MedPath

End Tidal Carbon Dioxide in Minimal Sedation

Not Applicable
Active, not recruiting
Conditions
Complication of Anesthesia
Registration Number
NCT04868266
Lead Sponsor
Seoul National University Hospital
Brief Summary

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

Detailed Description

Not available

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
214
Inclusion Criteria
  • pediatric patients undergoing minimal sedation for procedure.
Exclusion Criteria
  • none

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Incidence of oxygen desaturationfrom immediately after sedation to end of procedure, up to 2 hours

oxygen saturation lower than 95%

Secondary Outcome Measures
NameTimeMethod
number of Staff intervetionsfrom immediately after sedation to end of procedure, up to 2 hours

tactile stimulation, jaw thrust or head tilt, suction, oral or nasopharyngeal airway insertion, oxygen supply, laryngeal mask airway insertion, bag-valve mask ventilation, endotracheal intubation

Severe oxygen desaturationfrom immediately after sedation to end of procedure, up to 2 hours

oxygen saturation lower than 85%, 90%

Lowest oxygen saturationfrom immediately after sedation to end of procedure, up to 2 hours

value of oxygen saturation

Integrated pulmonary indexfrom immediately after sedation to end of procedure, up to 2 hours

calculated parameter

success of procedurefrom immediately after sedation to end of procedure, up to 2 hours

success or fail of sedation or procedure

Hemodynamic instabilityfrom immediately after sedation to end of procedure, up to 2 hours

heart rate and blood pressure change more than 20%

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

6-point pediatric sedation state scale

Airway obstructionfrom immediately after sedation to end of procedure, up to 2 hours

stridor, retraction

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

type and dosage of sedatives

inappropriate monitoringfrom immediately after sedation to end of procedure, up to 2 hours

the duration of inappropriate capnography monitoring

Episode of apneafrom immediately after sedation to end of procedure, up to 2 hours

capnography flat line more than 5 seconds

Trial Locations

Locations (1)

Jin-Tae Kim

🇰🇷

Seoul, Korea, Republic of

Jin-Tae Kim
🇰🇷Seoul, Korea, Republic of

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.