End Tidal Carbon Dioxide in Minimal Sedation (ETCO2)

July 27, 2021 updated by: Jin-Tae Kim, Seoul National University Hospital

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

206

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • pediatric patients undergoing minimal sedation for procedure.

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: end tidal carbon dioxide monitoring
Other: end tidal carbon dioxide monitoring
We will monitor end tidal carbon dioxide with capnography during minimal sedation
No Intervention: Oxygen saturation monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of oxygen desaturation
Time Frame: from immediately after sedation to end of procedure, up to 2 hours
oxygen saturation lower than 95%
from immediately after sedation to end of procedure, up to 2 hours

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 7, 2021

Primary Completion (Anticipated)

April 30, 2024

Study Completion (Anticipated)

April 30, 2024

Study Registration Dates

First Submitted

April 25, 2021

First Submitted That Met QC Criteria

April 27, 2021

First Posted (Actual)

April 30, 2021

Study Record Updates

Last Update Posted (Actual)

July 28, 2021

Last Update Submitted That Met QC Criteria

July 27, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • D-2103-187-1208

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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