Back to resultsHFNC vs NPPV After Early Extubation for Patients With COPD
Primary Purpose
COPD, Hypercapnic Respiratory Failure
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
HFNC
NPPV
Sponsored by
About this trial
This is an interventional treatment trial for COPD focused on measuring NPPV, HFNC, Weaning, COPD, PIC
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;
Sites / Locations
- Chinese PLA General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control group
intervention group
Arm Description
NPPV treatment for patients will be performed for patients immediately after extubation in control group.
HFNC treatment will be performed for patients immediately after extubation in the intervention group.
Outcomes
Primary Outcome Measures
reintubation
The primary outcome is reintubation within the 7 days after extubation.
Secondary Outcome Measures
Weaning failure
Secondary Outcome is a composite criterion including reintubation events or all-cause deaths within the7 days after extubation
Full Information
NCT ID
NCT04156139
First Posted
November 1, 2019
Last Updated
January 22, 2020
Sponsor
Chinese PLA General Hospital
Collaborators
Peking University Health Science Center
1. Study Identification
Unique Protocol Identification Number
NCT04156139
Brief Title
HFNC vs NPPV After Early Extubation for Patients With COPD
Official Title
High-flow Nasal Cannula Versus Noninvasive Positive Pressure Ventilation Therapy After Early Extubation for Patients With Chronic Obstructive Pulmonary Disease
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 18, 2019 (Actual)
Primary Completion Date
May 1, 2022 (Anticipated)
Study Completion Date
November 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese PLA General Hospital
Collaborators
Peking University Health Science Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD, Hypercapnic Respiratory Failure
Keywords
NPPV, HFNC, Weaning, COPD, PIC
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
502 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
NPPV treatment for patients will be performed for patients immediately after extubation in control group.
Arm Title
intervention group
Arm Type
Experimental
Arm Description
HFNC treatment will be performed for patients immediately after extubation in the intervention group.
Intervention Type
Device
Intervention Name(s)
HFNC
Intervention Description
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
Intervention Name(s)
NPPV
Intervention Description
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.
Primary Outcome Measure Information:
Title
reintubation
Description
The primary outcome is reintubation within the 7 days after extubation.
Time Frame
within the 7 days after extubation.
Secondary Outcome Measure Information:
Title
Weaning failure
Description
Secondary Outcome is a composite criterion including reintubation events or all-cause deaths within the7 days after extubation
Time Frame
within the7 days after extubation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Han Xiaobo, MD
Phone
+86 18600310765
Email
hansir510@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
XIE Lixin, MD
Organizational Affiliation
Chinese PLA General Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Chinese PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cao jiang, MD
Phone
+86 010-66937166
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
HFNC vs NPPV After Early Extubation for Patients With COPD
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