Intraoperative Lung Ultrasound in Pediatric Patients

Ultrasonography Clinical Trial

— LUS  

Official title:

Benefit of Intraoperative Lung Ultrasound in Pediatric Patients Undergoing Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02535013
• Other study ID #: 1507-062-687
• Status: Completed
• Phase: N/A
• First received: August 24, 2015
• Last updated: December 23, 2016
• Start date: August 2015
• Est. completion date: September 2016

Study information

• Verified date: December 2016
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: September 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 5 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cardiac Surgical Procedures
• Lung
• Pediatrics
• Perioperative Period
• Ultrasonography

Intervention

Device:
• Lung ultrasound
Lung ultrasound with appropriate interventions depending on the ultrasound finding

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (5)

Acosta CM, Maidana GA, Jacovitti D, Belaunzarán 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. — View Citation

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. Review. — View Citation

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. — View Citation

Tusman G, Böhm SH, Tempra A, Melkun F, García E, Turchetto E, Mulder PG, Lachmann B. Effects of recruitment maneuver on atelectasis in anesthetized children. Anesthesiology. 2003 Jan;98(1):14-22. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	Postoperative incidence of SpO2 = 95% (or 10% below the baseline value)		within the first day after surgery	Yes
Primary	Postoperative incidence of respiratory complications		within the first day after surgery	Yes
Secondary	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	Yes
Secondary	Postoperative partial pressure of oxygen in arterial blood (PaO2) from arterial blood gas analysis		within the first day after surgery	Yes
Secondary	Initial SpO2 on arriving at pediatric intensive care unit		from the end of the surgery until postoperative 1 hour	Yes
Secondary	Days needed to wean from mechanical ventilation		up to 1 month	Yes