End Tidal Carbon Dioxide in Minimal Sedation

Not Applicable

Active, not recruiting

• Conditions: Complication of Anesthesia
• Interventions: Other: end tidal carbon dioxide monitoring

• 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

Study Timeline

• Study First Submitted: 2021-04-25
• Study First Submitted QC: 2021-04-27
• Study First Posted: 2021-04-30
• Study Start: 2021-07-07
• Primary Completion: 2024-04-30
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-29
• Last Update Posted: 2024-05-31
• Study Completion: 2024-12-30

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

Arm && Interventions

Group	Intervention	Description
end tidal carbon dioxide monitoring	end tidal carbon dioxide monitoring	-

Primary Outcome Measures

Name	Time	Method
Incidence of oxygen desaturation	from immediately after sedation to end of procedure, up to 2 hours	oxygen saturation lower than 95%

Secondary Outcome Measures

Name	Time	Method
number of Staff intervetions	from 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 desaturation	from immediately after sedation to end of procedure, up to 2 hours	oxygen saturation lower than 85%, 90%
Lowest oxygen saturation	from immediately after sedation to end of procedure, up to 2 hours	value of oxygen saturation
Integrated pulmonary index	from immediately after sedation to end of procedure, up to 2 hours	calculated parameter
success of procedure	from immediately after sedation to end of procedure, up to 2 hours	success or fail of sedation or procedure
Hemodynamic instability	from immediately after sedation to end of procedure, up to 2 hours	heart rate and blood pressure change more than 20%
Episode of apnea	from immediately after sedation to end of procedure, up to 2 hours	capnography flat line more than 5 seconds
sedation level	from immediately after sedation to end of procedure, up to 2 hours	6-point pediatric sedation state scale
Airway obstruction	from immediately after sedation to end of procedure, up to 2 hours	stridor, retraction
Medication	from immediately after sedation to end of procedure, up to 2 hours	type and dosage of sedatives
inappropriate monitoring	from immediately after sedation to end of procedure, up to 2 hours	the duration of inappropriate capnography monitoring

Trial Locations

Locations (1)

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