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

Hyperoxemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05912543
• Other study ID #: 2205-156-1329
• Status: Recruiting
• Phase: N/A
• Start date: July 25, 2022
• Est. completion date: May 31, 2025

Study information

• Verified date: June 2023
• Source: Seoul National University Hospital
• Contact: Ji-Hyun Lee, M.D., Ph.D.
• Phone: 02-2072-3664
• Email: muslab6[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: May 31, 2025
• Est. primary completion date: July 25, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 7 Years

Eligibility

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

Related Conditions & MeSH terms

• Hyperoxemia
• Respiratory Aspiration

Intervention

Procedure:
• Titration of FiO2
The inhaled oxygen concentration after one-lung ventilation will be treated by the group.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of moderate to severe hyperoxemia in arterial blood gas analysis at T2 (30 minutes after one lung ventilation)	arterial oxygen content over 200	30 minutes after initiation of one-lung ventilation
Secondary	average Oxygen Reserve Index value		during one lung ventilation
Secondary	time-weighted average inspired oxygen fraction		during one lung ventilation
Secondary	incidence of hypoxemia		perioperative period
Secondary	incidence of perioperative complications		perioperative period