Intraoperative Lung Ultrasound in Pediatric Patients

Not Applicable

Completed

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

• 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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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