Complication of AnesthesiaETCO2NCT04868266
End Tidal Carbon Dioxide in Minimal Sedation
A study testing end tidal carbon dioxide monitoring in people with Complication of Anesthesia, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This randomized controlled study investigated the effect of end-tidal carbon dioxide monitoring in pediatric patients undergoing minimal sedation. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Complication of Anesthesia
- What is being tested?
- end tidal carbon dioxide monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Jul 2021to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- pediatric patients undergoing minimal sedation for procedure.
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Complication of Anesthesia
- Being tested
- end tidal carbon dioxide monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
end tidal carbon dioxide monitoringOther
We will monitor end tidal carbon dioxide with capnography during minimal sedation
| Study group | Role | What they receive |
|---|---|---|
| end tidal carbon dioxide monitoring | Experimental | Not described Receives: Other: end tidal carbon dioxide monitoring |
| Oxygen saturation monitoring | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of oxygen desaturation
oxygen saturation lower than 95%
Measured: from immediately after sedation to end of procedure, up to 2 hours
Secondary outcomes (11)
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
Measured: from immediately after sedation to end of procedure, up to 2 hours
Severe oxygen desaturation
oxygen saturation lower than 85%, 90%
Measured: from immediately after sedation to end of procedure, up to 2 hours
Lowest oxygen saturation
value of oxygen saturation
Measured: from immediately after sedation to end of procedure, up to 2 hours
Episode of apnea
capnography flat line more than 5 seconds
Measured: from immediately after sedation to end of procedure, up to 2 hours
sedation level
6-point pediatric sedation state scale
Measured: from immediately after sedation to end of procedure, up to 2 hours
inappropriate monitoring
the duration of inappropriate capnography monitoring
Measured: from immediately after sedation to end of procedure, up to 2 hours
Airway obstruction
stridor, retraction
Measured: from immediately after sedation to end of procedure, up to 2 hours
Integrated pulmonary index
calculated parameter
Measured: from immediately after sedation to end of procedure, up to 2 hours
success of procedure
success or fail of sedation or procedure
Measured: from immediately after sedation to end of procedure, up to 2 hours
Hemodynamic instability
heart rate and blood pressure change more than 20%
Measured: from immediately after sedation to end of procedure, up to 2 hours
Medication
type and dosage of sedatives
Measured: from immediately after sedation to end of procedure, up to 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2021
- Study start7 Jul 2021
- Primary completion30 Apr 2024
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Complication of AnesthesiaStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Tae Kim, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04868266
- Sponsor's protocol ID
- D-2103-187-1208
- Acronym
- ETCO2
- Status last verified
- May 2024
- First submitted
- 25 Apr 2021
- Last updated
- 31 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kim EH, Park JB, Ji SH, Jang YE, Lee JH, Kim HS, Kim JT. Using capnography in children to prevent oxygen desaturation during procedural sedation: A randomised trial. Eur J Anaesthesiol. 2025 Nov 1;42(11):1034-1041. doi: 10.1097/EJA.0000000000002250. Epub 2025 Aug 11.
PubMed 40810300
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of the Effect of Capnography for Preventing Hypoxia in Minimally Sedated Pediatric Patients
- ClinicalTrials.gov ID
- NCT04868266
- Acronym / sponsor ID
- ETCO2 / D-2103-187-1208
- Conditions
- Complication of Anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 214 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 7 Jul 2021 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 30 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized controlled study investigated the effect of end-tidal carbon dioxide monitoring in pediatric patients undergoing minimal sedation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| end tidal carbon dioxide monitoring | Experimental | Other: end tidal carbon dioxide monitoring |
| Oxygen saturation monitoring | No intervention | – |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- pediatric patients undergoing minimal sedation for procedure.
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| end tidal carbon dioxide monitoringWe will monitor end tidal carbon dioxide with capnography during minimal sedation | Other | end tidal carbon dioxide monitoring |
Primary outcome
Incidence of oxygen desaturation
Time frame: from immediately after sedation to end of procedure, up to 2 hours
oxygen saturation lower than 95%
11 secondary outcomes
number of Staff intervetions
Time frame: 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
Lowest oxygen saturation
Time frame: 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
sedation level
Time frame: 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
Airway obstruction
Time frame: 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
success of procedure
Time frame: 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
Medication
Time frame: from immediately after sedation to end of procedure, up to 2 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2024.
- Derived from this study: PubMed 40810300Kim EH, Park JB, Ji SH, Jang YE, Lee JH, Kim HS, Kim JT. Using capnography in children to prevent oxygen desaturation during procedural sedation: A randomised trial. Eur J Anaesthesiol. 2025 Nov 1;42(11):1034-1041. doi: 10.1097/EJA.0000000000002250. Epub 2025 Aug 11.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing end tidal carbon dioxide monitoring in people with Complication of Anesthesia, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of oxygen desaturation (time frame: from immediately after sedation to end of procedure, up to 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04868266, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2024.