Skip to main content
OpenTrials
Completed

NCT Number: NCT05214950

Oxygen Reserve Index in Airway Surgery in Children

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypoxemia During Surgery

Age range

1 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jin-Tae Kim

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ORI monitoring

Device

Oxygen reserve index monitoring during the surgery

Primary outcomes

  1. Hypoxemia

    Time frame: from induction of anesthesia to end of operation, about 3 hours

    Oxygen desaturation <= 90%

Secondary outcomes

  1. Hypoxemia duration

    Time frame: 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

    Time frame: from induction of anesthesia to end of operation, about 3 hours

    incidence and duration of oxygen desaturation <=85%

  3. Rescue oxygenation

    Time frame: 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

    Time frame: 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

    Time frame: from induction of anesthesia to end of operation, about 3 hours

    requirements of unexpected pediatric intensive care admission

  6. unanticipated postoperative mechanical support

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

A Randomized Controlled Trial of the Effect of Oxygen Reserve Index Monitoring for Preventing Hypoxia in Pediatric Airway Surgery

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 31, 2022
Registry last updated
Apr 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.