in the clinical study

  154. BE

    Base excess in arterial blood

    Measured: On the 24th hour after enrollment

  155. BE

    Base excess in arterial blood

    Measured: On the 48th hour after enrollment (On the 24th hour after crossover)

  156. BE

    Base excess in arterial blood

    Measured: On the third day after enrollment (On the 48th hour after crossover)

  157. BE

    Base excess in arterial blood

    Measured: On the 4th day after enrollment (On the third day after crossover)

  158. BE

    Base excess in arterial blood

    Measured: On the 5th day after enrollment (On the 4th day after crossover)

  159. BE

    Base excess in arterial blood

    Measured: On the 6th day after enrollment (On the 5th day after crossover)

  160. BE

    Base excess in arterial blood

    Measured: On the 7th day after enrollment (On the 6th day after crossover)

  161. BE

    Base excess in arterial blood

    Measured: On the 8th day after enrollment (On the 7th day after crossover)

  162. BE

    Base excess in arterial blood

    Measured: On the 9th day after enrollment (On the 8th day after crossover)

  163. RI

    Respiratory Index

    Measured: At the time of enrollment in the clinical study

  164. RI

    Respiratory Index

    Measured: On the 24th hour after enrollment

  165. RI

    Respiratory Index

    Measured: On the 48th hour after enrollment (On the 24th hour after crossover)

  166. RI

    Respiratory Index

    Measured: On the third day after enrollment (On the 48th hour after crossover)

  167. RI

    Respiratory Index

    Measured: On the 4th day after enrollment (On the third day after crossover)

  168. RI

    Respiratory Index

    Measured: On the 5th day after enrollment (On the 4th day after crossover)

  169. RI

    Respiratory Index

    Measured: On the 6th day after enrollment (On the 5th day after crossover)

  170. RI

    Respiratory Index

    Measured: On the 7th day after enrollment (On the 6th day after crossover)

  171. RI

    Respiratory Index

    Measured: On the 8th day after enrollment (On the 7th day after crossover)

  172. RI

    Respiratory Index

    Measured: On the 9th day after enrollment (On the 8th day after crossover)

  173. Arterial blood HCO3- concentration

    Arterial blood HCO3- concentration，including arterial blood HCO3- std concentration

    Measured: At the time of enrollment in the clinical study

  174. Arterial blood HCO3- concentration

    Arterial blood HCO3- concentration，including arterial blood HCO3- std concentration

    Measured: On the 24th hour after enrollment

  175. Arterial blood HCO3- concentration

    Arterial blood HCO3- concentration，including arterial blood HCO3- std concentration

    Measured: On the 48th hour after enrollment (On the 24th hour after crossover)

  176. Arterial blood HCO3- concentration

    Arterial blood HCO3- concentration，including arterial blood HCO3- std concentration

    Measured: On the third day after enrollment (On the 48th hour after crossover)

  177. Arterial blood HCO3- concentration

    Arterial blood HCO3- concentration，including arterial blood HCO3- std concentration

    Measured: On the 4th day after enrollment (On the third day after crossover)

  178. Arterial blood HCO3- concentration

    Arterial blood HCO3- concentration，including arterial blood HCO3- std concentration

    Measured: On the 5th day after enrollment (On the 4th day after crossover)

  179. Arterial blood HCO3- concentration

    Arterial blood HCO3- concentration，including arterial blood HCO3- std concentration

    Measured: On the 6th day after enrollment (On the 5th day after crossover)

  180. Arterial blood HCO3- concentration

    Arterial blood HCO3- concentration，including arterial blood HCO3- std concentration

    Measured: On the 7th day after enrollment (On the 6th day after crossover)

  181. Arterial blood HCO3- concentration

    Arterial blood HCO3- concentration，including arterial blood HCO3- std concentration

    Measured: On the 8th day after enrollment (On the 7th day after crossover)

  182. Arterial blood HCO3- concentration

    Arterial blood HCO3- concentration，including arterial blood HCO3- std concentration

    Measured: On the 9th day after enrollment (On the 8th day after crossover)

  183. Arterial blood K+ concentration

    Arterial blood K+ concentration

    Measured: At the time of enrollment in the clinical study

  184. Arterial blood K+ concentration

    Arterial blood K+ concentration

    Measured: On the 24th hour after enrollment

  185. Arterial blood K+ concentration

    Arterial blood K+ concentration

    Measured: On the 48th hour after enrollment (On the 24th hour after crossover)

  186. Arterial blood K+ concentration

    Arterial blood K+ concentration

    Measured: On the third day after enrollment (On the 48th hour after crossover)

  187. Arterial blood K+ concentration

    Arterial blood K+ concentration

    Measured: On the 4th day after enrollment (On the third day after crossover)

  188. Arterial blood K+ concentration

    Arterial blood K+ concentration

    Measured: On the 5th day after enrollment (On the 4th day after crossover)

  189. Arterial blood K+ concentration

    Arterial blood K+ concentration

    Measured: On the 6th day after enrollment (On the 5th day after crossover)

  190. Arterial blood K+ concentration

    Arterial blood K+ concentration

    Measured: On the 7th day after enrollment (On the 6th day after crossover)

  191. Arterial blood K+ concentration

    Arterial blood K+ concentration

    Measured: On the 8th day after enrollment (On the 7th day after crossover)

  192. Arterial blood K+ concentration

    Arterial blood K+ concentration

    Measured: On the 9th day after enrollment (On the 8th day after crossover)

  193. Arterial blood Ca2+ concentration

    Arterial blood Ca2+ concentration

    Measured: At the time of enrollment in the clinical study

  194. Arterial blood Ca2+ concentration

    Arterial blood Ca2+ concentration

    Measured: On the 24th hour after enrollment

  195. Arterial blood Ca2+ concentration

    Arterial blood Ca2+ concentration

    Measured: On the 48th hour after enrollment (On the 24th hour after crossover)

  196. Arterial blood Ca2+ concentration

    Arterial blood Ca2+ concentration

    Measured: On the third day after enrollment (On the 48th hour after crossover)

  197. Arterial blood Ca2+ concentration

    Arterial blood Ca2+ concentration

    Measured: On the 4th day after enrollment (On the third day after crossover)

  198. Arterial blood Ca2+ concentration

    Arterial blood Ca2+ concentration

    Measured: On the 5th day after enrollment (On the 4th day after crossover)

  199. Arterial blood Ca2+ concentration

    Arterial blood Ca2+ concentration

    Measured: On the 6th day after enrollment (On the 5th day after crossover)

  200. Arterial blood Ca2+ concentration

    Arterial blood Ca2+ concentration

    Measured: On the 7th day after enrollment (On the 6th day after crossover)

  201. Arterial blood Ca2+ concentration

    Arterial blood Ca2+ concentration

    Measured: On the 8th day after enrollment (On the 7th day after crossover)

  202. Arterial blood Ca2+ concentration

    Arterial blood Ca2+ concentration

    Measured: On the 9th day after enrollment (On the 8th day after crossover)

  203. Arterial blood Na+ concentration

    Arterial blood Na+ concentration

    Measured: At the time of enrollment in the clinical study

  204. Arterial blood Na+ concentration

    Arterial blood Na+ concentration

    Measured: On the 24th hour after enrollment

  205. Arterial blood Na+ concentration

    Arterial blood Na+ concentration

    Measured: On the 48th hour after enrollment (On the 24th hour after crossover)

  206. Arterial blood Na+ concentration

    Arterial blood Na+ concentration

    Measured: On the third day after enrollment (On the 48th hour after crossover)

  207. Arterial blood Na+ concentration

    Arterial blood Na+ concentration

    Measured: On the 4th day after enrollment (On the third day after crossover)

  208. Arterial blood Na+ concentration

    Arterial blood Na+ concentration

    Measured: On the 5th day after enrollment (On the 4th day after crossover)

  209. Arterial blood Na+ concentration

    Arterial blood Na+ concentration

    Measured: On the 6th day after enrollment (On the 5th day after crossover)

  210. Arterial blood Na+ concentration

    Arterial blood Na+ concentration

    Measured: On the 7th day after enrollment (On the 6th day after crossover)

  211. Arterial blood Na+ concentration

    Arterial blood Na+ concentration

    Measured: On the 8th day after enrollment (On the 7th day after crossover)

  212. Arterial blood Na+ concentration

    Arterial blood Na+ concentration

    Measured: On the 9th day after enrollment (On the 8th day after crossover)

  213. TCO2

    Total carbon dioxide in arterial blood

    Measured: At the time of enrollment in the clinical study

  214. TCO2

    Total carbon dioxide in arterial blood

    Measured: On the 24th hour after enrollment

  215. TCO2

    Total carbon dioxide in arterial blood

    Measured: On the 48th hour after enrollment (On the 24th hour after crossover)

  216. TCO2

    Total carbon dioxide in arterial blood

    Measured: On the third day after enrollment (On the 48th hour after crossover)

  217. TCO2

    Total carbon dioxide in arterial blood

    Measured: On the 4th day after enrollment (On the third day after crossover)

  218. TCO2

    Total carbon dioxide in arterial blood

    Measured: On the 5th day after enrollment (On the 4th day after crossover)

  219. TCO2

    Total carbon dioxide in arterial blood

    Measured: On the 6th day after enrollment (On the 5th day after crossover)

  220. TCO2

    Total carbon dioxide in arterial blood

    Measured: On the 7th day after enrollment (On the 6th day after crossover)

  221. TCO2

    Total carbon dioxide in arterial blood

    Measured: On the 8th day after enrollment (On the 7th day after crossover)

  222. TCO2

    Total carbon dioxide in arterial blood

    Measured: On the 9th day after enrollment (On the 8th day after crossover)

  223. HCT

    hematocrit in arterial blood

    Measured: At the time of enrollment in the clinical study

  224. HCT

    hematocrit in arterial blood

    Measured: On the 24th hour after enrollment

  225. HCT

    hematocrit in arterial blood

    Measured: On the 48th hour after enrollment (On the 24th hour after crossover)

  226. HCT

    hematocrit in arterial blood

    Measured: On the third day after enrollment (On the 48th hour after crossover)

  227. HCT

    hematocrit in arterial blood

    Measured: On the 4th day after enrollment (On the third day after crossover)

  228. HCT

    hematocrit in arterial blood

    Measured: On the 5th day after enrollment (On the 4th day after crossover)

  229. HCT

    hematocrit in arterial blood

    Measured: On the 6th day after enrollment (On the 5th day after crossover)

  230. HCT

    hematocrit in arterial blood

    Measured: On the 7th day after enrollment (On the 6th day after crossover)

  231. HCT

    hematocrit in arterial blood

    Measured: On the 8th day after enrollment (On the 7th day after crossover)

  232. HCT

    hematocrit in arterial blood

    Measured: On the 9th day after enrollment (On the 8th day after crossover)

  233. tHbc

    Total hemoglobin in arterial blood

    Measured: At the time of enrollment in the clinical study

  234. tHbc

    Total hemoglobin in arterial blood

    Measured: On the 24th hour after enrollment

  235. tHbc

    Total hemoglobin in arterial blood

    Measured: On the 48th hour after enrollment (On the 24th hour after crossover)

  236. tHbc

    Total hemoglobin in arterial blood

    Measured: On the third day after enrollment (On the 48th hour after crossover)

  237. tHbc

    Total hemoglobin in arterial blood

    Measured: On the 4th day after enrollment (On the third day after crossover)

  238. tHbc

    Total hemoglobin in arterial blood

    Measured: On the 5th day after enrollment (On the 4th day after crossover)

  239. tHbc

    Total hemoglobin in arterial blood

    Measured: On the 6th day after enrollment (On the 5th day after crossover)

  240. tHbc

    Total hemoglobin in arterial blood

    Measured: On the 7th day after enrollment (On the 6th day after crossover)

  241. tHbc

    Total hemoglobin in arterial blood

    Measured: On the 8th day after enrollment (On the 7th day after crossover)

  242. tHbc

    Total hemoglobin in arterial blood

    Measured: On the 9th day after enrollment (On the 8th day after crossover)

  243. height

    m

    Measured: At the time of enrollment in the clinical study

  244. Weight

    Kg

    Measured: At the time of enrollment in the clinical study

  245. gender

    Male and female

    Measured: At the time of enrollment in the clinical study

  246. age

    year

    Measured: At the time of enrollment in the clinical study

  247. WBC

    The number of white blood cells in venous blood

    Measured: On the first day after enrollment

  248. WBC

    The number of white blood cells in venous blood

    Measured: up to 9 days

  249. NEU

    The number of Neutrophil granulocyte in venous blood

    Measured: On the first day after enrollment

  250. NEU

    The number of Neutrophil granulocyte in venous blood

    Measured: up to 9 days

  251. LYM

    The number of Venous blood lymphocytes in venous blood

    Measured: On the first day after enrollment

  252. LYM

    The number of Venous blood lymphocytes in venous blood

    Measured: up to 9 days

  253. EOS

    The number of Venous blood eosinophils in venous blood

    Measured: On the first day after enrollment

  254. EOS

    The number of Venous blood eosinophils in venous blood

    Measured: up to 9 days

  255. BAS

    The number of Venous blood Basophils in venous blood

    Measured: On the first day after enrollment

  256. BAS

    The number of Venous blood Basophils in venous blood

    Measured: up to 9 days

  257. MON

    The number of Venous blood Monocyte cell in venous blood

    Measured: On the first day after enrollment

  258. MON

    The number of Venous blood Monocyte cell in venous blood

    Measured: up to 9 days

  259. RBC

    The number of red blood cells in venous blood

    Measured: On the first day after enrollment

  260. RBC

    The number of red blood cells in venous blood

    Measured: up to 9 days

  261. HGB

    The number of haemoglobin in venous blood

    Measured: On the first day after enrollment

  262. HGB

    The number of haemoglobin in venous blood

    Measured: up to 9 days

  263. HCT

    hematocrit in venous blood

    Measured: On the first day after enrollment

  264. HCT

    hematocrit in venous blood

    Measured: up to 9 days

  265. MCV

    Mean Corpuscular Volume in venous blood

    Measured: On the first day after enrollment

  266. MCV

    Mean Corpuscular Volume in venous blood

    Measured: up to 9 days

  267. MCH

    Mean Corpuscular Haemoglobin Concentration in venous blood

    Measured: On the first day after enrollment

  268. MCH

    Mean Corpuscular Haemoglobin Concentration in venous blood

    Measured: up to 9 days

  269. RDW

    red blood cell distribution width in venous blood

    Measured: On the first day after enrollment

  270. RDW

    red blood cell distribution width in venous blood

    Measured: up to 9 days

  271. PLT

    platelet in venous blood

    Measured: On the first day after enrollment

  272. PLT

    platelet in venous blood

    Measured: up to 9 days

  273. PDW

    Platelet distributionwidth in venous blood

    Measured: On the first day after enrollment

  274. PDW

    Platelet distributionwidth in venous blood

    Measured: up to 9 days

  275. MPV

    Mean Platelet Volume in venous blood

    Measured: On the first day after enrollment

  276. MPV

    Mean Platelet Volume in venous blood

    Measured: up to 9 days

  277. plateletcrit

    plateletcrit in venous blood

    Measured: On the first day after enrollment

  278. plateletcrit

    plateletcrit in venous blood

    Measured: up to 9 days

  279. CRP

    C-reactive protein in venous blood

    Measured: On the first day after enrollment

  280. CRP

    C-reactive protein in venous blood

    Measured: up to 9 days

  281. PCT

    Procalcitonin in venous blood

    Measured: On the first day after enrollment

  282. PCT

    Procalcitonin in venous blood

    Measured: up to 9 days

  283. NT-proBNP

    NT-proBNP in venous blood

    Measured: On the first day after enrollment

  284. NT-proBNP

    NT-proBNP in venous blood

    Measured: up to 9 days

  285. ESR

    erythrocytesedimentationrate in venous blood

    Measured: On the first day after enrollment

  286. ESR

    erythrocytesedimentationrate in venous blood

    Measured: up to 9 days

  287. PT

    prothrombin time in venous blood

    Measured: On the first day after enrollment

  288. PT

    prothrombin time in venous blood

    Measured: up to 9 days

  289. APTT

    activated partial thromboplastin time in venous blood

    Measured: On the first day after enrollment

  290. APTT

    activated partial thromboplastin time in venous blood

    Measured: up to 9 days

  291. TT

    Thrombin time in venous blood

    Measured: On the first day after enrollment

  292. TT

    Thrombin time in venous blood

    Measured: up to 9 days

  293. D-Di

    D-Dimer in venous blood

    Measured: On the first day after enrollment

  294. D-Di

    D-Dimer in venous blood

    Measured: up to 9 days

  295. ALT

    alanine transaminase in venous blood

    Measured: On the first day after enrollment

  296. ALT

    alanine transaminase in venous blood

    Measured: up to 9 days

  297. AST

    Aspartate Transaminase in venous blood

    Measured: On the first day after enrollment

  298. AST

    Aspartate Transaminase in venous blood

    Measured: up to 9 days

  299. PA

    Serum prealbumin in venous blood

    Measured: On the first day after enrollment

  300. PA

    Serum prealbumin in venous blood

    Measured: up to 9 days

  301. TP

    Total serum protein in venous blood

    Measured: On the first day after enrollment

  302. TP

    Total serum protein in venous blood

    Measured: up to 9 days

  303. ALB

    Albumin protein in venous blood

    Measured: On the first day after enrollment

  304. ALB

    Albumin protein in venous blood

    Measured: up to 9 days

  305. GLB

    Globulin globulin in venous blood

    Measured: On the first day after enrollment

  306. GLB

    Globulin globulin in venous blood

    Measured: up to 9 days

  307. Cr

    creatinine in venous blood

    Measured: On the first day after enrollment

  308. Cr

    creatinine in venous blood

    Measured: up to 9 days

  309. BUN

    Urea nitrogen in venous blood

    Measured: On the first day after enrollment

  310. BUN

    Urea nitrogen in venous blood

    Measured: up to 9 days

  311. Cys-C

    Cystatin C in venous blood

    Measured: On the first day after enrollment

  312. Cys-C

    Cystatin C in venous blood

    Measured: up to 9 days

  313. eGFR

    Estimate glomerular filtration rate in venous blood

    Measured: On the first day after enrollment

  314. eGFR

    Estimate glomerular filtration rate in venous blood

    Measured: up to 9 days

  315. Respiratory support time

    Daily respiratory support time after patients were enrolled in the clinical study，h/Day

    Measured: during hospitalization, approximately 9 days

  316. Relief time for dyspnea

    Remission time of dyspnea after intervention

    Measured: during hospitalization, approximately 9 days

  317. Tracheal intubation

    Yes or No

    Measured: during hospitalization, approximately 9 days

  318. Stay in the ICU

    Yes or No

    Measured: during hospitalization, approximately 9 days

  319. Complications

    Facial injury, flatulence，Gastroesophageal reflux，Dry throat, sore throat，pneumothorax，Eye irritation discomfort，Low blood pressure.

    Measured: during hospitalization, approximately 9 days

  320. Outcome of disease

    Get better, get worse, die

    Measured: during hospitalization, approximately 9 days

  321. Total bilirubin

    Serum total bilirubin in venous blood

    Measured: On the first day after enrollment

  322. Total bilirubin

    Serum total bilirubin in venous blood

    Measured: up to 9 days

  323. DBIL

    Direct bilirubin in venous blood

    Measured: On the first day after enrollment

  324. DBIL

    Direct bilirubin in venous blood

    Measured: up to 9 days

  325. IBIL

    Indirect bilirubin in venous blood

    Measured: On the first day after enrollment

  326. IBIL

    Indirect bilirubin in venous blood

    Measured: up to 9 days

  327. Diaphragm mobility

    The patient is lying in a flat position. The convex array probe is placed at the junction of the anterior axillary line, midclavicular line, and rib margin (bilaterally), with the probe mark facing outward and downward for measurement.

    Measured: At the time of enrollment in the clinical study

  328. Diaphragm mobility

    The patient is lying in a flat position. The convex array probe is placed at the junction of the anterior axillary line, midclavicular line, and rib margin (bilaterally), with the probe mark facing outward and downward for measurement.

    Measured: On the 24th hour after enrollment

  329. Diaphragm mobility

    The patient is lying in a flat position. The convex array probe is placed at the junction of the anterior axillary line, midclavicular line, and rib margin (bilaterally), with the probe mark facing outward and downward for measurement.

    Measured: On the 48th hour after enrollment (On the 24th hour after crossover)

  330. Diaphragm mobility

    The patient is lying in a flat position. The convex array probe is placed at the junction of the anterior axillary line, midclavicular line, and rib margin (bilaterally), with the probe mark facing outward and downward for measurement.

    Measured: up to 9 days

  331. Diaphragm thickness

    Includes end-inspiratory diaphragm thickness and end-expiratory diaphragm thickness；The patient is lying flat on the bed. A linear array probe is placed in the mid-axillary line or between the anterior and mid-axillary lines between the eighth and tenth ribs, and measurements are taken.

    Measured: At the time of enrollment in the clinical study

  332. Diaphragm thickness

    Includes end-inspiratory diaphragm thickness and end-expiratory diaphragm thickness；The patient is lying flat on the bed. A linear array probe is placed in the mid-axillary line or between the anterior and mid-axillary lines between the eighth and tenth ribs, and measurements are taken.

    Measured: On the 24th hour after enrollment

  333. Diaphragm thickness

    Includes end-inspiratory diaphragm thickness and end-expiratory diaphragm thickness；The patient is lying flat on the bed. A linear array probe is placed in the mid-axillary line or between the anterior and mid-axillary lines between the eighth and tenth ribs, and measurements are taken.

    Measured: On the 48th hour after enrollment (On the 24th hour after crossover)

  334. Diaphragm thickness

    Includes end-inspiratory diaphragm thickness and end-expiratory diaphragm thickness；The patient is lying flat on the bed. A linear array probe is placed in the mid-axillary line or between the anterior and mid-axillary lines between the eighth and tenth ribs, and measurements are taken.

    Measured: up to 9 days

Secondary outcomes (3)

  1. Patient compliance to the treatment

    Patients were managed for compliance with the treatment.Dependent judgment

    1. Complete dependence: patients actively cooperate with medical staff in treatment
    2. Partial dependence: in most cases, patients can cooperate with the treatment, and in a few cases, patients resist the treatment but receive treatment after being enlightened by the medical staff.
    3. Non-dependence: patients have strong resistance and resistance, so that they are unable to use ventilators or nasal high-flow humidification instruments.

    Measured: during hospitalization, approximately 9 days

  2. Kolcaba Comfort Scale (GCQ) assessment assesses patient comfort

    Kolcaba's General Comfort Questionnaire (GCQ) is composed of 28 items from 4 dimensions: physiological, psychological, spiritual, socio-cultural and environmental. The modification Scale adopts 1 to 4Likert Scale, with 1 indicating strongly disagree and 4 indicating strongly agree. In the negative question, 1 means strongly agree and 4 means strongly disagree. A higher score indicates more comfort.

    Measured: during hospitalization, approximately 9 days

  3. Dyspnea rating scale

    According to the degree of dyspnea and symptoms of the patient, the lowest score is 0, the highest score is 10.

    Measured: during hospitalization, approximately 9 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2023
  2. Study startMar 2023 (estimated)
  3. Primary completion1 Jun 2024 (estimated)
  4. Study completion6 Jun 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
243 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05784636
Sponsor's protocol ID
2022039
Status last verified
Nov 2022
First submitted
19 Sep 2022
Last updated
27 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Milesi C, Essouri S, Pouyau R, Liet JM, Afanetti M, Portefaix A, Baleine J, Durand S, Combes C, Douillard A, Cambonie G; Groupe Francophone de Reanimation et d'Urgences Pediatriques (GFRUP). High flow nasal cannula (HFNC) versus nasal continuous positive airway pressure (nCPAP) for the initial respiratory management of acute viral bronchiolitis in young infants: a multicenter randomized controlled trial (TRAMONTANE study). Intensive Care Med. 2017 Feb;43(2):209-216. doi: 10.1007/s00134-016-4617-8. Epub 2017 Jan 26.

    PubMed 28124736

  • Lewis SR, Baker PE, Parker R, Smith AF. High-flow nasal cannulae for respiratory support in adult intensive care patients. Cochrane Database Syst Rev. 2021 Mar 4;3(3):CD010172. doi: 10.1002/14651858.CD010172.pub3.

    PubMed 33661521

  • Chen BX, Ou Q, Pan MX. [A cross-sectional survey of treatment acceptance and influence factors in patients with obstructive sleep apnea]. Zhonghua Yi Xue Za Zhi. 2018 May 29;98(20):1578-1581. doi: 10.3760/cma.j.issn.0376-2491.2018.20.010. Chinese.

    PubMed 29886648

Questions about this trial

What is this clinical trial studying?

A study testing Non-invasive BiPAP ventilation and HFNC in people with Hypoxemia, run by Qilu Hospital of Shandong University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Dedong Ma, MD (18560082806, ma@qiluhuxi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HR (time frame: At the time of enrollment in the clinical study). The study lists 334 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05784636, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2023.

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