Lung Protection Strategy in Open Heart Surgery: Which Tidal Volume is Better 8ml/kg or 6ml/kg
Primary Purpose
Lung Injury, Acute, Ventilator-Induced Lung Injury, Ventilator Adverse Event
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Mechanical ventilation
Sponsored by
About this trial
This is an interventional prevention trial for Lung Injury, Acute
Eligibility Criteria
Inclusion Criteria:
- Undergoing Cardiopulmonary bypass
Exclusion Criteria:
- Severe COPD
- Chronic Anemia
- Active Smoker
- Chronic kidney Disease
Sites / Locations
- Kocaeli University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
6ml/kg volume
8ml/kg volume
Arm Description
Patients ventilation will provided with a tidal volume of 6ml/kg
Patients ventilation will provided with a tidal volume of 8ml/kg
Outcomes
Primary Outcome Measures
Change of arterial carbondiokside pressure levels
Investigators will compare the changes in arterial carbondiokside levels in arterial blood gas samples
Secondary Outcome Measures
Changes in respiratory parameters
airway pressures will be continuously assessed
Changes in Invasive blood pressures
Blood pressure will be continuously recorded and assessed due to time intervals
Changes in heart rate
Heart rate will be continuously recorded and assessed due to time intervals
Changes in central venous pressure
Continous central venous pressure will ve recorded and assessed due to time intervals
Full Information
NCT ID
NCT03651817
First Posted
July 27, 2018
Last Updated
March 4, 2020
Sponsor
Kirsehir Ahi Evran University
1. Study Identification
Unique Protocol Identification Number
NCT03651817
Brief Title
Lung Protection Strategy in Open Heart Surgery: Which Tidal Volume is Better 8ml/kg or 6ml/kg
Official Title
Lung Protection Strategy in Open Heart Surgery: Which Tidal Volume is Better 8ml/kg or 6ml/kg
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
October 15, 2018 (Actual)
Primary Completion Date
November 20, 2019 (Actual)
Study Completion Date
November 21, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kirsehir Ahi Evran University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Injury, Acute, Ventilator-Induced Lung Injury, Ventilator Adverse Event
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
6ml/kg volume
Arm Type
Active Comparator
Arm Description
Patients ventilation will provided with a tidal volume of 6ml/kg
Arm Title
8ml/kg volume
Arm Type
Active Comparator
Arm Description
Patients ventilation will provided with a tidal volume of 8ml/kg
Intervention Type
Device
Intervention Name(s)
Mechanical ventilation
Intervention Description
Patients will be ventilated with anesthesia machine according to the group they belong to
Primary Outcome Measure Information:
Title
Change of arterial carbondiokside pressure levels
Description
Investigators will compare the changes in arterial carbondiokside levels in arterial blood gas samples
Time Frame
from the beginning of operation to 6th hour of post-extubation
Secondary Outcome Measure Information:
Title
Changes in respiratory parameters
Description
airway pressures will be continuously assessed
Time Frame
from the beginning of the operation to the end of the surgery
Title
Changes in Invasive blood pressures
Description
Blood pressure will be continuously recorded and assessed due to time intervals
Time Frame
from the beginning of the operation to the end of the surgery
Title
Changes in heart rate
Description
Heart rate will be continuously recorded and assessed due to time intervals
Time Frame
from the beginning of the operation to the end of the surgery
Title
Changes in central venous pressure
Description
Continous central venous pressure will ve recorded and assessed due to time intervals
Time Frame
from the beginning of the operation to the end of the surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Undergoing Cardiopulmonary bypass
Exclusion Criteria:
Severe COPD
Chronic Anemia
Active Smoker
Chronic kidney Disease
Facility Information:
Facility Name
Kocaeli University Hospital
City
Kocaeli
Country
Turkey
12. IPD Sharing Statement
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Lung Protection Strategy in Open Heart Surgery: Which Tidal Volume is Better 8ml/kg or 6ml/kg
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