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

• Sponsor: Kocaeli University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03651817
• Collaborator: (none)
• Enrollment: 32
• Location: 1
• Arms: 2
• Actual Duration (Months): 13.2
• Patients Per Site Per Month: 2.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Injury, Acute; Ventilator-Induced Lung Injury; Ventilator Adverse Event	Device: Mechanical ventilation	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 32 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Lung Protection Strategy in Open Heart Surgery: Which Tidal Volume is Better 8ml/kg or 6ml/kg
• Actual Study Start Date: Oct 15, 2018
• Actual Primary Completion Date: Nov 20, 2019
• Actual Study Completion Date: Nov 21, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. Changes in respiratory parameters [from the beginning of the operation to the end of the surgery]

   airway pressures will be continuously assessed

2. 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

3. 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

4. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Undergoing Cardiopulmonary bypass

Exclusion Criteria:

• Severe COPD

• Chronic Anemia

• Active Smoker

• Chronic kidney Disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kocaeli University Hospital	Kocaeli		Turkey

Sponsors and Collaborators

• Kocaeli University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tülay Çardaközü, Associate Professor, Kocaeli University
• ClinicalTrials.gov Identifier: NCT03651817
• Other Study ID Numbers: KÜ GOKAEK 2018/68
• First Posted: Aug 29, 2018
• Last Update Posted: Mar 5, 2020
• Last Verified: Mar 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lung Injury; Ventilator-Induced Lung Injury; Acute Lung Injury; Wounds and Injuries

Study Results

No Results Posted as of Mar 5, 2020