Hypoxemia During SurgeryNCT05214950
Oxygen Reserve Index in Airway Surgery in Children
A study testing ORI monitoring in people with Hypoxemia During Surgery, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study aimed to identify the effect of oxygen reserve index monitoring on the occurrence of oxygen desaturation (<90%) in pediatric patients undergoing airway surgery. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Hypoxemia During Surgery
- What is being tested?
- ORI monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteSouth Korea
- Study dates
- 18 Jan 2022to 30 Mar 2023
- 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 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- pediatric patients receiving airway surgery
Who cannot join
- baseline oxygen saturation less than 95%
- patients diagnosed as respiratory distress syndrome, bronchopulmonary dysplasia, pneumonia requiring oxygen supplements
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial of the Effect of Oxygen Reserve Index Monitoring for Preventing Hypoxia in Pediatric Airway Surgery
This study aimed to identify the effect of oxygen reserve index monitoring on the occurrence of oxygen desaturation (<90%) in pediatric patients undergoing airway surgery.
- Conditions
- Hypoxemia During Surgery
- Being tested
- ORI monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ORI monitoringDevice
Oxygen reserve index monitoring during the surgery
| Study group | Role | What they receive |
|---|---|---|
| ORI monitoring | Experimental | SpO2, ECG, NIBP, and oxygen reserve index monitoring Receives: Device: ORI monitoring |
| Standard monitoring | No intervention | SpO2, ECG, NIBP monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypoxemia
Oxygen desaturation <= 90%
Measured: from induction of anesthesia to end of operation, about 3 hours
Secondary outcomes (6)
Hypoxemia duration
Total length of time patient experienced hypoxemia during hypoxemic event (oxygen desaturation <= 90%)
Measured: from induction of anesthesia to end of operation, about 3 hours
Incidence and duration of severe hypoxemia
incidence and duration of oxygen desaturation <=85%
Measured: from induction of anesthesia to end of operation, about 3 hours
Rescue oxygenation
the number of the surgical procedure is interrupted and the anesthetist attempts to improve oxygenation of the child.
Measured: from induction of anesthesia to end of operation, about 3 hours
Hemodynamic instability
occurrence of hypotension requiring treatment, bradycardia requiring treatment, cardiac arrest with or without return of spontaneous circulation at any time during procedure
Measured: from induction of anesthesia to end of operation, about 3 hours
unexpected pediatric intensive care admission
requirements of unexpected pediatric intensive care admission
Measured: from induction of anesthesia to end of operation, about 3 hours
unanticipated postoperative mechanical support
Requirement for unanticipated postoperative mechanical ventilation or any other form of non-invasive ventilation including high-flow nasal oxygen
Measured: from induction of anesthesia to end of operation, about 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2022
- Study start18 Jan 2022
- Primary completion30 Mar 2023
- Study completion30 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoxemia During SurgeryStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 88 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
- NCT05214950
- Sponsor's protocol ID
- 2112-055-1281
- Status last verified
- Apr 2023
- First submitted
- 18 Jan 2022
- Last updated
- 24 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of the Effect of Oxygen Reserve Index Monitoring for Preventing Hypoxia in Pediatric Airway Surgery
- ClinicalTrials.gov ID
- NCT05214950
- Acronym / sponsor ID
- 2112-055-1281
- Conditions
- Hypoxemia During Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 18 Jan 2022 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 31 Jan 2022 (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 study aimed to identify the effect of oxygen reserve index monitoring on the occurrence of oxygen desaturation (<90%) in pediatric patients undergoing airway surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ORI monitoring | Experimental | Device: ORI monitoringSpO2, ECG, NIBP, and oxygen reserve index monitoring |
| Standard monitoring | No intervention | –SpO2, ECG, NIBP monitoring |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- pediatric patients receiving airway surgery
Key exclusion criteria (2 listed)
- baseline oxygen saturation less than 95%
- patients diagnosed as respiratory distress syndrome, bronchopulmonary dysplasia, pneumonia requiring oxygen supplements
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 |
|---|---|---|
| ORI monitoringOxygen reserve index monitoring during the surgery | Device | ORI monitoring |
Primary outcome
Hypoxemia
Time frame: from induction of anesthesia to end of operation, about 3 hours
Oxygen desaturation <= 90%
6 secondary outcomes
Hypoxemia duration
Time frame: from induction of anesthesia to end of operation, about 3 hours
Incidence and duration of severe hypoxemia
Time frame: from induction of anesthesia to end of operation, about 3 hours
Rescue oxygenation
Time frame: from induction of anesthesia to end of operation, about 3 hours
Hemodynamic instability
Time frame: from induction of anesthesia to end of operation, about 3 hours
unexpected pediatric intensive care admission
Time frame: from induction of anesthesia to end of operation, about 3 hours
unanticipated postoperative mechanical support
Time frame: from induction of anesthesia to end of operation, about 3 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2023.
- Individual participant dataSharing planned: Undecided
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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 ORI monitoring in people with Hypoxemia During Surgery, 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 2 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: finished, as of the sponsor's last update on 24 Apr 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Hypoxemia (time frame: from induction of anesthesia to end of operation, about 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Apr 2023.