HFNC vs NPPV After Early Extubation for Patients With COPD

Overview

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.

Full Title of Study: “High-flow Nasal Cannula Versus Noninvasive Positive Pressure Ventilation Therapy After Early Extubation for Patients With Chronic Obstructive Pulmonary Disease”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 1, 2022

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.

Interventions

  • Device: HFNC
    • 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.
  • Device: NPPV
    • 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.

Arms, Groups and Cohorts

  • Active Comparator: Control group
    • NPPV treatment for patients will be performed for patients immediately after extubation in control group.
  • Experimental: intervention group
    • HFNC treatment will be performed for patients immediately after extubation in the intervention group.

Clinical Trial Outcome Measures

Primary Measures

  • reintubation
    • Time Frame: within the 7 days after extubation.
    • The primary outcome is reintubation within the 7 days after extubation.

Secondary Measures

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

Participating in This Clinical Trial

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;

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Chinese PLA General Hospital
  • Collaborator
    • Peking University Health Science Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Lixin Xie, Director of Department of Respiratory and Critical Care Medicine, Chinese PLA General Hospital – Chinese PLA General Hospital
  • Overall Official(s)
    • XIE Lixin, MD, Study Chair, Chinese PLA General Hospital
  • Overall Contact(s)
    • Han Xiaobo, MD, +86 18600310765, hansir510@163.com

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