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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06582459
Acronym
HFCNV-PAH
Enrollment
90
Registered
2024-09-03
Start date
2023-01-01
Completion date
2025-01-01
Last updated
2024-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Failure, High-flow Nasal Cannula, Noninvasive Ventilation, Pulmonary Arterial Hypertension

Keywords

Pulmonary hypertension, Acute respiratory failure, High-flow nasal cannula, Noninva-sive ventilation, Right ventricular dysfunction

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.

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.

Interventions

DEVICEHFNC 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.

DEVICENIV 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.

Sponsors

The First People's Hospital of Neijiang
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
heart function parametersFrom 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

MeasureTime frameDescription
respiratory support success rateFrom 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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026