- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03003559
HFNC vs Nasal Cannula in Mild Chronic Obstructive Pulmonary Disease Exacerbation
January 13, 2020 updated by: Qingyuan Zhan, China-Japan Friendship Hospital
Comparison of High Flow Nasal Cannula vs Nasal Cannula in Mild Chronic Obstructive Pulmonary Disease Exacerbation(AECOPD)
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
328
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100028
- Recruiting
- China-Japan Friendship Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: High flow nasal cannula
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.
|
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.
Other Names:
|
NO_INTERVENTION: Nasal cannula
Nasal cannula;set oxygen flow to keep SpO2 90-95%
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
endotracheal intubation demand rate
Time Frame: 90days
|
90days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
actual endotracheal intubation rate
Time Frame: 90days
|
90days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 1, 2017
Primary Completion (ANTICIPATED)
December 1, 2020
Study Completion (ANTICIPATED)
December 1, 2020
Study Registration Dates
First Submitted
December 22, 2016
First Submitted That Met QC Criteria
December 27, 2016
First Posted (ESTIMATE)
December 28, 2016
Study Record Updates
Last Update Posted (ACTUAL)
January 18, 2020
Last Update Submitted That Met QC Criteria
January 13, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016YFC1304304-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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