Lung Protection and Pediatric Cardiac Surgery

Study Overview
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Brief Summary
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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
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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:

Official Title
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Ventilatory Patterns During Cardiopulmonary Bypass In Pediatric Cardiac Surgery

Conditions
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Lung Injury, Acute

Intervention / Treatment
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* Procedure: cardiopulmonary bypass
* Procedure: cardiopulmonary bypass


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>This group will include patients with low flow of mixed oxygen / air (1:1L) during the period of cardiopulmonary bypass | Procedure: cardiopulmonary bypass<br>* Low flow of mixed oxygen / air (1:1L) will be used during the period of cardiopulmonary bypass<br>* Other names: Control group;|
| Active Comparator: Group B<br>This group will receive low rate (4\min) with low tidal volume ( 2ml/kg ) during the period of cardiopulmonary bypass. | Procedure: cardiopulmonary bypass<br>* Low rate (4\min) with low tidal volume ( 2ml/kg ) will be used during the period of cardiopulmonary bypass.<br>* Other names: Low frequency group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Computerized tomography chest (CT chest) within 7 days postoperative |  | preoperative and within the first 7 days postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mechanical ventilation | Duration of mechanical ventilation (hours) | Within the first 7 days postoperative | 
| Intensive care unit stay | Intensive care unit stay | Within the first 7 days postoperative | 
| Intubation time | Intubation time (hours) | Within the first 7 days postoperative | 
| Arterial blood gases | Intraoperative and postoperative by appropriate scale | Within the first 7 days postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung, Cardiopulmonary Bypass, Pediatric, Cardiac surgery