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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
Kirsehir Ahi Evran University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Lung Injury, Acute

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
July 27, 2018
Last Updated
March 4, 2020
Sponsor
Kirsehir Ahi Evran University
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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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