Intraoperative Lung Ultrasound in Pediatric Patients (LUS)

Benefit of Intraoperative Lung Ultrasound in Pediatric Patients Undergoing Cardiac Surgery

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

Study Overview

• Status: Completed
• Conditions: Ultrasonography; Lung; Pediatrics; Cardiac Surgical Procedures; Perioperative Period
• Intervention / Treatment: Device: Lung ultrasound

• Study Type: Interventional
• Enrollment (Actual): 122
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 110-744
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 5 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control; 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; Lung ultrasound with appropriate interventions depending on the ultrasound finding
Active Comparator: 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.	Device: Lung ultrasound; Lung ultrasound with appropriate interventions depending on the ultrasound finding

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Publications and helpful links

General Publications

• Acosta CM, Maidana GA, Jacovitti D, Belaunzaran A, Cereceda S, Rae E, Molina A, Gonorazky S, Bohm SH, Tusman G. Accuracy of transthoracic lung ultrasound for diagnosing anesthesia-induced atelectasis in children. Anesthesiology. 2014 Jun;120(6):1370-9. doi: 10.1097/ALN.0000000000000231.
• Tusman G, Bohm SH, Tempra A, Melkun F, Garcia E, Turchetto E, Mulder PG, Lachmann B. Effects of recruitment maneuver on atelectasis in anesthetized children. Anesthesiology. 2003 Jan;98(1):14-22. doi: 10.1097/00000542-200301000-00006.
• Lutterbey G, Wattjes MP, Doerr D, Fischer NJ, Gieseke J Jr, Schild HH. Atelectasis in children undergoing either propofol infusion or positive pressure ventilation anesthesia for magnetic resonance imaging. Paediatr Anaesth. 2007 Feb;17(2):121-5. doi: 10.1111/j.1460-9592.2006.02045.x.
• Bronicki RA, Chang AC. Management of the postoperative pediatric cardiac surgical patient. Crit Care Med. 2011 Aug;39(8):1974-84. doi: 10.1097/CCM.0b013e31821b82a6.
• Vitale V, Ricci Z, Cogo P. Lung ultrasonography and pediatric cardiac surgery: first experience with a new tool for postoperative lung complications. Ann Thorac Surg. 2014 Apr;97(4):e121-4. doi: 10.1016/j.athoracsur.2014.01.060.

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: August 24, 2015
• First Submitted That Met QC Criteria: August 25, 2015
• First Posted (Estimate): August 28, 2015

Study Record Updates

• Last Update Posted (Estimate): December 26, 2016
• Last Update Submitted That Met QC Criteria: December 23, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 1507-062-687

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO