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Oxygen Reserve Index in Airway Surgery in Children

Sponsor
Seoul National University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05214950
Collaborator
(none)
90
Enrollment
1
Location
2
Arms
34.4
Anticipated Duration (Months)
2.6
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: ORI monitoring
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
A Randomized Controlled Trial of the Effect of Oxygen Reserve Index Monitoring for Preventing Hypoxia in Pediatric Airway Surgery
Actual Study Start Date :
Jan 18, 2022
Anticipated Primary Completion Date :
Nov 30, 2024
Anticipated Study Completion Date :
Nov 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: ORI monitoring

SpO2, ECG, NIBP, and oxygen reserve index monitoring

Device: ORI monitoring
Oxygen reserve index monitoring during the surgery
No Intervention: Standard monitoring

SpO2, ECG, NIBP monitoring

Outcome Measures

Primary Outcome Measures

  1. Hypoxemia [from induction of anesthesia to end of operation, about 3 hours]

    Oxygen desaturation <= 90%

Secondary Outcome Measures

  1. Hypoxemia duration [from induction of anesthesia to end of operation, about 3 hours]

    Total length of time patient experienced hypoxemia during hypoxemic event (oxygen desaturation <= 90%)

  2. Incidence and duration of severe hypoxemia [from induction of anesthesia to end of operation, about 3 hours]

    incidence and duration of oxygen desaturation <=85%

  3. Rescue oxygenation [from induction of anesthesia to end of operation, about 3 hours]

    the number of the surgical procedure is interrupted and the anesthetist attempts to improve oxygenation of the child.

  4. Hemodynamic instability [from induction of anesthesia to end of operation, about 3 hours]

    occurrence of hypotension requiring treatment, bradycardia requiring treatment, cardiac arrest with or without return of spontaneous circulation at any time during procedure

  5. unexpected pediatric intensive care admission [from induction of anesthesia to end of operation, about 3 hours]

    requirements of unexpected pediatric intensive care admission

  6. unanticipated postoperative mechanical support [from induction of anesthesia to end of operation, about 3 hours]

    Requirement for unanticipated postoperative mechanical ventilation or any other form of non-invasive ventilation including high-flow nasal oxygen

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Month to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • pediatric patients receiving airway surgery
Exclusion Criteria:

  • baseline oxygen saturation less than 95%

  • patients diagnosed as respiratory distress syndrome, bronchopulmonary dysplasia, pneumonia requiring oxygen supplements

Contacts and Locations

Locations

Site City State Country Postal Code
1 Jin-Tae Kim Seoul Korea, Republic of

Sponsors and Collaborators

  • Seoul National University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jin-Tae Kim, professor, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT05214950
Other Study ID Numbers:
  • 2112-055-1281
First Posted:
Jan 31, 2022
Last Update Posted:
Jan 31, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Hypoxia

Study Results

No Results Posted as of Jan 31, 2022