Effect of Postextubation High-Flow Nasal Cannula vs Noninvasive Ventilation in Patients With Hypercapnic COPD

Not Applicable

• Conditions: High-Flow Nasal Cannula; COPD
• Interventions: Device: High-FlowNasal Cannula; Device: Noninvasive Ventilation

• Registration Number: NCT03928535
• Lead Sponsor: Xiangya Hospital of Central South University

Brief Summary

To test if high-flow conditioned oxygen therapy is noninferior to NIV for preventing postextubation respiratory failure and reintubation in patients with hypercapnic COPD, investigators plan to conduct the participants level, 1:1 randomized trial at the respiratory ICU. Participants were randomized to undergo either high-flow conditioned oxygen therapy or noninvasive mechanical ventilation after extubation. Primary outcomes were reintubation and postextubation respiratory failure within 72 hours. Secondary outcomes included length of RICU stay after extubation and mortality; partial pressure of arterial carbon dioxide.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05-01
• Status Verified: 2018-12
• Study First Submitted: 2019-04-13
• Study First Submitted QC: 2019-04-24
• Last Update Submitted: 2019-04-24
• Study First Posted: 2019-04-26
• Last Update Posted: 2019-04-26
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Clinical diagnosis of AECOPD
• Extubation must be performed after 48 hours of invasive ventilation
• Must be treated sequentially with HFNC or NIV after extubation
• PaCO2≥50mmHg when extubation
• Positive End Expiratory Pressure (PEEP) ≤8cmH2O (1cmH2O=0.098 kPa) when extubation

Exclusion Criteria

• Do-not-intubate
• Tracheostomies
• Accidental extubation
• Self-extubation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High-Flow Nasal Cannula	High-FlowNasal Cannula	High-flow oxygen was applied immediately after extubation through specific nasal cannula.
Noninvasive Ventilation	Noninvasive Ventilation	Noninvasive Ventilation was applied immediately after extubation.

Primary Outcome Measures

Name	Time	Method
Rate of reintubation	Within 72 hours after extubation	The proportion of patients requiring reintubation within 72 hours after extubation

Secondary Outcome Measures

Name	Time	Method
Mortality	Within 28 days after extubation	Mortality after extubation
RICU length of stay after extubation	From date of extubation until the date of discharging from the RICU up to 28 days	Length of time from extubation to discharging from the RICU
Partial pressure of arterial carbon dioxide	Within 24 hours before extubation and within 72 hours after extubation	Partial pressure of arterial carbon dioxide tested at the appointed time

Trial Locations

Locations (1)

Xiangya Hospital; 🇨🇳 Changsha, Hunan, China