The Edi Level and Cardiopulmonary Function Between HHHFNC and Unheated Humidified High-Flow Oxygen Mask in COPD
Primary Purpose
Chronic Obstructive Lung Disease, Respiratory Insufficiency
Status
Terminated
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
HHHFNC
UHFOM
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Lung Disease
Eligibility Criteria
Inclusion Criteria:
- AE of COPD received intubation and ready to be weaning
- P/F ratio > 200 during SBT before extubation
Exclusion Criteria:
- Unable to insert NG tube
- Refuse to re-intubated when respiratory failure after extubation
- Planned NIV use after extubation
- Pregnancy
Sites / Locations
- Fu Jen Catholic University Hospital, Fu Jen Catholic University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
HHHFNC group
UHFOM group
Arm Description
On HHHFNC FiO2 will setting as same as SBT before extubation Flow rate: 50L/min
On Aerosol mask FiO2 will setting as same as SBT before extubation Flow rate: 15L/min
Outcomes
Primary Outcome Measures
Diaphragm electrical activity
In voltage
Secondary Outcome Measures
PtcO2 & PtcCO2
In mmHg
Re-intubation rate
In %
Cardiac index
In L/min/m2
Hospital stay
In days
ICU stay
In days
Full Information
NCT ID
NCT03811158
First Posted
January 14, 2019
Last Updated
October 25, 2022
Sponsor
Fu Jen Catholic University
1. Study Identification
Unique Protocol Identification Number
NCT03811158
Brief Title
The Edi Level and Cardiopulmonary Function Between HHHFNC and Unheated Humidified High-Flow Oxygen Mask in COPD
Official Title
The Diaphragm Activity Level and Cardiopulmonary Function Between Heated Humidified High-Flow Nasal Cannula and Unheated Humidified High-Flow Oxygen Mask in Acute Exacerbation of COPD Patients as Post-Extubation Respiratory Support
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Terminated
Why Stopped
Difficult to recruit participants
Study Start Date
May 21, 2018 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
July 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fu Jen Catholic University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Patients with COPD exacerbation usually need respiratory support after extubation. Recently, HHHFNC has been used in both adult and neonates with post-extubation respiratory support. Studies indicate that HHHFNC has seminar efficacy compared to non-invasive positive pressure ventilation and superior than conventional oxygen therapy. There are no clinical data of diaphragm electrical activity and cardiopulmonary function for using HHHFNC and UHFOM as post-extubation respiratory support.
Detailed Description
Objectives: The aim of this study is to compare the Edi level and cardiopulmonary parameters between heated humidified high-flow nasal cannula (HHHFNC) versus unheated high-flow oxygen mask (UHFOM) in acute exacerbation of chronic obstructive pulmonary disease (COPD) patients with post-extubation respiratory support. This is the first clinical trial to investigate and analysis the variations of cardiopulmonary parameters and Edi level between HHHFNC and UHFOM in adult patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Lung Disease, Respiratory Insufficiency
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Patents with COPD exacerbation who were intubated for respiratory failure will all enrolled to this study. Participants will be studied on 2 consecutive days and random assigned with crossover. The primary outcome measure is the diaphragm electrical activity. The secondary outcome measures include the cardiopulmonary function, length of hospital stay, and re-intubation rate.
Masking
Investigator
Masking Description
All data will be decoded before biostatics analysis
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HHHFNC group
Arm Type
Experimental
Arm Description
On HHHFNC FiO2 will setting as same as SBT before extubation Flow rate: 50L/min
Arm Title
UHFOM group
Arm Type
Sham Comparator
Arm Description
On Aerosol mask FiO2 will setting as same as SBT before extubation Flow rate: 15L/min
Intervention Type
Device
Intervention Name(s)
HHHFNC
Other Intervention Name(s)
Study group
Intervention Description
Prospective, randomized crossover control trial, single ICU. Patents with COPD exacerbation who were intubated for respiratory failure will all enrolled to this study. Participants will be studied on 2 consecutive days and random assigned with crossover.
Intervention Type
Device
Intervention Name(s)
UHFOM
Other Intervention Name(s)
Control group
Intervention Description
Prospective, randomized crossover control trial, single ICU. Patents with COPD exacerbation who were intubated for respiratory failure will all enrolled to this study. Participants will be studied on 2 consecutive days and random assigned with crossover.
Primary Outcome Measure Information:
Title
Diaphragm electrical activity
Description
In voltage
Time Frame
2 days
Secondary Outcome Measure Information:
Title
PtcO2 & PtcCO2
Description
In mmHg
Time Frame
2 days
Title
Re-intubation rate
Description
In %
Time Frame
2 days
Title
Cardiac index
Description
In L/min/m2
Time Frame
2 days
Title
Hospital stay
Description
In days
Time Frame
through study completion, an average 3 months
Title
ICU stay
Description
In days
Time Frame
through study completion, an average 1 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
AE of COPD received intubation and ready to be weaning
P/F ratio > 200 during SBT before extubation
Exclusion Criteria:
Unable to insert NG tube
Refuse to re-intubated when respiratory failure after extubation
Planned NIV use after extubation
Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ke-Yun Chao, M.Sc
Organizational Affiliation
ck_qq@hotmail.com
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fu Jen Catholic University Hospital, Fu Jen Catholic University
City
New Taipei City
ZIP/Postal Code
24352
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25558703
Citation
Brotfain E, Zlotnik A, Schwartz A, Frenkel A, Koyfman L, Gruenbaum SE, Klein M. Comparison of the effectiveness of high flow nasal oxygen cannula vs. standard non-rebreather oxygen face mask in post-extubation intensive care unit patients. Isr Med Assoc J. 2014 Nov;16(11):718-22.
Results Reference
result
PubMed Identifier
25980660
Citation
Stephan F, Barrucand B, Petit P, Rezaiguia-Delclaux S, Medard A, Delannoy B, Cosserant B, Flicoteaux G, Imbert A, Pilorge C, Berard L; BiPOP Study Group. High-Flow Nasal Oxygen vs Noninvasive Positive Airway Pressure in Hypoxemic Patients After Cardiothoracic Surgery: A Randomized Clinical Trial. JAMA. 2015 Jun 16;313(23):2331-9. doi: 10.1001/jama.2015.5213.
Results Reference
result
PubMed Identifier
27771739
Citation
Futier E, Paugam-Burtz C, Godet T, Khoy-Ear L, Rozencwajg S, Delay JM, Verzilli D, Dupuis J, Chanques G, Bazin JE, Constantin JM, Pereira B, Jaber S; OPERA study investigators. Effect of early postextubation high-flow nasal cannula vs conventional oxygen therapy on hypoxaemia in patients after major abdominal surgery: a French multicentre randomised controlled trial (OPERA). Intensive Care Med. 2016 Dec;42(12):1888-1898. doi: 10.1007/s00134-016-4594-y. Epub 2016 Oct 22.
Results Reference
result
Learn more about this trial
The Edi Level and Cardiopulmonary Function Between HHHFNC and Unheated Humidified High-Flow Oxygen Mask in COPD
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