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

Primary Purpose

Hyperoxemia

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Titration of FiO2
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hyperoxemia

Eligibility Criteria

undefined - 7 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Conventional arm

ORI arm

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

average Oxygen Reserve Index value
time-weighted average inspired oxygen fraction
incidence of hypoxemia
incidence of perioperative complications

Full Information

First Posted
June 12, 2023
Last Updated
June 12, 2023
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05912543
Brief Title
A Titration of Fractional Inspired Oxygen Using Oxygen Reserve Index in Child
Official Title
A Titration of Fractional Inspired Oxygen Using Oxygen Reserve Index (ORi™) During One-lung Ventilation in the Pediatric Patient: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 25, 2022 (Actual)
Primary Completion Date
July 25, 2024 (Anticipated)
Study Completion Date
May 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperoxemia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional arm
Arm Type
No Intervention
Arm 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.
Arm Title
ORI arm
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Titration of FiO2
Intervention Description
The inhaled oxygen concentration after one-lung ventilation will be treated by the group.
Primary Outcome Measure Information:
Title
The incidence of moderate to severe hyperoxemia in arterial blood gas analysis at T2 (30 minutes after one lung ventilation)
Description
arterial oxygen content over 200
Time Frame
30 minutes after initiation of one-lung ventilation
Secondary Outcome Measure Information:
Title
average Oxygen Reserve Index value
Time Frame
during one lung ventilation
Title
time-weighted average inspired oxygen fraction
Time Frame
during one lung ventilation
Title
incidence of hypoxemia
Time Frame
perioperative period
Title
incidence of perioperative complications
Time Frame
perioperative period

10. Eligibility

Sex
All
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ji-Hyun Lee, M.D., Ph.D.
Phone
02-2072-3664
Email
muslab6@snu.ac.kr
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ji-Hyun LEE, MD, PhD
Phone
02-2072-3661
Ext
82
Email
muslab@hanmail.net

12. IPD Sharing Statement

Plan to Share IPD
No

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

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