Skip to main content
OpenTrials
Completed

NCT Number: NCT05912543

A Titration of Fractional Inspired Oxygen Using Oxygen Reserve Index in Child

The purpose of this prospective randomized controlled trial is to determine whether using the Oxygen Reserve Index can prevent hyperoxemia in pediatric patients receiving single-lung ventilation.

Participants will have their FiO2 adjusted in a prescribed manner based on the arm to which they are assigned.

The researchers will compare whether blood oxygen levels were lower in the ORI group.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hyperoxemia

Age range

Up to 7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Children under 7 years of age undergoing surgery under unilateral pulmonary ventilation
  • Children with American Society of Anesthesiology physical status I, II, III

Exclusion criteria

  • Patient who have chronic respiratory failure
  • Patient who have a history of bronchopulmonary dysplasia, respiratory distress syndrome of neonate, laryngomalacia, tracheomalacia or tracheal stenosis
  • Patient whose initial Oxygen Reserve Index value is zero
  • Patient who need supplementary oxygen before surgery

Treatment and study plan

Titration of FiO2

Procedure

The inhaled oxygen concentration after one-lung ventilation will be treated by the group.

Primary outcomes

  1. The incidence of moderate to severe hyperoxemia in arterial blood gas analysis at T2 (30 minutes after one lung ventilation)

    Time frame: 30 minutes after initiation of one-lung ventilation

    arterial oxygen content over 200

Secondary outcomes

  1. average Oxygen Reserve Index value

    Time frame: during one lung ventilation

  2. time-weighted average inspired oxygen fraction

    Time frame: during one lung ventilation

  3. incidence of hypoxemia

    Time frame: perioperative period

  4. incidence of perioperative complications

    Time frame: perioperative period

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

A Titration of Fractional Inspired Oxygen Using Oxygen Reserve Index (ORi™) During One-lung Ventilation in the Pediatric Patient: a Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 22, 2023
Registry last updated
Dec 17, 2024

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.