HFNC vs NPPV After Early Extubation for Patients With COPD

High-flow Nasal Cannula Versus Noninvasive Positive Pressure Ventilation Therapy After Early Extubation for Patients With Chronic Obstructive Pulmonary Disease

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.

Study Overview

• Status: Unknown
• Conditions: COPD; Hypercapnic Respiratory Failure
• Intervention / Treatment: Device: HFNC; Device: NPPV

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 Type: Interventional
• Enrollment (Anticipated): 502
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Han Xiaobo, MD; Phone Number: +86 18600310765; Email: hansir510@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100853
      • Recruiting
      • Chinese PLA General Hospital
      • Contact: Cao jiang, MD; Phone Number: +86 010-66937166

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group; NPPV treatment for patients will be performed for patients immediately after extubation in control group.	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.
Experimental: intervention group; HFNC treatment will be performed for patients immediately after extubation in the intervention group.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
reintubation	The primary outcome is reintubation within the 7 days after extubation.	within the 7 days after extubation.

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Chinese PLA General Hospital
• Collaborators: Peking University Health Science Center
• Investigators: Study Chair: XIE Lixin, MD, Chinese PLA General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2019
• Primary Completion (Anticipated): May 1, 2022
• Study Completion (Anticipated): November 1, 2022

Study Registration Dates

• First Submitted: November 1, 2019
• First Submitted That Met QC Criteria: November 5, 2019
• First Posted (Actual): November 7, 2019

Study Record Updates

• Last Update Posted (Actual): January 23, 2020
• Last Update Submitted That Met QC Criteria: January 22, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: COPD; Weaning; NPPV; HFNC; PIC
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: 2018ZX09201013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No