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

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.

Study Overview

• Status: Completed
• Conditions: Ventilator-Induced Lung Injury; Ventilator Adverse Event; Lung Injury, Acute
• Intervention / Treatment: Device: Mechanical ventilation

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Kocaeli, Turkey
    • Kocaeli University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Undergoing Cardiopulmonary bypass

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 6ml/kg volume; Patients ventilation will provided with a tidal volume of 6ml/kg	Device: Mechanical ventilation; Patients will be ventilated with anesthesia machine according to the group they belong to
Active Comparator: 8ml/kg volume; Patients ventilation will provided with a tidal volume of 8ml/kg	Device: Mechanical ventilation; Patients will be ventilated with anesthesia machine according to the group they belong to

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Kocaeli University

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2018
• Primary Completion (Actual): November 20, 2019
• Study Completion (Actual): November 21, 2019

Study Registration Dates

• First Submitted: July 27, 2018
• First Submitted That Met QC Criteria: August 27, 2018
• First Posted (Actual): August 29, 2018

Study Record Updates

• Last Update Posted (Actual): March 5, 2020
• Last Update Submitted That Met QC Criteria: March 4, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Thoracic Injuries; Wounds and Injuries; Acute Lung Injury; Lung Injury; Ventilator-Induced Lung Injury
• Other Study ID Numbers: KÜ GOKAEK 2018/68

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No