Lung Protection Strategy in Open Heart Surgery: Which Tidal Volume is Better 8ml/kg or 6ml/kg

Study Overview
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Brief Summary
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Respiratory complications range from 8% to 79% of the frequency after open heart surgery where the patient is on-pump operated by cardiopulmonary machine. There were many changes in physiology due to anesthesia and cardiac surgery which cause volume and barotrauma complications with mechanical ventilation. These complications increase cost by prolonging morbidity and morbidity as well as hospital stay. Intraoperative and postoperative mechanical ventilation strategies can prevent these complications. CPB stimulates the systemic inflammatory response to the secretion of neutrophil, endotoxin and proinflammatory cytokines in the complex, increasing the permeability of the capillaries. Although coronary artery bypass graft surgery (CABG) is associated with a 0.4% to 2.0% acute respiratory distress syndrome (ARDS), mortality is quite high. Lung-protective ventilation strategies commonly used for prevention of ARDS. Ferrando et al. have proposed pulmonary ventilation with a tidal volume (TV) of less than 10 mL / kg as a pulmonary intraoperative protective ventilation strategy. Investigators aimed to compare oxygenation and ventilation parameters with respiratory mechanics in patients who underwent open heart surgery and were ventilated with 6 ml / kg tidal volume and 8 ml / kg TV, which were recommended as lung protective ventilation strategies during anesthesia.

Official Title
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Lung Protection Strategy in Open Heart Surgery: Which Tidal Volume is Better 8ml/kg or 6ml/kg

Conditions
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Lung Injury, Acute, Ventilator-Induced Lung Injury, Ventilator Adverse Event

Intervention / Treatment
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* Device: Mechanical ventilation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Undergoing Cardiopulmonary bypass Exclusion Criteria: Severe COPD Chronic Anemia Active Smoker Chronic kidney Disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: 6ml/kg volume<br>Patients ventilation will provided with a tidal volume of 6ml/kg | Device: Mechanical ventilation<br>* Patients will be ventilated with anesthesia machine according to the group they belong to<br>|
| Active Comparator: 8ml/kg volume<br>Patients ventilation will provided with a tidal volume of 8ml/kg | Device: Mechanical ventilation<br>* Patients will be ventilated with anesthesia machine according to the group they belong to<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of arterial carbondiokside pressure levels | Investigators will compare the changes in arterial carbondiokside levels in arterial blood gas samples | from the beginning of operation to 6th hour of post-extubation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in respiratory parameters | airway pressures will be continuously assessed | from the beginning of the operation to the end of the surgery | 
| Changes in Invasive blood pressures | Blood pressure will be continuously recorded and assessed due to time intervals | from the beginning of the operation to the end of the surgery | 
| Changes in heart rate | Heart rate will be continuously recorded and assessed due to time intervals | from the beginning of the operation to the end of the surgery | 
| Changes in central venous pressure | Continous central venous pressure will ve recorded and assessed due to time intervals | from the beginning of the operation to the end of the surgery |