Back to resultsThe Physiological Effect of High Flow Oxygen Therapy
Primary Purpose
High-flow Nasal Cannula, Non-invasive Positive Pressure Ventilation, Acute Exacerbation of Chronic Obstructive Pulmonary Disease
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 High-flow Nasal Cannula
Eligibility Criteria
Inclusion Criteria:
- AECOPD patients with acute hypercapnic respiratory failure
Exclusion Criteria:
- other lung/pleural diseases or thoracic deformity
- severe heart failure (New York Heart Association class IV), severe dysrhythmia
- unstable angina, or malignant comorbidity
- obesity (BMI ≥ 35 kg/m²)
- severe obstructive sleep apnea syndrome
Sites / Locations
- The First Affiliated Hospital of Guangzhou Medical University.Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
HFNC group
NPPV group
Arm Description
AECOPD patients receive ventilation support via HFNC.
AECOPD patients receive ventilation support via NPPV.
Outcomes
Primary Outcome Measures
Neural respiratory drive
Neural respiratory drive is calculated by diaphragm electromyogram
Secondary Outcome Measures
Work of breathing
Work of breathing is calculated by the transdiaphragmatic pressure
Transcutaneous CO2
Transcutaneous CO2 is a non-invasive method estimated the partial pressure of arterial blood CO2.
Full Information
NCT ID
NCT04212182
First Posted
December 23, 2019
Last Updated
December 26, 2019
Sponsor
The First Affiliated Hospital of Guangzhou Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04212182
Brief Title
The Physiological Effect of High Flow Oxygen Therapy
Official Title
The Physiological Effect of High Flow Oxygen Therapy on Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 27, 2019 (Actual)
Primary Completion Date
July 1, 2020 (Anticipated)
Study Completion Date
July 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Affiliated Hospital of Guangzhou Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Although non-invasive positive pressure ventilation (NPPV) shows the good curative effect of treating the patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD), some patients do not tolerate NPPV or do not benefit from it. High-flow nasal cannula (HFNC) is well tolerated and may be used to patients with AECOPD who are intolerant to NPPV treatment. This study is to evaluate the physiological effect of HFNC and compare it with NPPV.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High-flow Nasal Cannula, Non-invasive Positive Pressure Ventilation, Acute Exacerbation of Chronic Obstructive Pulmonary Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HFNC group
Arm Type
Experimental
Arm Description
AECOPD patients receive ventilation support via HFNC.
Arm Title
NPPV group
Arm Type
Active Comparator
Arm Description
AECOPD patients receive ventilation support via NPPV.
Intervention Type
Device
Intervention Name(s)
HFNC
Intervention Description
HFNC provides warmed and humidified gas administered through slightly enlarged nasal prongs.
Intervention Type
Device
Intervention Name(s)
NPPV
Intervention Description
NPPV is the standard therapy for ventilatory failure in AECOPD.
Primary Outcome Measure Information:
Title
Neural respiratory drive
Description
Neural respiratory drive is calculated by diaphragm electromyogram
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Work of breathing
Description
Work of breathing is calculated by the transdiaphragmatic pressure
Time Frame
30 minutes
Title
Transcutaneous CO2
Description
Transcutaneous CO2 is a non-invasive method estimated the partial pressure of arterial blood CO2.
Time Frame
30 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
AECOPD patients with acute hypercapnic respiratory failure
Exclusion Criteria:
other lung/pleural diseases or thoracic deformity
severe heart failure (New York Heart Association class IV), severe dysrhythmia
unstable angina, or malignant comorbidity
obesity (BMI ≥ 35 kg/m²)
severe obstructive sleep apnea syndrome
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lili Guan, PhD
Phone
+8613422288665
Email
dr_nickguan@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rongchang Chen, MD
Organizational Affiliation
The First Affiliated Hospital of Guangzhou Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
The First Affiliated Hospital of Guangzhou Medical University.
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lili Guan, PhD
Phone
+8613422288665
Email
dr_nickguan@163.com
12. IPD Sharing Statement
Learn more about this trial
The Physiological Effect of High Flow Oxygen Therapy
We'll reach out to this number within 24 hrs