HFNC vs Nasal Cannula in Mild Chronic Obstructive Pulmonary Disease Exacerbation
Primary Purpose
COPD Exacerbation
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
High flow nasal cannula
Sponsored by
About this trial
This is an interventional treatment trial for COPD Exacerbation focused on measuring COPD Exacerbation, High Flow Oxygen, Nasal Cannula, mild
Eligibility Criteria
Inclusion Criteria:
- AECOPD; pH≥7.35, PaCO2>45 mmHg
Exclusion Criteria:
- Need to be intubated immediately; refuse to engage in the study; severe organ dysfunction
Sites / Locations
- China-Japan Friendship hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
High flow nasal cannula
Nasal cannula
Arm Description
High flow nasal cannula(OptiflowTM); Flow 25-60 L/min is set according to patients' comfort; FiO2 is adjusted to maintain peripheral capillary oxygen saturation(SpO2) 90-95%; temperature is set at 37.
Nasal cannula;set oxygen flow to keep SpO2 90-95%
Outcomes
Primary Outcome Measures
endotracheal intubation demand rate
Secondary Outcome Measures
actual endotracheal intubation rate
Full Information
NCT ID
NCT03003559
First Posted
December 22, 2016
Last Updated
January 13, 2020
Sponsor
China-Japan Friendship Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03003559
Brief Title
HFNC vs Nasal Cannula in Mild Chronic Obstructive Pulmonary Disease Exacerbation
Official Title
Comparison of High Flow Nasal Cannula vs Nasal Cannula in Mild Chronic Obstructive Pulmonary Disease Exacerbation(AECOPD)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 2017 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China-Japan Friendship Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
For AECOPD patients, only 8% patients ventilated by noninvasive and invasive positive pressure ventilation. Nasal cannula is the most common pattern of oxygen therapy in mild AECOPD. As a low flow oxygen therapy, nasal cannula has many disadvantages.Therefore, we design a randomized controlled trial(RCT)to explore whether HFNC would be better than nasal cannula to prevent the aggravation of respiratory failure and endotracheal intubation in mild AECOPD.
Detailed Description
For AECOPD patients, most of patients don't need respiratory support, only 8% patients ventilated by noninvasive and invasive positive pressure ventilation. Nasal cannula is the most common pattern of oxygen therapy in mild AECOPD. As a low flow oxygen therapy, nasal cannula has many disadvantages: discomfort, low humidity and unstable fraction of inspired oxygen(FiO2) in inspiratory gas. Therefore, we design a RCT to explore whether HFNC would be better than nasal cannula to prevent the aggravation of respiratory failure and endotracheal intubation in mild AECOPD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD Exacerbation
Keywords
COPD Exacerbation, High Flow Oxygen, Nasal Cannula, mild
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
328 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
High flow nasal cannula
Arm Type
Experimental
Arm Description
High flow nasal cannula(OptiflowTM); Flow 25-60 L/min is set according to patients' comfort; FiO2 is adjusted to maintain peripheral capillary oxygen saturation(SpO2) 90-95%; temperature is set at 37.
Arm Title
Nasal cannula
Arm Type
No Intervention
Arm Description
Nasal cannula;set oxygen flow to keep SpO2 90-95%
Intervention Type
Device
Intervention Name(s)
High flow nasal cannula
Other Intervention Name(s)
High flow oxygen
Intervention Description
High flow nasal cannula (HFNC) is a new emerging noninvasive respiratory support technology, which mainly includes high flow (15-60 L/min) device, heating humidification device and nasal cannula for high flow. A large number of physiological studies confirmed that HFNC has the following critical physiological effects: promoting airway humidification, improving tolerance of treatment, reducing the physiological dead space on the upper respiratory tract, producing a certain level of positive end expiratory pressure (2-7 cmH2O), decreasing the work of breathing and so on.
Primary Outcome Measure Information:
Title
endotracheal intubation demand rate
Time Frame
90days
Secondary Outcome Measure Information:
Title
actual endotracheal intubation rate
Time Frame
90days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
AECOPD; pH≥7.35, PaCO2>45 mmHg
Exclusion Criteria:
Need to be intubated immediately; refuse to engage in the study; severe organ dysfunction
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jingen Xia, Master
Phone
13466396561
Ext
+86
Email
xiajingen_00632@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qingyuan Zhan, M.D.
Organizational Affiliation
China-Japan Friendship Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
China-Japan Friendship hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100028
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chen Wang, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35428349
Citation
Xia J, Gu S, Lei W, Zhang J, Wei H, Liu C, Zhang H, Lu R, Zhang L, Jiang M, Hu C, Cheng Z, Wei C, Chen Y, Lu F, Chen M, Bi H, Liu H, Yan C, Teng H, Yang Y, Liang C, Ge Y, Hou P, Liu J, Gao W, Zhang Y, Feng Y, Tao C, Huang X, Pan P, Luo H, Yun C, Zhan Q. High-flow nasal cannula versus conventional oxygen therapy in acute COPD exacerbation with mild hypercapnia: a multicenter randomized controlled trial. Crit Care. 2022 Apr 15;26(1):109. doi: 10.1186/s13054-022-03973-7.
Results Reference
derived
Learn more about this trial
HFNC vs Nasal Cannula in Mild Chronic Obstructive Pulmonary Disease Exacerbation
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