Clinical trial NCT02535013: Intraoperative Lung Ultrasound in Pediatric Patients
Official title: Benefit of Intraoperative Lung Ultrasound in Pediatric Patients Undergoing Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ultrasonography
Pediatrics
Perioperative Period
Lung
Cardiac Surgical Procedures
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2015-08-28
Enrollment: 122
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Intraoperative incidence of pulse oximetry (SpO2) ≤ 95% (or 10% below the baseline value)
timeFrame: from the induction of general anesthesia until the end of the surgery, up to 24 hours
measure: Postoperative incidence of SpO2 ≤ 95% (or 10% below the baseline value)
timeFrame: within the first day after surgery
measure: Postoperative incidence of respiratory complications
timeFrame: within the first day after surgery
Secondary outcomes:
measure: Intraoperative partial pressure of oxygen in arterial blood (PaO2) from arterial blood gas analysis
timeFrame: from the induction of general anesthesia until the end of the surgery, up to 24 hours
measure: Postoperative partial pressure of oxygen in arterial blood (PaO2) from arterial blood gas analysis
timeFrame: within the first day after surgery
measure: Initial SpO2 on arriving at pediatric intensive care unit
timeFrame: from the end of the surgery until postoperative 1 hour
measure: Days needed to wean from mechanical ventilation
timeFrame: up to 1 month
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jin-Tae Kim
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1111/j.1460-9592.2006.02045.x.
citation: 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.
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.
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.
citation: 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.