Application of High Flow Nasal Cannula for Prevention of Post-extubation Atelectasis in Children Undergoing Surgery
Primary Purpose
Atelectasis
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
high flow nasal cannula oxygenation
nasal prong
Sponsored by
About this trial
This is an interventional prevention trial for Atelectasis
Eligibility Criteria
Inclusion Criteria:
- general anesthesia
Exclusion Criteria:
- preterm
- bronchopulmonary dysplasia
- upper respiratory infection history
- respiratory disease
- cardiac surgery
Sites / Locations
- Seoul National University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
nasal prong
high flow nasal cannula oxygenation
Arm Description
conventional nasal prong application after the surgery in postanesthetic care unit (PACU)
high flow nasal cannula application after the surgery in postanesthetic care unit (PACU)
Outcomes
Primary Outcome Measures
lung sound score
0: Normal aeration (N): presence of lung sliding with A lines or fewer than two isolated B lines
Moderate loss of lung aeration: multiple well-defined B lines (B1 lines)
Severe loss of lung aeration: multiple coalescent B lines (B2 lines)
Lung consolidation (C): the presence of a tissue pattern characterized by dynamic air
Secondary Outcome Measures
Full Information
NCT ID
NCT03817177
First Posted
January 23, 2019
Last Updated
March 5, 2019
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03817177
Brief Title
Application of High Flow Nasal Cannula for Prevention of Post-extubation Atelectasis in Children Undergoing Surgery
Official Title
Seoul National University Hospital Department of Anesthesiology and Pain Medicine
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 2, 2019 (Actual)
Primary Completion Date
January 30, 2021 (Anticipated)
Study Completion Date
June 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
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
postoperative atelectasis observation by ultrasound after application of high flow nasal cannula oxygenation
Detailed Description
After surgery, postoperative atelectasis observation by ultrasound grading comparison between application of conventional nasal prong and high flow nasal cannula device
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atelectasis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
nasal prong
Arm Type
Placebo Comparator
Arm Description
conventional nasal prong application after the surgery in postanesthetic care unit (PACU)
Arm Title
high flow nasal cannula oxygenation
Arm Type
Experimental
Arm Description
high flow nasal cannula application after the surgery in postanesthetic care unit (PACU)
Intervention Type
Procedure
Intervention Name(s)
high flow nasal cannula oxygenation
Intervention Description
high flow nasal cannula application in PACU
Intervention Type
Procedure
Intervention Name(s)
nasal prong
Intervention Description
conventional nasal prong application in PACU
Primary Outcome Measure Information:
Title
lung sound score
Description
0: Normal aeration (N): presence of lung sliding with A lines or fewer than two isolated B lines
Moderate loss of lung aeration: multiple well-defined B lines (B1 lines)
Severe loss of lung aeration: multiple coalescent B lines (B2 lines)
Lung consolidation (C): the presence of a tissue pattern characterized by dynamic air
Time Frame
30 minutes after arrival of postanesthetic care unit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
general anesthesia
Exclusion Criteria:
preterm
bronchopulmonary dysplasia
upper respiratory infection history
respiratory disease
cardiac surgery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hee-Soo Kim, MD, Phd
Phone
0220723659
Email
dami0605@snu.ac.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Ji-Hyun Lee, MD, PHd
Phone
0220723664
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hee-Soo Kim
Organizational Affiliation
Seoul National University Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heesoo Kim
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33181560
Citation
Lee JH, Ji SH, Jang YE, Kim EH, Kim JT, Kim HS. Application of a High-Flow Nasal Cannula for Prevention of Postextubation Atelectasis in Children Undergoing Surgery: A Randomized Controlled Trial. Anesth Analg. 2021 Aug 1;133(2):474-482. doi: 10.1213/ANE.0000000000005285.
Results Reference
derived
Learn more about this trial
Application of High Flow Nasal Cannula for Prevention of Post-extubation Atelectasis in Children Undergoing Surgery
We'll reach out to this number within 24 hrs