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Clinical Trials/NCT04868266
NCT04868266Active, not recruitingNot Applicable

A Randomized Controlled Trial of the Effect of Capnography for Preventing Hypoxia in Minimally Sedated Pediatric Patients

Seoul National University Hospital1 site in 1 country214 target enrollmentStarted: July 7, 2021Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
214
Locations
1
Primary Endpoint
Incidence of oxygen desaturation
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
— to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •pediatric patients undergoing minimal sedation for procedure.

Exclusion Criteria

  • Not provided

Arms & Interventions

end tidal carbon dioxide monitoring

Experimental

Intervention: end tidal carbon dioxide monitoring (Other)

Oxygen saturation monitoring

No Intervention

Outcomes

Primary Outcomes

Incidence of oxygen desaturation

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

oxygen saturation lower than 95%

Secondary Outcomes

  • 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)
  • Integrated pulmonary index(from immediately after sedation to end of procedure, up to 2 hours)
  • success of procedure(from immediately after sedation to end of procedure, up to 2 hours)
  • Hemodynamic instability(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)
  • Airway obstruction(from immediately after sedation to end of procedure, up to 2 hours)
  • Medication(from immediately after sedation to end of procedure, up to 2 hours)
  • inappropriate monitoring(from immediately after sedation to end of procedure, up to 2 hours)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jin-Tae Kim

professor

Seoul National University Hospital

Study Sites (1)

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