A Titration of Fractional Inspired Oxygen Using Oxygen Reserve Index in Child
NCT ID: NCT05912543
Last Updated: 2024-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
70 participants
INTERVENTIONAL
2023-06-25
2024-07-31
Brief Summary
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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
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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Conventional arm
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.
No interventions assigned to this group
ORI arm
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.
Titration of FiO2
The inhaled oxygen concentration after one-lung ventilation will be treated by the group.
Interventions
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Titration of FiO2
The inhaled oxygen concentration after one-lung ventilation will be treated by the group.
Eligibility Criteria
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Inclusion Criteria
* Children with American Society of Anesthesiology physical status I, II, III
Exclusion Criteria
* 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
7 Years
ALL
No
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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Ji-Hyun Lee
Associate Professor
Locations
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Seoul National University Hospital
Seoul, Seoul, South Korea
Countries
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Other Identifiers
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2205-156-1329
Identifier Type: -
Identifier Source: org_study_id