Ultrasonography Clinical Trial
— LUSOfficial title:
Benefit of Intraoperative Lung Ultrasound in Pediatric Patients Undergoing Cardiac Surgery
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 |
Investigators hypothesized that perioperative lung ultrasound would be beneficial in pediatric patients undergoing cardiac surgery compared to those who did not receive lung ultrasound.
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul National University Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Hospital |
Korea, Republic of,
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
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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