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

NCT ID: NCT03651817

Last Updated: 2020-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-15
• Study Completion Date: 2019-11-21

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

6ml/kg volume

Patients ventilation will provided with a tidal volume of 6ml/kg

Group Type: ACTIVE_COMPARATOR

Mechanical ventilation

Intervention Type: DEVICE

Patients will be ventilated with anesthesia machine according to the group they belong to

8ml/kg volume

Patients ventilation will provided with a tidal volume of 8ml/kg

Group Type: ACTIVE_COMPARATOR

Mechanical ventilation

Intervention Type: DEVICE

Patients will be ventilated with anesthesia machine according to the group they belong to

Interventions

Mechanical ventilation

Patients will be ventilated with anesthesia machine according to the group they belong to

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Undergoing Cardiopulmonary bypass

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kocaeli University

OTHER

Sponsor Role: lead

Responsible Party

Tülay Çardaközü

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kocaeli University Hospital

Kocaeli, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

KÜ GOKAEK 2018/68

Identifier Type: -

Identifier Source: org_study_id