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Intraoperative Lung Ultrasound in Pediatric Patients

NCT ID: NCT02535013

Last Updated: 2016-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2016-09-30

Brief Summary

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

Detailed Description

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Conditions

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Ultrasonography Pediatrics Perioperative Period Lung Cardiac Surgical Procedures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type PLACEBO_COMPARATOR

Lung ultrasound

Intervention Type DEVICE

Lung ultrasound with appropriate interventions depending on the ultrasound finding

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.

Group Type ACTIVE_COMPARATOR

Lung ultrasound

Intervention Type DEVICE

Lung ultrasound with appropriate interventions depending on the ultrasound finding

Interventions

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Lung ultrasound

Lung ultrasound with appropriate interventions depending on the ultrasound finding

Intervention Type DEVICE

Eligibility Criteria

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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
Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jin-Tae Kim

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jin-Tae Kim

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, Seoul, South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type BACKGROUND
PMID: 17238882 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12502973 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21768801 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24694455 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24662376 (View on PubMed)

Other Identifiers

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1507-062-687

Identifier Type: -

Identifier Source: org_study_id