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

Xiangya Hospital of Central South University100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

100

Conditions

High-Flow Nasal Cannula COPD

Interventions

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.

Noninvasive VentilationDEVICE

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 Afterward, NIV was withdrawn and oxygen was administered by Venturi mask.Both PEEP and inspiratory pressure supportwere adjusted to target a respiratory rate of 25/min and adequate gas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.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Rate of reintubation

The proportion of patients requiring reintubation within 72 hours after extubation

Time frame: Within 72 hours after extubation

Secondary Outcomes

RICU length of stay after extubation

Length of time from extubation to discharging from the RICU

Time frame: From date of extubation until the date of discharging from the RICU up to 28 days

Mortality

Mortality after extubation

Time frame: Within 28 days after extubation

Partial pressure of arterial carbon dioxide

Partial pressure of arterial carbon dioxide tested at the appointed time

Time frame: Within 24 hours before extubation and within 72 hours after extubation