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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hyperoxemia

Intervention / Treatment
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* Procedure: Titration of FiO2


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Conventional arm<br>Moderate hyperoxia as determined by T1 arterial blood gas. For moderate hyperoxemia (PaO2 > 300 mmHg), reduce the inspired oxygen concentration to 80% and for severe hyperoxemia to 70%. In the situation of hypoxia, where the peripheral oxygen saturation decreases to less than 95% even in 100% of FiO2, the following treatment is indicated: Fluid administration, inotropes administration (dopamine), alveolar recruitment, return to two-lung ventilation, and application of continuous positive airway pressure. | |
| Experimental: ORI arm<br>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. | Procedure: Titration of FiO2<br>* The inhaled oxygen concentration after one-lung ventilation will be treated by the group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| average Oxygen Reserve Index value |  | during one lung ventilation | 
| time-weighted average inspired oxygen fraction |  | during one lung ventilation | 
| incidence of hypoxemia |  | perioperative period | 
| incidence of perioperative complications |  | perioperative period |