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Effect of Spontaneous Breathing on Atelectasis During Induction of General Anesthesia in Patients in Infants

Primary Purpose

Atelectasis

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
spontaneous breathing
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 Month - 12 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • general anesthesia

Exclusion Criteria:

  • heart or lung problems
  • prematurity

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

spontaneous breathing

mechanical ventilation

Arm Description

spontaneous breathing after adminitration of anesthetics

mechanical ventilation after adminitration of anesthetics and neuromuscula blockade

Outcomes

Primary Outcome Measures

occurrence of atelectasis
ateletasis grada (> 2)

Secondary Outcome Measures

Full Information

First Posted
November 9, 2018
Last Updated
April 13, 2020
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03739697
Brief Title
Effect of Spontaneous Breathing on Atelectasis During Induction of General Anesthesia in Patients in Infants
Official Title
Seoul National University Children's Hospital
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
December 16, 2019 (Actual)
Study Completion Date
December 16, 2019 (Actual)

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
spontaneous breathing on occurrence of atelectsis in infants
Detailed Description
Keeping the spontaneous breathing during the anesthesia for 5 minutes and occurrence of atelectasis

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
Investigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
spontaneous breathing
Arm Type
Active Comparator
Arm Description
spontaneous breathing after adminitration of anesthetics
Arm Title
mechanical ventilation
Arm Type
No Intervention
Arm Description
mechanical ventilation after adminitration of anesthetics and neuromuscula blockade
Intervention Type
Other
Intervention Name(s)
spontaneous breathing
Intervention Description
spontaneous breathing during induction of anesthesia in infants
Primary Outcome Measure Information:
Title
occurrence of atelectasis
Description
ateletasis grada (> 2)
Time Frame
5 minutes after administration of anesthetics

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: general anesthesia Exclusion Criteria: heart or lung problems prematurity
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hee-Soo Kim
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33009186
Citation
Ji SH, Jang HS, Jang YE, Kim EH, Lee JH, Kim JT, Kim HS. Effect of spontaneous breathing on atelectasis during induction of general anaesthesia in infants: A prospective randomised controlled trial. Eur J Anaesthesiol. 2020 Dec;37(12):1150-1156. doi: 10.1097/EJA.0000000000001327.
Results Reference
derived

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Effect of Spontaneous Breathing on Atelectasis During Induction of General Anesthesia in Patients in Infants

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