Clinical trial NCT06582459: Efficacy and Safety of High-Flow Nasal Cannula Versus Noninvasive Ventilation for Pulmonary Arterial Hypertension-Associated Acute Respiratory Failure
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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
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
Lead sponsor: The First People's Hospital of Neijiang
Sponsor class: OTHER
First posted: 2024-09-03
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: heart function parameters
timeFrame: 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:
measure: respiratory support success rate
timeFrame: 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.
Other outcomes:
Locations:
city: Neijiang
country: China
facility: The First People's Hospital of Neijiang City
state: Sichuan
Study officials:
References:
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