Lung Protection and Pediatric Cardiac Surgery

Assiut University

Status: Completed

Conditions: Lung Injury, Acute

Treatments: Procedure: cardiopulmonary bypass

Study type: Interventional

Funder types: Other

Identifiers

NCT03023670

IRB0000871180

Details and patient eligibility

About

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

Full 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:

Enrollment: 68 patients

Sex: All

Ages: 2 to 10 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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68 participants in 2 patient groups

Group A

Active Comparator group

Description:

This group will include patients with low flow of mixed oxygen / air (1:1L) during the period of cardiopulmonary bypass

Treatment:

Procedure: cardiopulmonary bypass

Procedure: cardiopulmonary bypass

Group B

Active Comparator group

Description:

This group will receive low rate (4\\min) with low tidal volume ( 2ml/kg ) during the period of cardiopulmonary bypass.

Treatment:

Procedure: cardiopulmonary bypass

Procedure: cardiopulmonary bypass