Intraoperative Lung Ultrasound in Pediatric Patients

Not Applicable

Completed

• Conditions: Cardiac Surgical Procedures; Pediatrics; Ultrasonography; Perioperative Period; Lung
• Interventions: Device: Lung ultrasound

• Registration Number: NCT02535013
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-08-24
• Study First Submitted QC: 2015-08-25
• Study First Posted: 2015-08-28
• Primary Completion: 2016-08
• Study Completion: 2016-09
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-23
• Last Update Posted: 2016-12-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

Inclusion Criteria

• Acyanotic congenital heart disease patients undergoing cardiac surgery under general anesthesia

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Lung ultrasound	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.
Ultrasound	Lung ultrasound	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.

Primary Outcome Measures

Name	Time	Method
Postoperative incidence of SpO2 ≤ 95% (or 10% below the baseline value)	within the first day after surgery
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 respiratory complications	within the first day after surgery

Secondary Outcome Measures

Name	Time	Method
Postoperative partial pressure of oxygen in arterial blood (PaO2) from arterial blood gas analysis	within the first day after surgery
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
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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of