Application of High Flow Nasal Cannula for Prevention of Post-extubation Atelectasis in Children Undergoing Surgery
March 5, 2019 updated by: Hee-Soo Kim, Seoul National University Hospital
Seoul National University Hospital Department of Anesthesiology and Pain Medicine
postoperative atelectasis observation by ultrasound after application of high flow nasal cannula oxygenation
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
After surgery, postoperative atelectasis observation by ultrasound grading comparison between application of conventional nasal prong and high flow nasal cannula device
Study Type
Interventional
Enrollment (Anticipated)
80
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
-
-
-
Seoul, Korea, Republic of
- Recruiting
- Seoul National University 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
1 day to 2 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- general anesthesia
Exclusion Criteria:
- preterm
- bronchopulmonary dysplasia
- upper respiratory infection history
- respiratory disease
- cardiac surgery
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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: nasal prong
conventional nasal prong application after the surgery in postanesthetic care unit (PACU)
|
conventional nasal prong application in PACU
|
|
Experimental: high flow nasal cannula oxygenation
high flow nasal cannula application after the surgery in postanesthetic care unit (PACU)
|
high flow nasal cannula application in PACU
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
lung sound score
Time Frame: 30 minutes after arrival of postanesthetic care unit
|
0: Normal aeration (N): presence of lung sliding with A lines or fewer than two isolated B lines
|
30 minutes after arrival of postanesthetic care unit
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Hee-Soo Kim, Seoul National University Children's Hospital
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)
March 2, 2019
Primary Completion (Anticipated)
January 30, 2021
Study Completion (Anticipated)
June 30, 2021
Study Registration Dates
First Submitted
January 23, 2019
First Submitted That Met QC Criteria
January 23, 2019
First Posted (Actual)
January 25, 2019
Study Record Updates
Last Update Posted (Actual)
March 7, 2019
Last Update Submitted That Met QC Criteria
March 5, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1812-111-998
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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.