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

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Postextubation High-Flow Nasal Cannula vs Noninvasive Ventilation on Reintubation and Postextubation Respiratory Failure in Patients With Hypercapnic COPD，a Randomized Controlled Trial

Conditions
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High-Flow Nasal Cannula, COPD

Intervention / Treatment
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* Device: High-FlowNasal Cannula
* Device: Noninvasive Ventilation


Participation Criteria
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Eligibility Criteria
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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
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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: High-Flow Nasal Cannula<br>High-flow oxygen was applied immediately after extubation through specific nasal cannula. | Device: High-FlowNasal Cannula<br>* High-flowoxygenwas applied immediately after extubation through specific nasal cannula. Flow was initially set at 10 L/min and titrated upwards in 5-L/min steps until patients experienced discomfort.Temperature was initially set to 37°C, unless reported too hot by patients, and FIO2 was regularly adjusted to the target peripheral capillary oxygen saturation (SPO2) of greater than 92%. After 24 hours, high-flow was stopped and, if necessary, patients received conventional oxygen therapy.<br>|
| Other: Noninvasive Ventilation<br>Noninvasive Ventilation was applied immediately after extubation. | Device: Noninvasive Ventilation<br>* Full face mask NIV was continuously delivered immediately after extubation for a scheduled period of 24 hours after extubation. Afterward, NIV was withdrawn and oxygen was administered by Venturi mask.Both PEEP and inspiratory pressure supportwere adjusted to target a respiratory rate of 25/min and adequate gas exchange (arterial oxygen saturation [SaO2] 92%, with pH of 7.35). The FIO2 was adjusted to maintain SPO2 at less than 92%. Sedatives to increase tolerance to NIV were not allowed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of reintubation | The proportion of patients requiring reintubation within 72 hours after extubation | Within 72 hours after extubation | 

Secondary Outcome Measures

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