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End Tidal Carbon Dioxide in Minimal Sedation

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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04868266
Acronym
ETCO2
Enrollment
214
Registered
2021-04-30
Start date
2021-07-07
Completion date
2024-12-30
Last updated
2024-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complication of Anesthesia

Brief summary

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

Interventions

OTHERend tidal carbon dioxide monitoring

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

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No

Inclusion criteria

* pediatric patients undergoing minimal sedation for procedure.

Exclusion criteria

* none

Design outcomes

Primary

MeasureTime frameDescription
Incidence of oxygen desaturationfrom immediately after sedation to end of procedure, up to 2 hoursoxygen saturation lower than 95%

Secondary

MeasureTime frameDescription
Severe oxygen desaturationfrom immediately after sedation to end of procedure, up to 2 hoursoxygen saturation lower than 85%, 90%
Lowest oxygen saturationfrom immediately after sedation to end of procedure, up to 2 hoursvalue of oxygen saturation
Episode of apneafrom immediately after sedation to end of procedure, up to 2 hourscapnography flat line more than 5 seconds
sedation levelfrom immediately after sedation to end of procedure, up to 2 hours6-point pediatric sedation state scale
inappropriate monitoringfrom immediately after sedation to end of procedure, up to 2 hoursthe duration of inappropriate capnography monitoring
number of Staff intervetionsfrom immediately after sedation to end of procedure, up to 2 hourstactile stimulation, jaw thrust or head tilt, suction, oral or nasopharyngeal airway insertion, oxygen supply, laryngeal mask airway insertion, bag-valve mask ventilation, endotracheal intubation
Integrated pulmonary indexfrom immediately after sedation to end of procedure, up to 2 hourscalculated parameter
success of procedurefrom immediately after sedation to end of procedure, up to 2 hourssuccess or fail of sedation or procedure
Hemodynamic instabilityfrom immediately after sedation to end of procedure, up to 2 hoursheart rate and blood pressure change more than 20%
Medicationfrom immediately after sedation to end of procedure, up to 2 hourstype and dosage of sedatives
Airway obstructionfrom immediately after sedation to end of procedure, up to 2 hoursstridor, retraction

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026