A Titration of Fractional Inspired Oxygen Using Oxygen Reserve Index in Child
Not Applicable
Completed
- Conditions
- Hyperoxemia
- Interventions
- Procedure: Titration of FiO2
- Registration Number
- NCT05912543
- Lead Sponsor
- Seoul National University Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ORI arm Titration of FiO2 Target ORi™ of 0.15, check the ORi™ every 5 minutes and adjust the inspired oxygen concentration in 5% increments. If the ORi™ decreases to less than 0.15, treat it in the same way as if hypoxia occurred in the conventional group.
- Primary Outcome Measures
Name Time Method 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 ventilation arterial oxygen content over 200
- Secondary Outcome Measures
Name Time Method time-weighted average inspired oxygen fraction during one lung ventilation incidence of perioperative complications perioperative period incidence of hypoxemia perioperative period average Oxygen Reserve Index value during one lung ventilation
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of