HFNC vs NPPV After Early Extubation for Patients With COPD

Not Applicable

• Conditions: COPD; Hypercapnic Respiratory Failure
• Interventions: Device: HFNC; Device: NPPV

• Registration Number: NCT04156139
• Lead Sponsor: Chinese PLA General Hospital

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2019-11-01
• Study First Submitted QC: 2019-11-05
• Study First Posted: 2019-11-07
• Study Start: 2019-12-18
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-22
• Last Update Posted: 2020-01-23
• Primary Completion: 2022-05-01
• Study Completion: 2022-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 502

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention group	NPPV	HFNC treatment will be performed for patients immediately after extubation in the intervention group.
Control group	HFNC	NPPV treatment for patients will be performed for patients immediately after extubation in control group.
Control group	NPPV	NPPV treatment for patients will be performed for patients immediately after extubation in control group.
intervention group	HFNC	HFNC treatment will be performed for patients immediately after extubation in the intervention group.

Primary Outcome Measures

Name	Time	Method
reintubation	within the 7 days after extubation.	The primary outcome is reintubation within the 7 days after extubation.

Secondary Outcome Measures

Name	Time	Method
Weaning failure	within the7 days after extubation	Secondary Outcome is a composite criterion including reintubation events or all-cause deaths within the7 days after extubation

Trial Locations

Locations (1)

Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China