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Perioperative Lung Ultrasonography for Fast-track Cardiac Surgery

Sponsor
Seoul National University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT03527862
Collaborator
(none)
35
Enrollment
1
Location
2
Arms
55.4
Anticipated Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Treatment according to lung ultrasonography
 N/A

Detailed Description

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
35 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
The Effect of Perioperative Lung Ultrasonography on Postoperative Outcomes in Children Undergoing Fast-track Cardiac Surgery
Actual Study Start Date :
May 8, 2018
Anticipated Primary Completion Date :
Dec 20, 2022
Anticipated Study Completion Date :
Dec 20, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Postoperative pulmonary complications [Up to postoperative day 5]

    Pleural effusion, atelectasis, diaphragmatic dysfunction, pulmonary infection, embolism, respiratory failure, aspiration, pneumothorax, chylothorax, bronchospasm

Secondary Outcome Measures

  1. Duration of the use of inotropes [Up to postoperative day 5]

    Duration of the use of inotropes

  2. Length of intensive care unit stay [up to postoperative day 5]

    Length of intensive care unit stay

  3. Lung ultrasonography findings [until 4 hours after surgery]

    Diagnostic lung ultrasonography

  4. ABGA result [within 4 hours after extubation]

    arterial blood gas analysis results

  5. Duration of oxygen therapy [Up to postoperative day 5]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 5 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Seoul National University Hospital Seoul Korea, Republic of 03080

Sponsors and Collaborators

  • Seoul National University Hospital

Investigators

  • Principal Investigator: Jin-Tae Kim, MD, PhD, Seoul National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jin-Tae Kim, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT03527862
Other Study ID Numbers:
  • H1803-123-932
First Posted:
May 17, 2018
Last Update Posted:
May 9, 2022
Last Verified:
May 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of May 9, 2022