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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05912543
Enrollment
70
Registered
2023-06-22
Start date
2023-06-25
Completion date
2024-07-31
Last updated
2024-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperoxemia

Brief 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.

Interventions

PROCEDURETitration of FiO2

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

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
No minimum to 7 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The incidence of moderate to severe hyperoxemia in arterial blood gas analysis at T2 (30 minutes after one lung ventilation)30 minutes after initiation of one-lung ventilationarterial oxygen content over 200

Secondary

MeasureTime frame
average Oxygen Reserve Index valueduring one lung ventilation
time-weighted average inspired oxygen fractionduring one lung ventilation
incidence of hypoxemiaperioperative period
incidence of perioperative complicationsperioperative period

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026