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

Seoul National University

Status: Completed

Conditions: Hyperoxemia

Treatments: Procedure: Titration of FiO2

Study type: Interventional

Funder types: Other

Identifiers

NCT05912543

2205-156-1329

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Ages: Under 7 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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70 participants in 2 patient groups

Conventional arm

No Intervention group

Description:

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.

ORI arm

Experimental group

Description:

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.

Treatment:

Procedure: Titration of FiO2