Fraction of Inspired Oxygen and Atelectasis in Children

Study Overview
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Brief Summary
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Investigators hypothesized that maintaining low fraction of inspired oxygen would be beneficial to prevent anesthesia-induced atelectasis in mechanically ventilated children undergoing general anesthesia.

Official Title
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Effects of Fraction of Inspired Oxygen on Atelectasis in Mechanically Ventilated Children

Conditions
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Pulmonary Atelectasis

Intervention / Treatment
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* Device: Lung ultrasound
* Other: Respiratory management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Expected operation time between 1 to 3 hours under general anesthesia Mechanically ventilated after endotracheal intubation Exclusion Criteria: Cardiac, thoracic, abdominal surgery History of surgery on the lungs Laparoscopic surgery Abnormal preoperative chest radiograph findings including atelectasis, pneumothorax, pleural effusion, and pneumonia Considered inappropriate by the investigator

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>Perform recruitment maneuver with fraction of inspired oxygen (FiO2) of 1.0 after intubation under lung ultrasound guidance and maintain FiO2 of 0.6 during the general anesthesia. | Device: Lung ultrasound<br>* Lung ultrasound on both hemithorax in supine position<br>Other: Respiratory management<br>* Appropriate respiratory managements depending on the lung ultrasound findings<br>|
| Active Comparator: Low FiO2<br>Perform recruitment maneuver with low FiO2 of 0.3 after intubation under lung ultrasound guidance and maintain FiO2 of 0.3 during the general anesthesia. | Device: Lung ultrasound<br>* Lung ultrasound on both hemithorax in supine position<br>Other: Respiratory management<br>* Appropriate respiratory managements depending on the lung ultrasound findings<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of postoperative atelectasis |  | within the first day after the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of atelectasis after endotracheal intubation |  | from the moment of endotracheal intubation until the end of surgery, up to 4 hours | 
| Intraoperative incidence of pulse oximetry (SpO2) ≤ 95% (or 10% below the baseline value) |  | from the induction of general anesthesia until the end of the surgery, up to 4 hours | 
| Postoperative incidence of pulse oximetry (SpO2) ≤ 95% (or 10% below the baseline value) |  | within the first day after the surgery | 
| Postoperative incidence of fever (≥37.5℃) |  | within the first day after the surgery | 
| Postoperative incidence of respiratory complications |  | within the first day after the surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ultrasonography, child, perioperative period, general anesthesia, lung