Pulmonary Arterial HypertensionHFCNV-PAHNCT06582459
Efficacy and Safety of High-Flow Nasal Cannula Versus Noninvasive Ventilation for Pulmonary Arterial Hypertension-Associated Acute Respiratory Failure
An observational study of Pulmonary Arterial Hypertension and Acute Respiratory Failure, run by The First People's Hospital of Neijiang at 1 site in China.
Trial summary
This is a single center, retrospective, propensity score matching cohort study that explores the efficacy and safety of high flow nasal cannula and non-invasive ventilation in the treatment of acute respiratory failure associated with pulmonary arterial hypertension, stratified by the severity of right ventricular… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Pulmonary Arterial Hypertension, Acute Respiratory Failure, High-flow Nasal Cannula
- What is being tested?
- HFNC treatment and NIV treatment
- Type of treatment
- Medical device
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 1 Jan 2025
- Phase
- Observational
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 1. Inclusion criteria are patients aged ≥ 18 years old； 2. Patients diagnosed with PH based on right ventricular systolic pressure (RVSP)>50 mmHg on echocardiography or right heart catheterization (resting mean pulmonary artery pressure ≥ 25 mmHg)； 3. And patients who require HFNC or NIV respiratory support after ACRF (defined as acute deterioration of respiratory function in patients with chronic respiratory diseases, resulting in PaO2<60 mmHg, PaO2/FiO2 ratio<300 mmHg, or respiratory rate>30 breaths per minute in indoor air).
Who may be able to join
- Patients diagnosed with PH based on right ventricular systolic pressure (RVSP)>50 mmHg on echocardiography or right heart catheterization (resting mean pulmonary artery pressure ≥ 25 mmHg)；
- And patients who require HFNC or NIV respiratory support after ACRF (defined as acute deterioration of respiratory function in patients with chronic respiratory diseases, resulting in PaO2<60 mmHg, PaO2/FiO2 ratio<300 mmHg, or respiratory rate>30 breaths per minute in indoor air).
Who cannot join
- The exclusion criteria were patients with acute coronary syndrome, acute myocardial infarction, severe arrhythmias, severe cerebrovascular or neurological diseases, and severe hepatic or renal dysfunction;
- those who were receiving endotracheal intubation or NIV within 24 h of admission;
- patients who were not intubated;
- those who were receiving palliative care;
- immunocompromised patients;
- patients with incomplete data or who were lost to follow-up.
Trial locations and contacts
1 site in 1 country.
China1 site
The First People's Hospital of Neijiang City
Neijiang, Sichuan, 641000
About this study
Official title: Efficacy and Safety of High-Flow Nasal Cannula Versus Noninvasive Ventilation for Pulmonary Arterial Hypertension-Associated Acute Respiratory Failure: A Retrospective Cohort Study Stratified by Right Ventricular Dysfunction Severity
This is a single center, retrospective, propensity score matching cohort study that explores the efficacy and safety of high flow nasal cannula and non-invasive ventilation in the treatment of acute respiratory failure associated with pulmonary arterial hypertension, stratified by the severity of right ventricular dysfunction.
The study will compare two groups: high flow nasal cannula (HFNC) and non-invasive ventilation (NIV).
Read more
Main objective: heart function parameters (e.g. TAPSE and RVSP) Secondary objectives: respiratory support success rate (defined as the avoidance of endotracheal introduction or death duration hospitalization), respiratory support duration, length of intensive care unit (ICU) stay, length of hospital stay, and in-hospital mortality.
This study addresses whether NIV or HFNC should be prioritized for the treatment of acute respiratory failure associated with pulmonary arterial hypertension in patients with severe right ventricular dysfunction who require high flow nasal cannula and non-invasive ventilation.
This study is of great significance as it is based on a patient stratification method of right ventricular dysfunction severity to evaluate the effectiveness of HFNC treatment and NIV in PH related ARF patients.
Read the detailed description
Study Title: Efficiency and Safety of High Flow Nassal Cannula Versus Noninvasive Ventilation for Pulsary Arterial Hypertension Associated Acute Respiratory Failure: A Retrospective Cohort Study Stratified by Right Ventricular Dysfunction Severity Background: Patients with pulmonary hypertension (PH) typically have high morbidity and mortality when they develop acute respiratory failure (ARF) The best method of respiratory support considering the severity of right ventricular (RV) dysfunction is still uncertain.
Main objective: heart function parameters (e.g. TAPSE and RVSP) Secondary objectives: respiratory support success rate (defined as the avoidance of endotracheal introduction or death duration hospitalization), respiratory support duration, length of intensive care unit (ICU) stay, length of hospital stay, and in-hospital mortality.
Research Design: This is a single center, retrospective, propensity score matching cohort study.
The study will compare two groups: high flow nasal cannula (HFNC) and non-invasive ventilation (NIV).
Significance: This study aims to address whether NIV or HFNC should be prioritized for the treatment of acute respiratory failure associated with pulmonary arterial hypertension in patients with severe right ventricular dysfunction who require high flow nasal cannula and non-invasive ventilation.
Innovation: A patient stratification method based on the severity of right ventricular dysfunction to evaluate the effectiveness of HFNC treatment and NIV in PH related ARF patients.
Expected outcome: HFNC treatment is equally effective as NIV in treating mild to moderate right ventricular dysfunction; NIV may be more beneficial for critically ill patients. Assist PH patients with ARF in choosing between HFNC treatment and NIV.
Conclusion: Our study provides new insights into the comparative performance of HFNC therapy and NIV in patients with PH combined with ARF.
- Conditions
- Pulmonary Arterial Hypertension, Acute Respiratory Failure, High-flow Nasal Cannula, Noninvasive Ventilation
- Being tested
- HFNC treatment, NIV treatment
- Keywords
- Pulmonary hypertension, Acute respiratory failure, High-flow nasal cannula, Noninva-sive ventilation, Right ventricular dysfunction
- Medical subject headings
- Pulmonary Arterial Hypertension, Hypertension, Pulmonary, Ventricular Dysfunction, Right
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HFNC treatmentDevice
HFNC treatment HFNC therapy. The initial flow rate of 50-60 L/min was subsequently adjusted to maintain an oxygen saturation (SpO2) ≥92%. The FiO2 was titrated to maintain the PaO2 between 60 and 80 mmHg.
NIV treatmentDevice
NIV treatment A Mindray SV300 ventilator (Mindray Medical International Limited, Shenzhen, China) was used to deliver NIV via an oronasal mask. The initial inspiratory positive airway pressure (IPAP) was 12-15 cmH2O and adjusted later to achieve a tidal volume of 6-8 mL/kg of predicted body weight and a respiratory rate of \&lt;30 breaths/min. The expiratory positive airway pressure (EPAP) was established at 5-8 cmH2O. Additional-ly, FiO2 was titrated to maintain a PaO2 between 60 and 80 mmHg.
| Study group | Role | What they receive |
|---|---|---|
| HFNC treatment | HFNC therapy. The initial flow rate of 50-60 L/min was subsequently adjusted to maintain an oxygen saturation (SpO2) ≥92%. The FiO2 was titrated to maintain the PaO2 between 60 and 80 mmHg. Receives: Device: HFNC treatment | |
| NIV treatment | A Mindray SV300 ventilator (Mindray Medical International Limited, Shenzhen, China) was used to deliver NIV via an oronasal mask. The initial inspiratory positive airway pressure (IPAP) was 12-15 cmH2O and adjusted later to achieve a tidal volume of 6-8 mL/kg of predicted body weight and a respiratory rate of <30 breaths/min. The expiratory positive airway pressure (EPAP) was established at 5-8 cmH2O. Additional-ly, FiO2 was titrated to maintain a PaO2 between 60 and 80 mmHg. Receives: Device: NIV treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
heart function parameters
(e.g., TAPSE and RVSP) from baseline to 24 h after respiratory support initiation.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.
Secondary outcomes (1)
respiratory support success rate
defined as the avoidance of endotracheal intubation or death during hospitalization
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study start1 Jan 2023
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First People's Hospital of Neijiang
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ou Jiang, The First People's Hospital of Neijiang
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06582459
- Sponsor's protocol ID
- 2021-lunshenpi-38
- Acronym
- HFCNV-PAH
- Status last verified
- Aug 2024
- First submitted
- 28 Aug 2024
- Last updated
- 3 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hoeper MM, Humbert M, Souza R, Idrees M, Kawut SM, Sliwa-Hahnle K, Jing ZC, Gibbs JS. A global view of pulmonary hypertension. Lancet Respir Med. 2016 Apr;4(4):306-22. doi: 10.1016/S2213-2600(15)00543-3. Epub 2016 Mar 12.
PubMed 26975810Campo A, Mathai SC, Le Pavec J, Zaiman AL, Hummers LK, Boyce D, Housten T, Lechtzin N, Chami H, Girgis RE, Hassoun PM. Outcomes of hospitalisation for right heart failure in pulmonary arterial hypertension. Eur Respir J. 2011 Aug;38(2):359-67. doi: 10.1183/09031936.00148310. Epub 2011 Feb 10.
PubMed 21310884Sztrymf B, Souza R, Bertoletti L, Jais X, Sitbon O, Price LC, Simonneau G, Humbert M. Prognostic factors of acute heart failure in patients with pulmonary arterial hypertension. Eur Respir J. 2010 Jun;35(6):1286-93. doi: 10.1183/09031936.00070209. Epub 2009 Nov 6.
PubMed 19897557Kurzyna M, Zylkowska J, Fijalkowska A, Florczyk M, Wieteska M, Kacprzak A, Burakowski J, Szturmowicz M, Wawrzynska L, Torbicki A. Characteristics and prognosis of patients with decompensated right ventricular failure during the course of pulmonary hypertension. Kardiol Pol. 2008 Oct;66(10):1033-9; discussion 1040-1.
PubMed 19006024Atwood CW Jr, McCrory D, Garcia JG, Abman SH, Ahearn GS; American College of Chest Physicians. Pulmonary artery hypertension and sleep-disordered breathing: ACCP evidence-based clinical practice guidelines. Chest. 2004 Jul;126(1 Suppl):72S-77S. doi: 10.1378/chest.126.1_suppl.72S.
PubMed 15249496Nishimura M. High-Flow Nasal Cannula Oxygen Therapy in Adults: Physiological Benefits, Indication, Clinical Benefits, and Adverse Effects. Respir Care. 2016 Apr;61(4):529-41. doi: 10.4187/respcare.04577.
PubMed 27016353Rochwerg B, Einav S, Chaudhuri D, Mancebo J, Mauri T, Helviz Y, Goligher EC, Jaber S, Ricard JD, Rittayamai N, Roca O, Antonelli M, Maggiore SM, Demoule A, Hodgson CL, Mercat A, Wilcox ME, Granton D, Wang D, Azoulay E, Ouanes-Besbes L, Cinnella G, Rauseo M, Carvalho C, Dessap-Mekontso A, Fraser J, Frat JP, Gomersall C, Grasselli G, Hernandez G, Jog S, Pesenti A, Riviello ED, Slutsky AS, Stapleton RD, Talmor D, Thille AW, Brochard L, Burns KEA. The role for high flow nasal cannula as a respiratory support strategy in adults: a clinical practice guideline. Intensive Care Med. 2020 Dec;46(12):2226-2237. doi: 10.1007/s00134-020-06312-y. Epub 2020 Nov 17.
PubMed 33201321Nishimura M. High-flow nasal cannula oxygen therapy in adults. J Intensive Care. 2015 Mar 31;3(1):15. doi: 10.1186/s40560-015-0084-5. eCollection 2015.
PubMed 25866645Ferreyro BL, Angriman F, Munshi L, Del Sorbo L, Ferguson ND, Rochwerg B, Ryu MJ, Saskin R, Wunsch H, da Costa BR, Scales DC. Association of Noninvasive Oxygenation Strategies With All-Cause Mortality in Adults With Acute Hypoxemic Respiratory Failure: A Systematic Review and Meta-analysis. JAMA. 2020 Jul 7;324(1):57-67. doi: 10.1001/jama.2020.9524.
PubMed 32496521Simonneau G, Montani D, Celermajer DS, Denton CP, Gatzoulis MA, Krowka M, Williams PG, Souza R. Haemodynamic definitions and updated clinical classification of pulmonary hypertension. Eur Respir J. 2019 Jan 24;53(1):1801913. doi: 10.1183/13993003.01913-2018. Print 2019 Jan.
PubMed 30545968Yu L, Chen X, Wang X, Cui R. Efficacy and safety of high-flow nasal cannula versus noninvasive ventilation for pulmonary arterial hypertension-associated acute respiratory failure: A retrospective cohort study stratified by the severity of right ventricular dysfunction. Medicine (Baltimore). 2025 Jul 4;104(27):e43185. doi: 10.1097/MD.0000000000043185.
PubMed 40629562
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of High-Flow Nasal Cannula Versus Noninvasive Ventilation for Pulmonary Arterial Hypertension-Associated Acute Respiratory Failure: A Retrospective Cohort Study Stratified by Right Ventricular Dysfunction Severity
- ClinicalTrials.gov ID
- NCT06582459
- Acronym / sponsor ID
- HFCNV-PAH / 2021-lunshenpi-38
- Conditions
- Pulmonary Arterial Hypertension, Acute Respiratory Failure, High-flow Nasal Cannula, Noninvasive Ventilation
- Keywords
- Pulmonary hypertension, Acute respiratory failure, High-flow nasal cannula, Noninva-sive ventilation, Right ventricular dysfunction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- The First People's Hospital of NeijiangUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 3 Sep 2024 (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.
This is a single center, retrospective, propensity score matching cohort study that explores the efficacy and safety of high flow nasal cannula and non-invasive ventilation in the treatment of acute respiratory failure associated with pulmonary arterial hypertension, stratified by the severity of right ventricular dysfunction.
The study will compare two groups: high flow nasal cannula (HFNC) and non-invasive ventilation (NIV).
Main objective: heart function parameters (e.g. TAPSE and RVSP) Secondary objectives: respiratory support success rate (defined as the avoidance of endotracheal introduction or death duration hospitalization), respiratory support duration, length of intensive care unit (ICU) stay, length of hospital stay, and in-hospital mortality.
This study addresses whether NIV or HFNC should be prioritized for the treatment of acute respiratory failure associated with pulmonary arterial hypertension in patients with severe right ventricular dysfunction who require high flow nasal cannula and non-invasive ventilation.
This study is of great significance as it is based on a patient stratification method of right ventricular dysfunction severity to evaluate the effectiveness of HFNC treatment and NIV in PH related ARF patients.
Detailed description
Study Title: Efficiency and Safety of High Flow Nassal Cannula Versus Noninvasive Ventilation for Pulsary Arterial Hypertension Associated Acute Respiratory Failure: A Retrospective Cohort Study Stratified by Right Ventricular Dysfunction Severity Background: Patients with pulmonary hypertension (PH) typically have high morbidity and mortality when they develop acute respiratory failure (ARF) The best method of respiratory support considering the severity of right ventricular (RV) dysfunction is still uncertain.
Main objective: heart function parameters (e.g. TAPSE and RVSP) Secondary objectives: respiratory support success rate (defined as the avoidance of endotracheal introduction or death duration hospitalization), respiratory support duration, length of intensive care unit (ICU) stay, length of hospital stay, and in-hospital mortality.
Research Design: This is a single center, retrospective, propensity score matching cohort study.
The study will compare two groups: high flow nasal cannula (HFNC) and non-invasive ventilation (NIV).
Significance: This study aims to address whether NIV or HFNC should be prioritized for the treatment of acute respiratory failure associated with pulmonary arterial hypertension in patients with severe right ventricular dysfunction who require high flow nasal cannula and non-invasive ventilation.
Innovation: A patient stratification method based on the severity of right ventricular dysfunction to evaluate the effectiveness of HFNC treatment and NIV in PH related ARF patients.
Expected outcome: HFNC treatment is equally effective as NIV in treating mild to moderate right ventricular dysfunction; NIV may be more beneficial for critically ill patients. Assist PH patients with ARF in choosing between HFNC treatment and NIV.
Conclusion: Our study provides new insights into the comparative performance of HFNC therapy and NIV in patients with PH combined with ARF.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HFNC treatment | – | Device: HFNC treatmentHFNC therapy. The initial flow rate of 50-60 L/min was subsequently adjusted to maintain an oxygen saturation (SpO2) ≥92%. The FiO2 was titrated to maintain the PaO2 between 60 and 80 mmHg. |
| NIV treatment | – | Device: NIV treatmentA Mindray SV300 ventilator (Mindray Medical International Limited, Shenzhen, China) was used to deliver NIV via an oronasal mask. The initial inspiratory positive airway pressure (IPAP) was 12-15 cmH2O and adjusted later to achieve a tidal volume of 6-8 mL/kg of predicted body weight and a respiratory rate of <30 breaths/min. The expiratory positive airway pressure (EPAP) was established at 5-8 cmH2O. Additional-ly, FiO2 was titrated to maintain a PaO2 between 60 and 80 mmHg. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Inclusion criteria are patients aged ≥ 18 years old； 2. Patients diagnosed with PH based on right ventricular systolic pressure (RVSP)>50 mmHg on echocardiography or right heart catheterization (resting mean pulmonary artery pressure ≥ 25 mmHg)； 3. And patients who require HFNC or NIV respiratory support after ACRF (defined as acute deterioration of respiratory function in patients with chronic respiratory diseases, resulting in PaO2<60 mmHg, PaO2/FiO2 ratio<300 mmHg, or respiratory rate>30 breaths per minute in indoor air).
Key inclusion criteria (2 listed)
- Patients diagnosed with PH based on right ventricular systolic pressure (RVSP)>50 mmHg on echocardiography or right heart catheterization (resting mean pulmonary artery pressure ≥ 25 mmHg)；
- And patients who require HFNC or NIV respiratory support after ACRF (defined as acute deterioration of respiratory function in patients with chronic respiratory diseases, resulting in PaO2<60 mmHg, PaO2/FiO2 ratio<300 mmHg, or respiratory rate>30 breaths per minute in indoor air).
Key exclusion criteria (6 listed)
- The exclusion criteria were patients with acute coronary syndrome, acute myocardial infarction, severe arrhythmias, severe cerebrovascular or neurological diseases, and severe hepatic or renal dysfunction;
- those who were receiving endotracheal intubation or NIV within 24 h of admission;
- patients who were not intubated;
- those who were receiving palliative care;
- immunocompromised patients;
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 |
|---|---|---|
| HFNC treatmentHFNC treatment HFNC therapy. The initial flow rate of 50-60 L/min was subsequently adjusted to maintain an oxygen saturation (SpO2) ≥92%. The FiO2 was titrated to maintain the PaO2 between 60 and 80 mmHg. | Device | HFNC treatment |
| NIV treatmentNIV treatment A Mindray SV300 ventilator (Mindray Medical International Limited, Shenzhen, China) was used to deliver NIV via an oronasal mask. The initial inspiratory positive airway pressure (IPAP) was 12-15 cmH2O and adjusted later to achieve a tidal volume of 6-8 mL/kg of predicted body weight and a respiratory rate of \&lt;30 breaths/min. The expiratory positive airway pressure (EPAP) was established at 5-8 cmH2O. Additional-ly, FiO2 was titrated to maintain a PaO2 between 60 and 80 mmHg. | Device | NIV treatment |
Primary outcome
heart function parameters
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.
(e.g., TAPSE and RVSP) from baseline to 24 h after respiratory support initiation.
1 secondary outcome
respiratory support success rate
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2024.
- Background: PubMed 26975810Hoeper MM, Humbert M, Souza R, Idrees M, Kawut SM, Sliwa-Hahnle K, Jing ZC, Gibbs JS. A global view of pulmonary hypertension. Lancet Respir Med. 2016 Apr;4(4):306-22. doi: 10.1016/S2213-2600(15)00543-3. Epub 2016 Mar 12.
- Background: PubMed 21310884Campo A, Mathai SC, Le Pavec J, Zaiman AL, Hummers LK, Boyce D, Housten T, Lechtzin N, Chami H, Girgis RE, Hassoun PM. Outcomes of hospitalisation for right heart failure in pulmonary arterial hypertension. Eur Respir J. 2011 Aug;38(2):359-67. doi: 10.1183/09031936.00148310. Epub 2011 Feb 10.
- Background: PubMed 19897557Sztrymf B, Souza R, Bertoletti L, Jais X, Sitbon O, Price LC, Simonneau G, Humbert M. Prognostic factors of acute heart failure in patients with pulmonary arterial hypertension. Eur Respir J. 2010 Jun;35(6):1286-93. doi: 10.1183/09031936.00070209. Epub 2009 Nov 6.
- Background: PubMed 19006024Kurzyna M, Zylkowska J, Fijalkowska A, Florczyk M, Wieteska M, Kacprzak A, Burakowski J, Szturmowicz M, Wawrzynska L, Torbicki A. Characteristics and prognosis of patients with decompensated right ventricular failure during the course of pulmonary hypertension. Kardiol Pol. 2008 Oct;66(10):1033-9; discussion 1040-1.
- Background: PubMed 15249496Atwood CW Jr, McCrory D, Garcia JG, Abman SH, Ahearn GS; American College of Chest Physicians. Pulmonary artery hypertension and sleep-disordered breathing: ACCP evidence-based clinical practice guidelines. Chest. 2004 Jul;126(1 Suppl):72S-77S. doi: 10.1378/chest.126.1_suppl.72S.
- Background: PubMed 27016353Nishimura M. High-Flow Nasal Cannula Oxygen Therapy in Adults: Physiological Benefits, Indication, Clinical Benefits, and Adverse Effects. Respir Care. 2016 Apr;61(4):529-41. doi: 10.4187/respcare.04577.
- Background: PubMed 33201321Rochwerg B, Einav S, Chaudhuri D, Mancebo J, Mauri T, Helviz Y, Goligher EC, Jaber S, Ricard JD, Rittayamai N, Roca O, Antonelli M, Maggiore SM, Demoule A, Hodgson CL, Mercat A, Wilcox ME, Granton D, Wang D, Azoulay E, Ouanes-Besbes L, Cinnella G, Rauseo M, Carvalho C, Dessap-Mekontso A, Fraser J, Frat JP, Gomersall C, Grasselli G, Hernandez G, Jog S, Pesenti A, Riviello ED, Slutsky AS, Stapleton RD, Talmor D, Thille AW, Brochard L, Burns KEA. The role for high flow nasal cannula as a respiratory support strategy in adults: a clinical practice guideline. Intensive Care Med. 2020 Dec;46(12):2226-2237. doi: 10.1007/s00134-020-06312-y. Epub 2020 Nov 17.
- Background: PubMed 25866645Nishimura M. High-flow nasal cannula oxygen therapy in adults. J Intensive Care. 2015 Mar 31;3(1):15. doi: 10.1186/s40560-015-0084-5. eCollection 2015.
- Background: PubMed 32496521Ferreyro BL, Angriman F, Munshi L, Del Sorbo L, Ferguson ND, Rochwerg B, Ryu MJ, Saskin R, Wunsch H, da Costa BR, Scales DC. Association of Noninvasive Oxygenation Strategies With All-Cause Mortality in Adults With Acute Hypoxemic Respiratory Failure: A Systematic Review and Meta-analysis. JAMA. 2020 Jul 7;324(1):57-67. doi: 10.1001/jama.2020.9524.
- Results publication: PubMed 30545968Simonneau G, Montani D, Celermajer DS, Denton CP, Gatzoulis MA, Krowka M, Williams PG, Souza R. Haemodynamic definitions and updated clinical classification of pulmonary hypertension. Eur Respir J. 2019 Jan 24;53(1):1801913. doi: 10.1183/13993003.01913-2018. Print 2019 Jan.
- Derived from this study: PubMed 40629562Yu L, Chen X, Wang X, Cui R. Efficacy and safety of high-flow nasal cannula versus noninvasive ventilation for pulmonary arterial hypertension-associated acute respiratory failure: A retrospective cohort study stratified by the severity of right ventricular dysfunction. Medicine (Baltimore). 2025 Jul 4;104(27):e43185. doi: 10.1097/MD.0000000000043185.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Arterial Hypertension and Acute Respiratory Failure, run by The First People's Hospital of Neijiang 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 6 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 3 Sep 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 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
heart function parameters (time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.). 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 NCT06582459, which also lists 11 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 3 Sep 2024.