Lung Protection and Pediatric Cardiac Surgery

Not Applicable

Completed

• Conditions: Lung Injury, Acute
• Interventions: Procedure: cardiopulmonary bypass

• Registration Number: NCT03023670
• Lead Sponsor: Assiut University

Brief Summary

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

Detailed 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:

Study Timeline

• Study Start: 2017-01
• Study First Submitted: 2017-01-11
• Study First Submitted QC: 2017-01-17
• Study First Posted: 2017-01-18
• Primary Completion: 2018-03
• Study Completion: 2018-04
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-02
• Last Update Posted: 2018-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	cardiopulmonary bypass	This group will include patients with low flow of mixed oxygen / air (1:1L) during the period of cardiopulmonary bypass
Group B	cardiopulmonary bypass	This group will receive low rate (4\\min) with low tidal volume ( 2ml/kg ) during the period of cardiopulmonary bypass.

Primary Outcome Measures

Name	Time	Method
Change from Baseline Computerized tomography chest (CT chest) within 7 days postoperative	preoperative and within the first 7 days postoperative

Secondary Outcome Measures

Name	Time	Method
Arterial blood gases	Within the first 7 days postoperative	Intraoperative and postoperative by appropriate scale
Mechanical ventilation	Within the first 7 days postoperative	Duration of mechanical ventilation (hours)
Intensive care unit stay	Within the first 7 days postoperative	Intensive care unit stay
Intubation time	Within the first 7 days postoperative	Intubation time (hours)

Trial Locations

Locations (1)

Faculty of Medicine; 🇪🇬 Assiut, Egypt