HFNC vs NPPV After Early Extubation for Patients With COPD

NCT ID: NCT04156139

Last Updated: 2020-01-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 502 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-18
• Study Completion Date: 2022-11-01

Brief 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.

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.

Conditions

COPD; Hypercapnic Respiratory Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control group

NPPV treatment for patients will be performed for patients immediately after extubation in control group.

Group Type: ACTIVE_COMPARATOR

HFNC

Intervention Type: DEVICE

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

Intervention Type: DEVICE

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.

intervention group

HFNC treatment will be performed for patients immediately after extubation in the intervention group.

Group Type: EXPERIMENTAL

HFNC

Intervention Type: DEVICE

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

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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;

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University Health Science Center

OTHER

Sponsor Role: collaborator

Chinese PLA General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Lixin Xie

Director of Department of Respiratory and Critical Care Medicine, Chinese PLA General Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

XIE Lixin, MD

Role: STUDY_CHAIR

Chinese PLA General Hospital

Locations

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Han Xiaobo, MD

Role: CONTACT

hansir510@163.com

+86 18600310765

Facility Contacts

Cao jiang, MD

Role: primary

+86 010-66937166

Other Identifiers

2018ZX09201013

Identifier Type: -

Identifier Source: org_study_id