Efficacy and Safety of High-Flow Nasal Cannula Versus Noninvasive Ventilation for Pulmonary Arterial Hypertension-Associated Acute Respiratory Failure

NCT06582459 | Active Not Recruiting DMC

• 1 other identifier: 2021-lunshenpi-38
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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 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.

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

Outcome Measures

Primary Outcomes (1)

• heart function parameters

  (e.g., TAPSE and RVSP) from baseline to 24 h after respiratory support initiation.

  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

  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.

Study Arms (2)

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.

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.

Device: NIV treatment

Interventions

HFNC treatment DEVICE

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.

HFNC treatment

NIV treatment DEVICE

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 \&amp;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.

NIV treatment

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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).

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First People's Hospital of Neijiang: lead

Study Sites (1)

The First People's Hospital of Neijiang City

Neijiang, Sichuan, 641000, China

Location

Related Publications (11)

• Simonneau 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.

  PMID: 30545968 BACKGROUND

• 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.

  PMID: 26975810 BACKGROUND

• Campo 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.

  PMID: 21310884 BACKGROUND

• Sztrymf 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.

  PMID: 19897557 BACKGROUND

• Kurzyna 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.

  PMID: 19006024 BACKGROUND

• Atwood 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.

  PMID: 15249496 BACKGROUND

• Nishimura 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.

  PMID: 27016353 BACKGROUND

• Rochwerg 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.

  PMID: 33201321 BACKGROUND

• Nishimura 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.

  PMID: 25866645 BACKGROUND

• Ferreyro 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.

  PMID: 32496521 BACKGROUND

• Yu 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.

  PMID: 40629562 DERIVED

MeSH Terms

Conditions

Pulmonary Arterial Hypertension; Hypertension, Pulmonary; Ventricular Dysfunction, Right

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Ventricular Dysfunction; Heart Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Cancer Center

Study Record Dates

• First Submitted: August 28, 2024
• First Posted: September 3, 2024
• Study Start: January 1, 2023
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: September 3, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)