NCT06582459

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

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 90 (estimated)
• Sponsor: The First People's Hospital of Neijiang · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DEVICE	HFNC treatment	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	NIV 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.

Timeline

• Start date: 2023-01-01
• Primary completion: 2025-01-01
• Completion: 2025-01-01
• First posted: 2024-09-03
• Last updated: 2024-09-03

Locations

1 site across 1 country: China