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
1 other identifier
interventional
502
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 1, 2019
CompletedFirst Posted
Study publicly available on registry
November 7, 2019
CompletedStudy Start
First participant enrolled
December 18, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2022
CompletedJanuary 23, 2020
January 1, 2020
2.4 years
November 1, 2019
January 22, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
reintubation
The primary outcome is reintubation within the 7 days after extubation.
within the 7 days after extubation.
Secondary Outcomes (1)
Weaning failure
within the7 days after extubation
Study Arms (2)
Control group
ACTIVE COMPARATORNPPV treatment for patients will be performed for patients immediately after extubation in control group.
intervention group
EXPERIMENTALHFNC treatment will be performed for patients immediately after extubation in the intervention group.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- \. 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
You may not qualify if:
- Severe organ dysfunction;Myopathy or myasthenia gravis;Upper airway obstruction;A large amount of secretions and inability to drain;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
XIE Lixin, MD
Chinese PLA General Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Department of Respiratory and Critical Care Medicine, Chinese PLA General Hospital
Study Record Dates
First Submitted
November 1, 2019
First Posted
November 7, 2019
Study Start
December 18, 2019
Primary Completion
May 1, 2022
Study Completion
November 1, 2022
Last Updated
January 23, 2020
Record last verified: 2020-01
Data Sharing
- IPD Sharing
- Will not share