Perioperative Lung Ultrasonography for Fast-track Cardiac Surgery

May 3, 2022 updated by: Jin-Tae Kim, Seoul National University Hospital

The Effect of Perioperative Lung Ultrasonography on Postoperative Outcomes in Children Undergoing Fast-track Cardiac Surgery

The investigators evaluate the usefulness of lung ultrasonography in the perioperative period for postoperative outcomes in children undergoing fast track cardiac surgery.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Some appropriate intervention such as recruitment maneuver, chest tube insertion, or diuretics will be applied depending on lung ultrasound findings.

Study Type

Interventional

Enrollment (Anticipated)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 03080
        • Recruiting
        • Seoul National University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children receiving fast track cardiac surgery protocol
  • = or < 5 years old
  • Children with acyanotic heart disease

Exclusion Criteria:

  • Previous history of lung resection surgery
  • Preoperative chest x-ray abnormalities
  • Postoperative cyanosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
No intervention is performed. Lung ultrasonography is performed within 4 hours after surgery for diagnostic purpose.
Experimental: lung ultrasonography group
Lung ultrasonography is performed three times; after tracheal intubation, before surgery end, and within 4 hours after surgery. In this group, respiratory management is performed according to diagnosis.
Other: Treatment according to lung ultrasonography
Appropriate treatment for atelectasis, pleural effusion, pulmonary edema, pneumothorax or pneumonia which are confirmed by lung ultrasonography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pulmonary complications
Time Frame: Up to postoperative day 5
Pleural effusion, atelectasis, diaphragmatic dysfunction, pulmonary infection, embolism, respiratory failure, aspiration, pneumothorax, chylothorax, bronchospasm
Up to postoperative day 5

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of the use of inotropes
Time Frame: Up to postoperative day 5
Duration of the use of inotropes
Up to postoperative day 5
Length of intensive care unit stay
Time Frame: up to postoperative day 5
Length of intensive care unit stay
up to postoperative day 5
Lung ultrasonography findings
Time Frame: until 4 hours after surgery
Diagnostic lung ultrasonography
until 4 hours after surgery
ABGA result
Time Frame: within 4 hours after extubation
arterial blood gas analysis results
within 4 hours after extubation
Duration of oxygen therapy
Time Frame: Up to postoperative day 5
Up to postoperative day 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 8, 2018

Primary Completion (Anticipated)

December 20, 2022

Study Completion (Anticipated)

December 20, 2022

Study Registration Dates

First Submitted

April 24, 2018

First Submitted That Met QC Criteria

May 5, 2018

First Posted (Actual)

May 17, 2018

Study Record Updates

Last Update Posted (Actual)

May 9, 2022

Last Update Submitted That Met QC Criteria

May 3, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • H1803-123-932

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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