NCT04868266

Brief Summary

This randomized controlled study investigated the effect of end-tidal carbon dioxide monitoring in pediatric patients undergoing minimal sedation.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
214

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

April 25, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 30, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

July 7, 2021

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

May 31, 2024

Status Verified

May 1, 2024

Enrollment Period

2.8 years

First QC Date

April 25, 2021

Last Update Submit

May 29, 2024

Conditions

Complication of Anesthesia

Outcome Measures

Primary Outcomes (1)

  • Incidence of oxygen desaturation

    oxygen saturation lower than 95%

    from immediately after sedation to end of procedure, up to 2 hours

Secondary Outcomes (11)

  • number of Staff intervetions

    from immediately after sedation to end of procedure, up to 2 hours

  • Severe oxygen desaturation

    from immediately after sedation to end of procedure, up to 2 hours

  • Lowest oxygen saturation

    from immediately after sedation to end of procedure, up to 2 hours

  • Episode of apnea

    from immediately after sedation to end of procedure, up to 2 hours

  • sedation level

    from immediately after sedation to end of procedure, up to 2 hours

  • +6 more secondary outcomes

Study Arms (2)

end tidal carbon dioxide monitoring

EXPERIMENTAL
Other: end tidal carbon dioxide monitoring

Oxygen saturation monitoring

NO INTERVENTION

Interventions

end tidal carbon dioxide monitoringOTHER

We will monitor end tidal carbon dioxide with capnography during minimal sedation

end tidal carbon dioxide monitoring

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • pediatric patients undergoing minimal sedation for procedure.

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jin-Tae Kim

Seoul, South Korea

Location

Related Publications (1)

  • Kim EH, Park JB, Ji SH, Jang YE, Lee JH, Kim HS, Kim JT. Using capnography in children to prevent oxygen desaturation during procedural sedation: A randomised trial. Eur J Anaesthesiol. 2025 Nov 1;42(11):1034-1041. doi: 10.1097/EJA.0000000000002250. Epub 2025 Aug 11.

    PMID: 40810300DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

April 25, 2021

First Posted

April 30, 2021

Study Start

July 7, 2021

Primary Completion

April 30, 2024

Study Completion

December 30, 2024

Last Updated

May 31, 2024

Record last verified: 2024-05

Locations

KR(1)