Lung Ultrasound and Alveolar Recruitment in Mechanically Ventilated Infants

Study Overview
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Brief Summary
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Investigators hypothesized that lung ultrasound-assisted recruitment maneuver would be beneficial in mechanically ventilated infants compared to those who did not receive lung ultrasound and alveolar recruitment maneuver.

Official Title
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Preventive Effect of Lung Ultrasound and Alveolar Recruitment on Atelectasis in Mechanically Ventilated Infants

Conditions
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Pulmonary Atelectasis

Intervention / Treatment
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* Device: Lung ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Minor surgery less than 2 hours under general anesthesia Mechanically ventilated after endotracheal intubation Exclusion Criteria: 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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Minimum Age: 1 Day
Maximum Age: 1 Year

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>No intervention during the perioperative period. Perform lung ultrasound twice only for the diagnostic purpose after the endotracheal intubation and and at the end of surgery. | Device: Lung ultrasound<br>* Lung ultrasound on both hemithorax in supine position<br>|
| Active Comparator: Alveolar recruitment<br>Perform lung ultrasound twice during the perioperative period after the endotracheal intubation and and at the end of surgery. Conduct alveolar recruitment maneuver after first lung ultrasound assessment. | Device: Lung ultrasound<br>* Lung ultrasound on both hemithorax in supine position<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative incidence of pulmonary atelectasis |  | within the first day after the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative incidence of pulmonary atelectasis after endotracheal intubation |  | from the moment of endotracheal intubation until the end of surgery, up to 6 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 6 hours | 
| Postoperative incidence of pulse oximetry (SpO2) ≤ 95% (or 10% below the baseline value) |  | 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, infant, perioperative period, general anesthesia