Complication of Anesthesia Clinical Trial
— ETCO2Official title:
A Randomized Controlled Trial of the Effect of Capnography for Preventing Hypoxia in Minimally Sedated Pediatric Patients
Verified date | May 2024 |
Source | Seoul National University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This randomized controlled study investigated the effect of end-tidal carbon dioxide monitoring in pediatric patients undergoing minimal sedation.
Status | Active, not recruiting |
Enrollment | 214 |
Est. completion date | December 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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Jin-Tae Kim | Seoul |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Hospital |
Korea, Republic of,
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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