Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06582459

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The First People's Hospital of Neijiang City

Neijiang, Sichuan, 641000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Inclusion criteria are patients aged ≥ 18 years old;
  • 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).

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

    defined as the avoidance of endotracheal intubation or death during hospitalization

Sponsors and collaborators

Lead sponsor

The First People's Hospital of Neijiang

Other

Registry information

Official study 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

Acronym: HFCNV-PAH

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Sep 3, 2024
Registry last updated
Sep 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.