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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02535013
Other study ID # 1507-062-687
Secondary ID
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


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
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