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NCT04868266 Clinical Trial

End Tidal Carbon Dioxide in Minimal Sedation

Complication of Anesthesia Clinical Trial

— ETCO2  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04868266
Other study ID # D-2103-187-1208
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 7, 2021
Est. completion date April 30, 2024

Study information
Verified date July 2021
Source Seoul National University Hospital
Contact Jin-Tae Kim, professor
Phone +82-2-2072-3664
Email jintae73@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 206
Est. completion date April 30, 2024
Est. primary completion date April 30, 2024
Accepts healthy volunteers No
Gender All
Age group N/A to 18 Years
Eligibility Inclusion Criteria: - pediatric patients undergoing minimal sedation for procedure. Exclusion Criteria: - none

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• end tidal carbon dioxide monitoring
We will monitor end tidal carbon dioxide with capnography during minimal sedation

Locations
Country Name City State
Korea, Republic of Jin-Tae Kim Seoul

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of oxygen desaturation oxygen saturation lower than 95% from immediately after sedation to end of procedure, up to 2 hours
Secondary number of Staff intervetions 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 from immediately after sedation to end of procedure, up to 2 hours
Secondary Severe oxygen desaturation oxygen saturation lower than 85%, 90% from immediately after sedation to end of procedure, up to 2 hours
Secondary Lowest oxygen saturation value of oxygen saturation from immediately after sedation to end of procedure, up to 2 hours
Secondary Episode of apnea capnography flat line more than 5 seconds from immediately after sedation to end of procedure, up to 2 hours
Secondary sedation level 6-point pediatric sedation state scale from immediately after sedation to end of procedure, up to 2 hours
Secondary inappropriate monitoring the duration of inappropriate capnography monitoring from immediately after sedation to end of procedure, up to 2 hours
Secondary Airway obstruction stridor, retraction from immediately after sedation to end of procedure, up to 2 hours
Secondary Integrated pulmonary index calculated parameter from immediately after sedation to end of procedure, up to 2 hours
Secondary success of procedure success or fail of sedation or procedure from immediately after sedation to end of procedure, up to 2 hours
Secondary Hemodynamic instability heart rate and blood pressure change more than 20% from immediately after sedation to end of procedure, up to 2 hours
Secondary Medication type and dosage of sedatives from immediately after sedation to end of procedure, up to 2 hours
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