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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
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atelectasis

Eligibility Criteria

1 Day - 2 Years (Child)All SexesDoes not accept healthy volunteers

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

First Posted
January 23, 2019
Last Updated
March 5, 2019
Sponsor
Seoul National University Hospital
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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

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