to Assess the Corresponding PEEP Values in NIV With CPAP Under Different Airflow Rates During HFOT in Heart Failure PatientsNCT06107907
Using Electrical Impedance Tomography to Investigate the Relationship Between Airflow Rate During High-flow Oxygen Therapy and Pressure in Patients With Heart Failure Compared to Non-invasive Ventilation
A study testing Non-invasive ventilation (NIV) or high-flow oxygen therapy (HFOT) using electrical impedance tomography (EIT) in people with to Assess the Corresponding PEEP Values in NIV With CPAP Under Different Airflow Rates During HFOT in Heart Failure Patients, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Non-invasive ventilation (NIV) has been widely used in heart failure patients with supporting evidence. However, the drawbacks and contraindications associated with NIV limit its applicability in certain patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- to Assess the Corresponding PEEP Values in NIV With CPAP Under Different Airflow Rates During HFOT in Heart Failure Patients
- What is being tested?
- Non-invasive ventilation (NIV) or high-flow oxygen therapy (HFOT) using electrical impedance tomography (EIT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Nov 2023to Mar 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients in the intensive care unit (ICU) with PaO2/FiO2 ≤ 300, requiring Non-Invasive Ventilation (NIV) and High-Flow Oxygen Therapy (HFOT) and stable use of NIV and HFOT for at least 24 hours will be eligible for enrollment.
- Evidence of pulmonary infiltrates on chest X-ray in patients with heart failure.
- Alert and able to follow instructions.
Who cannot join
- Age < 18 years.
- Patients with a history of tracheostomy.
- Hemodynamically unstable (defined as a mean arterial pressure persistently below 60 mmHg despite fluid resuscitation or vasopressor support).
- Severe chronic obstructive pulmonary disease (COPD).
- History of nasal trauma and/or nasal septal deviation or any other reason preventing the use of High-Flow Oxygen Therapy (HFOT).
- Presence of facial wounds or any other reason preventing the use of Non-Invasive Ventilation (NIV).
- Contraindications to Electrical Impedance Tomography (EIT) use (e.g., patients with implanted pacemakers) or inability to place EIT belt (e.g., due to wound dressings or chest drainage).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Shin Ming-Hann, MD, 0934-017031, x106731@ntuh.edu.tw
Kuo Yao-Wen, MD, 0972-651-821, kyw@ntu.edu.tw
About this study
Non-invasive ventilation (NIV) has been widely used in heart failure patients with supporting evidence. However, the drawbacks and contraindications associated with NIV limit its applicability in certain patients. Recently, high-flow oxygen therapy (HFOT) has gained popularity, particularly in the context of the COVID-19 pandemic, due to its documented benefits, improved patient comfort and fewer contraindications. Studies have suggested that HFOT can generate positive end-expiratory pressure (PEEP) similar to NIV, thereby increasing end-expiratory lung volume. However, the specific effects of PEEP remain unknown, as previous research only monitored the upper airway pressure. Therefore, this study aims to explore the flow-pressure relationship between HFOT and NIV in heart failure patients using electrical impedance tomography (EIT).
This prospective randomized crossover clinical trial will be conducted at a single medical center with multiple intensive care units. Participants will be randomly assigned to Groups A and B using a computerized randomization process. Each group will undergo specific protocols for 5-10 minutes per phase, during which parameters including respiratory rate, heart rate, blood pressure, peripheral oxygen saturation, and oxygen concentration will be recorded. NIV will be administered in continuous positive airway pressure (CPAP) mode. Additional parameters such as tidal volume, respiratory rate, minute ventilation, leak flow, and peak inspiratory pressure will be recorded for NIV.
Read more
The study protocols for Group A will follow the sequence of oxygen mask, HFOT 40L, HFOT 50L, HFOT 60L, oxygen mask, CPAP 4cmH2O, CPAP 5cmH2O, and CPAP 6cmH2O. Group B will follow the sequence of oxygen mask, CPAP 4cmH2O, CPAP 5cmH2O, CPAP 6cmH2O, oxygen mask, HFOT 40L, HFOT 50L, and HFOT 60L. This means that each intervention will be performed in the order listed, with one intervention completed before moving on to the next.
The participants will be positioned in a semi-recumbent position at 45 degrees, and the EIT belt will be placed around the fifth (or sixth) intercostal space for monitoring. The EIT signals will be filtered with a cut-off frequency set at 10 beats below the current heart rate. The entire procedure is estimated to take approximately 1-1.5 hours, and recalibration will only be performed in case of significant signal abnormalities. All data will be stored for offline analysis.
Read the detailed description
Non-invasive ventilation (NIV) has been widely used in heart failure patients with supporting evidence. However, the drawbacks and contraindications associated with NIV limit its applicability in certain patients. Recently, high-flow oxygen therapy (HFOT) has gained popularity, particularly in the context of the COVID-19 pandemic, due to its documented benefits, improved patient comfort and fewer contraindications. Studies have suggested that HFOT can generate positive end-expiratory pressure (PEEP) similar to NIV, thereby increasing end-expiratory lung volume. However, the specific effects of PEEP remain unknown, as previous research only monitored the upper airway pressure. Therefore, this study aims to explore the flow-pressure relationship between HFOT and NIV in heart failure patients using electrical impedance tomography (EIT).
This prospective randomized crossover clinical trial will be conducted at a single medical center with multiple intensive care units. Participants will be randomly assigned to Groups A and B using a computerized randomization process. Each group will undergo specific protocols for 5-10 minutes per phase, during which parameters including respiratory rate, heart rate, blood pressure, peripheral oxygen saturation, and oxygen concentration will be recorded. NIV will be administered in continuous positive airway pressure (CPAP) mode. Additional parameters such as tidal volume, respiratory rate, minute ventilation, leak flow, and peak inspiratory pressure will be recorded for NIV.
The study protocols for Group A will follow the sequence of oxygen mask, HFOT 40L, HFOT 50L, HFOT 60L, oxygen mask, CPAP 4cmH2O, CPAP 5cmH2O, and CPAP 6cmH2O. Group B will follow the sequence of oxygen mask, CPAP 4cmH2O, CPAP 5cmH2O, CPAP 6cmH2O, oxygen mask, HFOT 40L, HFOT 50L, and HFOT 60L. This means that each intervention will be performed in the order listed, with one intervention completed before moving on to the next.
The participants will be positioned in a semi-recumbent position at 45 degrees, and the EIT belt will be placed around the fifth (or sixth) intercostal space for monitoring. The EIT signals will be filtered with a cut-off frequency set at 10 beats below the current heart rate. The entire procedure is estimated to take approximately 1-1.5 hours, and recalibration will only be performed in case of significant signal abnormalities. All data will be stored for offline analysis.
The primary outcome will compare the difference of global end-expiratory lung impedance (ΔEELI) between HFOT with a flow rate of 40 L/min and NIV with CPAP 4 cmH2O. The secondary study aims to assess the corresponding PEEP values in NIV with CPAP under different airflow rates during HFOT.
- Being tested
- Non-invasive ventilation (NIV) or high-flow oxygen therapy (HFOT) using electrical impedance tomography (EIT)
- Keywords
- Electrical Impedance Tomography, non-invasive ventilator, high flow oxygen therapy, Positive end-expiratory pressure, Continuous positive airway pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive ventilation (NIV) or high-flow oxygen therapy (HFOT) using electrical impedance tomography (EIT)Device
Participants will be randomly assigned to Groups A and B using a computerized randomization process. Each group will undergo specific protocols for 5-10 minutes per phase. NIV will be administered in continuous positive airway pressure (CPAP) mode. The participants will be positioned in a semi-recumbent position at 45 degrees, and the EIT belt will be placed around the fifth (or sixth) intercostal space for monitoring. The EIT signals will be filtered with a cut-off frequency set at 10 beats below the current heart rate. The entire procedure is estimated to take approximately 1-1.5 hours, and recalibration will only be performed in case of significant signal abnormalities.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Other | follow the sequence of oxygen mask, HFOT 40L, HFOT 50L, HFOT 60L, oxygen mask, CPAP 4cmH2O, CPAP 5cmH2O, and CPAP 6cmH2O. Receives: Device: Non-invasive ventilation (NIV) or high-flow oxygen therapy (HFOT) using electrical impedance tomography (EIT) |
| Group B | Other | follow the sequence of oxygen mask, CPAP 4cmH2O, CPAP 5cmH2O, CPAP 6cmH2O, oxygen mask, HFOT 40L, HFOT 50L, and HFOT 60L. Receives: Device: Non-invasive ventilation (NIV) or high-flow oxygen therapy (HFOT) using electrical impedance tomography (EIT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
compare the difference of global end-expiratory lung impedance (ΔEELI) between HFOT and NIV
compare the difference of global end-expiratory lung impedance (ΔEELI) between HFOT with a flow rate of 40 L/min and NIV with CPAP 4 cmH2O.
Measured: approximately 1-1.5 hours
Secondary outcomes (1)
PEEP values in NIV with CPAP under different airflow rates during HFOT
assess the ΔEELI corresponding PEEP values in NIV with CPAP under different airflow rates during HFOT
Measured: approximately 1-1.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start15 Nov 2023
- Primary completionDec 2024 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for to Assess the Corresponding PEEP Values in NIV With CPAP Under Different Airflow Rates During HFOT in Heart Failure PatientsStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- MING-HANN SHIN, Principal investigator, Division of Respiratory Therapy, Department of Integrated Diagnostic and Therapeutics, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06107907
- Sponsor's protocol ID
- 202307158DINA
- Status last verified
- Oct 2024
- First submitted
- 16 Oct 2023
- Last updated
- 18 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mauri T, Turrini C, Eronia N, Grasselli G, Volta CA, Bellani G, Pesenti A. Physiologic Effects of High-Flow Nasal Cannula in Acute Hypoxemic Respiratory Failure. Am J Respir Crit Care Med. 2017 May 1;195(9):1207-1215. doi: 10.1164/rccm.201605-0916OC.
PubMed 27997805Plotnikow GA, Thille AW, Vasquez DN, Pratto RA, Quiroga CM, Andrich ME, Dorado JH, Gomez RS, D'Annunzio PA, Scapellato JL, Intile D. Effects of High-Flow Nasal Cannula on End-Expiratory Lung Impedance in Semi-Seated Healthy Subjects. Respir Care. 2018 Aug;63(8):1016-1023. doi: 10.4187/respcare.06031. Epub 2018 Jun 26.
PubMed 29945910Yuan Z, Han X, Wang L, Xue P, Sun Y, Frerichs I, Moller K, Xing J, Zhao Z. Oxygen Therapy Delivery and Body Position Effects Measured With Electrical Impedance Tomography. Respir Care. 2020 Mar;65(3):281-287. doi: 10.4187/respcare.07109. Epub 2019 Nov 26.
PubMed 31772064Mauri T, Alban L, Turrini C, Cambiaghi B, Carlesso E, Taccone P, Bottino N, Lissoni A, Spadaro S, Volta CA, Gattinoni L, Pesenti A, Grasselli G. Optimum support by high-flow nasal cannula in acute hypoxemic respiratory failure: effects of increasing flow rates. Intensive Care Med. 2017 Oct;43(10):1453-1463. doi: 10.1007/s00134-017-4890-1. Epub 2017 Jul 31.
PubMed 28762180Parke RL, Bloch A, McGuinness SP. Effect of Very-High-Flow Nasal Therapy on Airway Pressure and End-Expiratory Lung Impedance in Healthy Volunteers. Respir Care. 2015 Oct;60(10):1397-403. doi: 10.4187/respcare.04028. Epub 2015 Sep 1.
PubMed 26329355Nielsen KR, Ellington LE, Gray AJ, Stanberry LI, Smith LS, DiBlasi RM. Effect of High-Flow Nasal Cannula on Expiratory Pressure and Ventilation in Infant, Pediatric, and Adult Models. Respir Care. 2018 Feb;63(2):147-157. doi: 10.4187/respcare.05728. Epub 2017 Oct 24.
PubMed 29066588Zhang R, He H, Yun L, Zhou X, Wang X, Chi Y, Yuan S, Zhao Z. Effect of postextubation high-flow nasal cannula therapy on lung recruitment and overdistension in high-risk patient. Crit Care. 2020 Mar 6;24(1):82. doi: 10.1186/s13054-020-2809-7.
PubMed 32143664Perez-Teran P, Marin-Corral J, Dot I, Sans S, Munoz-Bermudez R, Bosch R, Vila C, Masclans JR. Aeration changes induced by high flow nasal cannula are more homogeneous than those generated by non-invasive ventilation in healthy subjects. J Crit Care. 2019 Oct;53:186-192. doi: 10.1016/j.jcrc.2019.06.009. Epub 2019 Jun 19.
PubMed 31254850
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Electrical Impedance Tomography to Investigate the Relationship Between Airflow Rate During High-flow Oxygen Therapy and Pressure in Patients With Heart Failure Compared to Non-invasive Ventilation
- ClinicalTrials.gov ID
- NCT06107907
- Acronym / sponsor ID
- 202307158DINA
- Keywords
- Electrical Impedance Tomography, non-invasive ventilator, high flow oxygen therapy, Positive end-expiratory pressure, Continuous positive airway pressure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 30 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Non-invasive ventilation (NIV) has been widely used in heart failure patients with supporting evidence. However, the drawbacks and contraindications associated with NIV limit its applicability in certain patients. Recently, high-flow oxygen therapy (HFOT) has gained popularity, particularly in the context of the COVID-19 pandemic, due to its documented benefits, improved patient comfort and fewer contraindications. Studies have suggested that HFOT can generate positive end-expiratory pressure (PEEP) similar to NIV, thereby increasing end-expiratory lung volume. However, the specific effects of PEEP remain unknown, as previous research only monitored the upper airway pressure. Therefore, this study aims to explore the flow-pressure relationship between HFOT and NIV in heart failure patients using electrical impedance tomography (EIT).
This prospective randomized crossover clinical trial will be conducted at a single medical center with multiple intensive care units. Participants will be randomly assigned to Groups A and B using a computerized randomization process. Each group will undergo specific protocols for 5-10 minutes per phase, during which parameters including respiratory rate, heart rate, blood pressure, peripheral oxygen saturation, and oxygen concentration will be recorded. NIV will be administered in continuous positive airway pressure (CPAP) mode. Additional parameters such as tidal volume, respiratory rate, minute ventilation, leak flow, and peak inspiratory pressure will be recorded for NIV.
The study protocols for Group A will follow the sequence of oxygen mask, HFOT 40L, HFOT 50L, HFOT 60L, oxygen mask, CPAP 4cmH2O, CPAP 5cmH2O, and CPAP 6cmH2O. Group B will follow the sequence of oxygen mask, CPAP 4cmH2O, CPAP 5cmH2O, CPAP 6cmH2O, oxygen mask, HFOT 40L, HFOT 50L, and HFOT 60L. This means that each intervention will be performed in the order listed, with one intervention completed before moving on to the next.
The participants will be positioned in a semi-recumbent position at 45 degrees, and the EIT belt will be placed around the fifth (or sixth) intercostal space for monitoring. The EIT signals will be filtered with a cut-off frequency set at 10 beats below the current heart rate. The entire procedure is estimated to take approximately 1-1.5 hours, and recalibration will only be performed in case of significant signal abnormalities. All data will be stored for offline analysis.
Detailed description
Non-invasive ventilation (NIV) has been widely used in heart failure patients with supporting evidence. However, the drawbacks and contraindications associated with NIV limit its applicability in certain patients. Recently, high-flow oxygen therapy (HFOT) has gained popularity, particularly in the context of the COVID-19 pandemic, due to its documented benefits, improved patient comfort and fewer contraindications. Studies have suggested that HFOT can generate positive end-expiratory pressure (PEEP) similar to NIV, thereby increasing end-expiratory lung volume. However, the specific effects of PEEP remain unknown, as previous research only monitored the upper airway pressure. Therefore, this study aims to explore the flow-pressure relationship between HFOT and NIV in heart failure patients using electrical impedance tomography (EIT).
This prospective randomized crossover clinical trial will be conducted at a single medical center with multiple intensive care units. Participants will be randomly assigned to Groups A and B using a computerized randomization process. Each group will undergo specific protocols for 5-10 minutes per phase, during which parameters including respiratory rate, heart rate, blood pressure, peripheral oxygen saturation, and oxygen concentration will be recorded. NIV will be administered in continuous positive airway pressure (CPAP) mode. Additional parameters such as tidal volume, respiratory rate, minute ventilation, leak flow, and peak inspiratory pressure will be recorded for NIV.
The study protocols for Group A will follow the sequence of oxygen mask, HFOT 40L, HFOT 50L, HFOT 60L, oxygen mask, CPAP 4cmH2O, CPAP 5cmH2O, and CPAP 6cmH2O. Group B will follow the sequence of oxygen mask, CPAP 4cmH2O, CPAP 5cmH2O, CPAP 6cmH2O, oxygen mask, HFOT 40L, HFOT 50L, and HFOT 60L. This means that each intervention will be performed in the order listed, with one intervention completed before moving on to the next.
The participants will be positioned in a semi-recumbent position at 45 degrees, and the EIT belt will be placed around the fifth (or sixth) intercostal space for monitoring. The EIT signals will be filtered with a cut-off frequency set at 10 beats below the current heart rate. The entire procedure is estimated to take approximately 1-1.5 hours, and recalibration will only be performed in case of significant signal abnormalities. All data will be stored for offline analysis.
The primary outcome will compare the difference of global end-expiratory lung impedance (ΔEELI) between HFOT with a flow rate of 40 L/min and NIV with CPAP 4 cmH2O. The secondary study aims to assess the corresponding PEEP values in NIV with CPAP under different airflow rates during HFOT.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Other | Device: Non-invasive ventilation (NIV) or high-flow oxygen therapy (HFOT) using electrical impedance tomography (EIT)follow the sequence of oxygen mask, HFOT 40L, HFOT 50L, HFOT 60L, oxygen mask, CPAP 4cmH2O, CPAP 5cmH2O, and CPAP 6cmH2O. |
| Group B | Other | Device: Non-invasive ventilation (NIV) or high-flow oxygen therapy (HFOT) using electrical impedance tomography (EIT)follow the sequence of oxygen mask, CPAP 4cmH2O, CPAP 5cmH2O, CPAP 6cmH2O, oxygen mask, HFOT 40L, HFOT 50L, and HFOT 60L. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients in the intensive care unit (ICU) with PaO2/FiO2 ≤ 300, requiring Non-Invasive Ventilation (NIV) and High-Flow Oxygen Therapy (HFOT) and stable use of NIV and HFOT for at least 24 hours will be eligible for enrollment.
- Evidence of pulmonary infiltrates on chest X-ray in patients with heart failure.
- Alert and able to follow instructions.
Key exclusion criteria (7 listed)
- Age < 18 years.
- Patients with a history of tracheostomy.
- Hemodynamically unstable (defined as a mean arterial pressure persistently below 60 mmHg despite fluid resuscitation or vasopressor support).
- Severe chronic obstructive pulmonary disease (COPD).
- History of nasal trauma and/or nasal septal deviation or any other reason preventing the use of High-Flow Oxygen Therapy (HFOT).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-invasive ventilation (NIV) or high-flow oxygen therapy (HFOT) using electrical impedance tomography (EIT)Participants will be randomly assigned to Groups A and B using a computerized randomization process. Each group will undergo specific protocols for 5-10 minutes per phase. NIV will be administered in continuous positive airway pressure (CPAP) mode. The participants will be positioned in a semi-recumbent position at 45 degrees, and the EIT belt will be placed around the fifth (or sixth) intercostal space for monitoring. The EIT signals will be filtered with a cut-off frequency set at 10 beats below the current heart rate. The entire procedure is estimated to take approximately 1-1.5 hours, and recalibration will only be performed in case of significant signal abnormalities. | Device | Group A, Group B |
Primary outcome
compare the difference of global end-expiratory lung impedance (ΔEELI) between HFOT and NIV
Time frame: approximately 1-1.5 hours
compare the difference of global end-expiratory lung impedance (ΔEELI) between HFOT with a flow rate of 40 L/min and NIV with CPAP 4 cmH2O.
1 secondary outcome
PEEP values in NIV with CPAP under different airflow rates during HFOT
Time frame: approximately 1-1.5 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2024.
- Background: PubMed 27997805Mauri T, Turrini C, Eronia N, Grasselli G, Volta CA, Bellani G, Pesenti A. Physiologic Effects of High-Flow Nasal Cannula in Acute Hypoxemic Respiratory Failure. Am J Respir Crit Care Med. 2017 May 1;195(9):1207-1215. doi: 10.1164/rccm.201605-0916OC.
- Background: PubMed 29945910Plotnikow GA, Thille AW, Vasquez DN, Pratto RA, Quiroga CM, Andrich ME, Dorado JH, Gomez RS, D'Annunzio PA, Scapellato JL, Intile D. Effects of High-Flow Nasal Cannula on End-Expiratory Lung Impedance in Semi-Seated Healthy Subjects. Respir Care. 2018 Aug;63(8):1016-1023. doi: 10.4187/respcare.06031. Epub 2018 Jun 26.
- Background: PubMed 31772064Yuan Z, Han X, Wang L, Xue P, Sun Y, Frerichs I, Moller K, Xing J, Zhao Z. Oxygen Therapy Delivery and Body Position Effects Measured With Electrical Impedance Tomography. Respir Care. 2020 Mar;65(3):281-287. doi: 10.4187/respcare.07109. Epub 2019 Nov 26.
- Results publication: PubMed 28762180Mauri T, Alban L, Turrini C, Cambiaghi B, Carlesso E, Taccone P, Bottino N, Lissoni A, Spadaro S, Volta CA, Gattinoni L, Pesenti A, Grasselli G. Optimum support by high-flow nasal cannula in acute hypoxemic respiratory failure: effects of increasing flow rates. Intensive Care Med. 2017 Oct;43(10):1453-1463. doi: 10.1007/s00134-017-4890-1. Epub 2017 Jul 31.
- Results publication: PubMed 26329355Parke RL, Bloch A, McGuinness SP. Effect of Very-High-Flow Nasal Therapy on Airway Pressure and End-Expiratory Lung Impedance in Healthy Volunteers. Respir Care. 2015 Oct;60(10):1397-403. doi: 10.4187/respcare.04028. Epub 2015 Sep 1.
- Results publication: PubMed 29066588Nielsen KR, Ellington LE, Gray AJ, Stanberry LI, Smith LS, DiBlasi RM. Effect of High-Flow Nasal Cannula on Expiratory Pressure and Ventilation in Infant, Pediatric, and Adult Models. Respir Care. 2018 Feb;63(2):147-157. doi: 10.4187/respcare.05728. Epub 2017 Oct 24.
- Results publication: PubMed 32143664Zhang R, He H, Yun L, Zhou X, Wang X, Chi Y, Yuan S, Zhao Z. Effect of postextubation high-flow nasal cannula therapy on lung recruitment and overdistension in high-risk patient. Crit Care. 2020 Mar 6;24(1):82. doi: 10.1186/s13054-020-2809-7.
- Results publication: PubMed 31254850Perez-Teran P, Marin-Corral J, Dot I, Sans S, Munoz-Bermudez R, Bosch R, Vila C, Masclans JR. Aeration changes induced by high flow nasal cannula are more homogeneous than those generated by non-invasive ventilation in healthy subjects. J Crit Care. 2019 Oct;53:186-192. doi: 10.1016/j.jcrc.2019.06.009. Epub 2019 Jun 19.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
MING-HANN SHIN principal investigator
Division of Respiratory Therapy, Department of Integrated Diagnostic and Therapeutics, National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive ventilation (NIV) or high-flow oxygen therapy (HFOT) using electrical impedance tomography (EIT) in people with to Assess the Corresponding PEEP Values in NIV With CPAP Under Different Airflow Rates During HFOT in Heart Failure Patients, run by National Taiwan University Hospital at 1 site in Taiwan.
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 3 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 18 Oct 2024. 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 Taiwan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact MING-HANN SHIN (+886934017034, x106731@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
compare the difference of global end-expiratory lung impedance (ΔEELI) between HFOT and NIV (time frame: approximately 1-1.5 hours). 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 NCT06107907, which also lists 8 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 18 Oct 2024.