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

Not Applicable

Completed

• Conditions: Ventilator-Induced Lung Injury; Ventilator Adverse Event; Lung Injury, Acute
• Interventions: Device: Mechanical ventilation

• Registration Number: NCT03651817
• Lead Sponsor: Kocaeli University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-27
• Study First Submitted QC: 2018-08-27
• Study First Posted: 2018-08-29
• Study Start: 2018-10-15
• Primary Completion: 2019-11-20
• Study Completion: 2019-11-21
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-04
• Last Update Posted: 2020-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Undergoing Cardiopulmonary bypass

Exclusion Criteria

• Severe COPD
• Chronic Anemia
• Active Smoker
• Chronic kidney Disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
6ml/kg volume	Mechanical ventilation	Patients ventilation will provided with a tidal volume of 6ml/kg
8ml/kg volume	Mechanical ventilation	Patients ventilation will provided with a tidal volume of 8ml/kg

Primary Outcome Measures

Name	Time	Method
Change of arterial carbondiokside pressure levels	from the beginning of operation to 6th hour of post-extubation	Investigators will compare the changes in arterial carbondiokside levels in arterial blood gas samples

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Kocaeli University Hospital; 🇹🇷 Kocaeli, Turkey