HFNC vs NPPV After Early Extubation for Patients With COPD

COPD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04156139
• Other study ID #: 2018ZX09201013
• Status: Recruiting
• Phase: N/A
• Start date: December 18, 2019
• Est. completion date: November 1, 2022

Study information

• Verified date: January 2020
• Source: Chinese PLA General Hospital
• Contact: Han Xiaobo, MD
• Phone: +86 18600310765
• Email: hansir510[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 502
• Est. completion date: November 1, 2022
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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;

Related Conditions & MeSH terms

• COPD
• Hypercapnic Respiratory Failure
• Respiratory Insufficiency

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Chinese PLA General Hospital	Peking University Health Science Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	reintubation	The primary outcome is reintubation within the 7 days after extubation.	within the 7 days after extubation.
Secondary	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