HFNC vs NPPV After Early Extubation for Patients With COPD

Study Overview
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Brief Summary
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High-flow nasal cannula oxygen therapy(HFNC) has proved no significant difference compared with noninvasive positive pressure ventilation (NPPV) in preventing postextubation respiratory failure and reintubation in patients with acute hypoxemic respiratory failure.However, the efficacy of early postextubation sequential HFNC in COPD patients with hypercapnic respiratory failure is inconclusive.

Detailed Description
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The investigators conducted this prospective randomized controlled trial to explore the efficacy, safety of HFNC versus NPPV after early extubation in COPD patients with hypercapnic respiratory failure.The investigators hypothesized that the efficacy of HFNC after early extubation is non-inferior to that of NPPV.

Official Title
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High-flow Nasal Cannula Versus Noninvasive Positive Pressure Ventilation Therapy After Early Extubation for Patients With Chronic Obstructive Pulmonary Disease

Conditions
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COPD, Hypercapnic Respiratory Failure

Intervention / Treatment
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* Device: HFNC
* Device: NPPV


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. COPD patients with bronchopulmonary infection 2. Patients with hypercapnia respiratory failure treated with invasive mechanical 3.14 days ≥ invasive mechanical ventilation ≥ 48 hours; 4.Reached the pulmonary infection control (PIC) window; 5.Have self-care ability with oxygen supply during stable phrase Exclusion Criteria: Severe organ dysfunction;Myopathy or myasthenia gravis;Upper airway obstruction;A large amount of secretions and inability to drain;

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group<br>NPPV treatment for patients will be performed for patients immediately after extubation in control group. | Device: HFNC<br>* The gas flow rate was set at 45 55 L/min. The inhaled oxygen concentration will be dynamically adjusted to maintain SpO2 ≥ 92%. The temperature will be set at 37 °C.<br>Device: NPPV<br>* The PEEP is initially set as 5 cm H2O, the inspiratory pressure is 10 cm H2O, and the target tidal volume is 6-8 ml/kg.<br>|
| Experimental: intervention group<br>HFNC treatment will be performed for patients immediately after extubation in the intervention group. | Device: HFNC<br>* The gas flow rate was set at 45 55 L/min. The inhaled oxygen concentration will be dynamically adjusted to maintain SpO2 ≥ 92%. The temperature will be set at 37 °C.<br>Device: NPPV<br>* The PEEP is initially set as 5 cm H2O, the inspiratory pressure is 10 cm H2O, and the target tidal volume is 6-8 ml/kg.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reintubation | The primary outcome is reintubation within the 7 days after extubation. | within the 7 days after extubation. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weaning failure | Secondary Outcome is a composite criterion including reintubation events or all-cause deaths within the7 days after extubation | within the7 days after extubation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NPPV, HFNC, Weaning, COPD, PIC