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NCT03023670 Clinical Trial

Lung Protection and Pediatric Cardiac Surgery

Lung Injury, Acute Clinical Trial

Official title:
Ventilatory Patterns During Cardiopulmonary Bypass In Pediatric Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03023670
Other study ID # IRB0000871180
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2017
Est. completion date April 2018

Study information
Verified date December 2018
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The lung is at risk for ischemic insults during total cardiopulmonary bypass because lung perfusion is maintained solely by the bronchial arterial system

Description:

The study will be performed in the pediatric cardiothoracic unit, pediatric Assiut University Hospital. After obtaining approval from the local ethics committee and written informed parents consent 60 patients will be included in this study according to the following criteria:

Recruitment information / eligibility
Status Completed
Enrollment 68
Est. completion date April 2018
Est. primary completion date March 2018
Accepts healthy volunteers No
Gender All
Age group 2 Years to 10 Years
Eligibility Inclusion Criteria:

- Elective cardiac surgery

- Ventricular septal defect (VSD).

- Atrial septal defect (ASD)

Exclusion Criteria:

- Cyanotic heart disease.

- Patients with preoperative chest problems.

- Patients with known renal or hepatic dysfunctions.

- Planned off-pump cardiac surgery.

- Emergency cardiac surgery.

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• cardiopulmonary bypass
Low flow of mixed oxygen / air (1:1L) will be used during the period of cardiopulmonary bypass
• cardiopulmonary bypass
Low rate (4\min) with low tidal volume ( 2ml/kg ) will be used during the period of cardiopulmonary bypass.

Locations
Country Name City State
Egypt Faculty of Medicine Assiut

Sponsors (1)
Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change from Baseline Computerized tomography chest (CT chest) within 7 days postoperative preoperative and within the first 7 days postoperative
Secondary Mechanical ventilation Duration of mechanical ventilation (hours) Within the first 7 days postoperative
Secondary Intensive care unit stay Intensive care unit stay Within the first 7 days postoperative
Secondary Intubation time Intubation time (hours) Within the first 7 days postoperative
Secondary Arterial blood gases Intraoperative and postoperative by appropriate scale Within the first 7 days postoperative
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