Intraoperative Lung Ultrasound in Pediatric Patients

Study Overview
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Brief Summary
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Investigators hypothesized that perioperative lung ultrasound would be beneficial in pediatric patients undergoing cardiac surgery compared to those who did not receive lung ultrasound.

Official Title
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Benefit of Intraoperative Lung Ultrasound in Pediatric Patients Undergoing Cardiac Surgery

Conditions
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Ultrasonography, Pediatrics, Perioperative Period, Lung, Cardiac Surgical Procedures

Intervention / Treatment
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* Device: Lung ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acyanotic congenital heart disease patients undergoing cardiac surgery under general anesthesia Exclusion Criteria: History of surgery on the lungs Cyanotic congenital heart disease 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: 5 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: None (Open Label)


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 at the end of surgery and 6 to 12 hours after surgery in the intensive care unit. | Device: Lung ultrasound<br>* Lung ultrasound with appropriate interventions depending on the ultrasound finding<br>|
| Active Comparator: Ultrasound<br>Perform lung ultrasound three times during the perioperative period; after the induction of general anesthesia, at the end of surgery, and 6 to 12 hours after surgery in the intensive care unit. According to the lung ultrasound finding, conduct appropriate interventions such as, alveolar recruitment maneuver for atelectasis, or chest tube insertion for pneumothorax. | Device: Lung ultrasound<br>* Lung ultrasound with appropriate interventions depending on the ultrasound finding<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 24 hours | 
| Postoperative incidence of SpO2 ≤ 95% (or 10% below the baseline value) |  | within the first day after surgery | 
| Postoperative incidence of respiratory complications |  | within the first day after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative partial pressure of oxygen in arterial blood (PaO2) from arterial blood gas analysis |  | from the induction of general anesthesia until the end of the surgery, up to 24 hours | 
| Postoperative partial pressure of oxygen in arterial blood (PaO2) from arterial blood gas analysis |  | within the first day after surgery | 
| Initial SpO2 on arriving at pediatric intensive care unit |  | from the end of the surgery until postoperative 1 hour | 
| Days needed to wean from mechanical ventilation |  | up to 1 month |