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

NCT05912543 | Completed DMC

• 1 other identifier: 2205-156-1329
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperoxemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (2)

Conventional arm

NO INTERVENTION

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

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

Interventions

Titration of FiO2 PROCEDURE

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

ORI arm

Eligibility Criteria

• Age: Up to 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children under 7 years of age undergoing surgery under unilateral pulmonary ventilation
• Children with American Society of Anesthesiology physical status I, II, III

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, Seoul, 03080, South Korea

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 12, 2023
• First Posted: June 22, 2023
• Study Start: June 25, 2023
• Primary Completion: July 25, 2024
• Study Completion: July 31, 2024
• Last Updated: December 17, 2024

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)