NCT02535013

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

August 24, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 28, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

December 26, 2016

Status Verified

December 1, 2016

Enrollment Period

1 year

First QC Date

August 24, 2015

Last Update Submit

December 23, 2016

Conditions

UltrasonographyPediatricsPerioperative PeriodLungCardiac Surgical Procedures

Outcome Measures

Primary Outcomes (3)

  • 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

  • Postoperative incidence of SpO2 ≤ 95% (or 10% below the baseline value)

    within the first day after surgery

  • Postoperative incidence of respiratory complications

    within the first day after surgery

Secondary Outcomes (4)

  • 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

  • Postoperative partial pressure of oxygen in arterial blood (PaO2) from arterial blood gas analysis

    within the first day after surgery

  • Initial SpO2 on arriving at pediatric intensive care unit

    from the end of the surgery until postoperative 1 hour

  • Days needed to wean from mechanical ventilation

    up to 1 month

Study Arms (2)

Control

PLACEBO COMPARATOR

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.

Device: Lung ultrasound

Ultrasound

ACTIVE COMPARATOR

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.

Device: Lung ultrasound

Interventions

Lung ultrasoundDEVICE

Lung ultrasound with appropriate interventions depending on the ultrasound finding

ControlUltrasound

Eligibility Criteria

AgeUp to 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Acyanotic congenital heart disease patients undergoing cardiac surgery under general anesthesia

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, Seoul, 110-744, South Korea

Location

Related Publications (5)

  • 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.

    PMID: 17238882BACKGROUND

  • 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.

    PMID: 12502973BACKGROUND

  • 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.

    PMID: 21768801BACKGROUND

  • 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.

    PMID: 24694455BACKGROUND

  • 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.

    PMID: 24662376BACKGROUND

Study Officials

  • Jin-Tae Kim

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

August 24, 2015

First Posted

August 28, 2015

Study Start

August 1, 2015

Primary Completion

August 1, 2016

Study Completion

September 1, 2016

Last Updated

December 26, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)