Effect of Postextubation High-Flow Nasal Cannula vs Noninvasive Ventilation in Patients With Hypercapnic COPD (COPD)
Primary Purpose
High-Flow Nasal Cannula, COPD
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
High-FlowNasal Cannula
Noninvasive Ventilation
Sponsored by
About this trial
This is an interventional treatment trial for High-Flow Nasal Cannula
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of AECOPD
- Extubation must be performed after 48 hours of invasive ventilation
- Must be treated sequentially with HFNC or NIV after extubation
- PaCO2≥50mmHg when extubation
- Positive End Expiratory Pressure (PEEP) ≤8cmH2O (1cmH2O=0.098 kPa) when extubation
Exclusion Criteria:
- Do-not-intubate
- Tracheostomies
- Accidental extubation
- Self-extubation
Sites / Locations
- Xiangya Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
High-Flow Nasal Cannula
Noninvasive Ventilation
Arm Description
High-flow oxygen was applied immediately after extubation through specific nasal cannula.
Noninvasive Ventilation was applied immediately after extubation.
Outcomes
Primary Outcome Measures
Rate of reintubation
The proportion of patients requiring reintubation within 72 hours after extubation
Secondary Outcome Measures
RICU length of stay after extubation
Length of time from extubation to discharging from the RICU
Mortality
Mortality after extubation
Partial pressure of arterial carbon dioxide
Partial pressure of arterial carbon dioxide tested at the appointed time
Full Information
NCT ID
NCT03928535
First Posted
April 13, 2019
Last Updated
April 24, 2019
Sponsor
Xiangya Hospital of Central South University
1. Study Identification
Unique Protocol Identification Number
NCT03928535
Brief Title
Effect of Postextubation High-Flow Nasal Cannula vs Noninvasive Ventilation in Patients With Hypercapnic COPD
Acronym
COPD
Official Title
Effect of Postextubation High-Flow Nasal Cannula vs Noninvasive Ventilation on Reintubation and Postextubation Respiratory Failure in Patients With Hypercapnic COPD,a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2016 (Actual)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xiangya Hospital of Central South University
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
To test if high-flow conditioned oxygen therapy is noninferior to NIV for preventing postextubation respiratory failure and reintubation in patients with hypercapnic COPD, investigators plan to conduct the participants level, 1:1 randomized trial at the respiratory ICU. Participants were randomized to undergo either high-flow conditioned oxygen therapy or noninvasive mechanical ventilation after extubation. Primary outcomes were reintubation and postextubation respiratory failure within 72 hours. Secondary outcomes included length of RICU stay after extubation and mortality; partial pressure of arterial carbon dioxide.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High-Flow Nasal Cannula, COPD
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High-Flow Nasal Cannula
Arm Type
Other
Arm Description
High-flow oxygen was applied immediately after extubation through specific nasal cannula.
Arm Title
Noninvasive Ventilation
Arm Type
Other
Arm Description
Noninvasive Ventilation was applied immediately after extubation.
Intervention Type
Device
Intervention Name(s)
High-FlowNasal Cannula
Intervention Description
High-flowoxygenwas applied immediately after extubation through specific nasal cannula. Flow was initially set at 10 L/min and titrated upwards in 5-L/min steps until patients experienced discomfort.Temperature was initially set to 37°C, unless reported too hot by patients, and FIO2 was regularly adjusted to the target peripheral capillary oxygen saturation (SPO2) of greater than 92%. After 24 hours, high-flow was stopped and, if necessary, patients received conventional oxygen therapy.
Intervention Type
Device
Intervention Name(s)
Noninvasive Ventilation
Intervention Description
Full face mask NIV was continuously delivered immediately after extubation for a scheduled period of 24 hours after extubation. Afterward, NIV was withdrawn and oxygen was administered by Venturi mask.Both PEEP and inspiratory pressure supportwere adjusted to target a respiratory rate of 25/min and adequate gas exchange (arterial oxygen saturation [SaO2] 92%, with pH of 7.35). The FIO2 was adjusted to maintain SPO2 at less than 92%. Sedatives to increase tolerance to NIV were not allowed.
Primary Outcome Measure Information:
Title
Rate of reintubation
Description
The proportion of patients requiring reintubation within 72 hours after extubation
Time Frame
Within 72 hours after extubation
Secondary Outcome Measure Information:
Title
RICU length of stay after extubation
Description
Length of time from extubation to discharging from the RICU
Time Frame
From date of extubation until the date of discharging from the RICU up to 28 days
Title
Mortality
Description
Mortality after extubation
Time Frame
Within 28 days after extubation
Title
Partial pressure of arterial carbon dioxide
Description
Partial pressure of arterial carbon dioxide tested at the appointed time
Time Frame
Within 24 hours before extubation and within 72 hours after extubation
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of AECOPD
Extubation must be performed after 48 hours of invasive ventilation
Must be treated sequentially with HFNC or NIV after extubation
PaCO2≥50mmHg when extubation
Positive End Expiratory Pressure (PEEP) ≤8cmH2O (1cmH2O=0.098 kPa) when extubation
Exclusion Criteria:
Do-not-intubate
Tracheostomies
Accidental extubation
Self-extubation
Facility Information:
Facility Name
Xiangya Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Effect of Postextubation High-Flow Nasal Cannula vs Noninvasive Ventilation in Patients With Hypercapnic COPD
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