NCT03739697

Brief Summary

spontaneous breathing on occurrence of atelectsis in infants

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 9, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 14, 2018

Completed
17 days until next milestone

Study Start

First participant enrolled

December 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 16, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2019

Completed
Last Updated

April 14, 2020

Status Verified

April 1, 2020

Enrollment Period

1 year

First QC Date

November 9, 2018

Last Update Submit

April 13, 2020

Conditions

Atelectasis

Outcome Measures

Primary Outcomes (1)

  • occurrence of atelectasis

    ateletasis grada (\> 2)

    5 minutes after administration of anesthetics

Study Arms (2)

spontaneous breathing

ACTIVE COMPARATOR

spontaneous breathing after adminitration of anesthetics

Other: spontaneous breathing

mechanical ventilation

NO INTERVENTION

mechanical ventilation after adminitration of anesthetics and neuromuscula blockade

Interventions

spontaneous breathingOTHER

spontaneous breathing during induction of anesthesia in infants

spontaneous breathing

Eligibility Criteria

Age1 Month - 12 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • general anesthesia

You may not qualify if:

  • heart or lung problems
  • prematurity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 33009186DERIVED

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Study Officials

  • Hee-Soo Kim

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 9, 2018

First Posted

November 14, 2018

Study Start

December 1, 2018

Primary Completion

December 16, 2019

Study Completion

December 16, 2019

Last Updated

April 14, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)