Back to resultsEffect of Low Tidal Volume Ventilation in Improving Oxygenation and Thus Reducing Acute Lung Injury in the Cardiac Surgical Patient
Primary Purpose
Acute Respiratory Distress Syndrome
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ventilation strategy
Sponsored by
About this trial
This is an interventional prevention trial for Acute Respiratory Distress Syndrome focused on measuring Acute lung injury, cardiac surgery, The incidence of ARDS after elective cardiac surgery is 1-3%, The impairment of lung function and oxygenation may occur in 20-80% of patients undergoing surgery., The purpose of this study is to assess the efficacy of low tidal volume ventilation., Reducing interleukin and cytokine production may prevent or reduce the incidence of acute lung injury.
Eligibility Criteria
Inclusion Criteria:
- Patients coming in for cardiac surgical procedures will be recruited into the study.
- Both men and women will be recruited into the study.
- All patients over the age of 18 will be recruited into the study.
- Discussion between the surgeon and the primary investigator will happen prior to approaching the patient to obtain informed consent.
Exclusion Criteria:
- Patients with preexisting respiratory failure and active infection will be excluded from the study.
- Patients undergoing one lung ventilation during surgery will be excluded from the study.
- Patients undergoing emergency cardiac surgery will be excluded from the study.
Sites / Locations
- Beth Israel Deaconess Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Low tidal volume arm
Conventional tidal volume arm
Arm Description
Outcomes
Primary Outcome Measures
Time to extubation
Secondary Outcome Measures
Oxygenation at 4 hours, 8 hours, 12 hours and 24 hours post surgery.
Full Information
NCT ID
NCT00538161
First Posted
September 30, 2007
Last Updated
March 15, 2017
Sponsor
Beth Israel Deaconess Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00538161
Brief Title
Effect of Low Tidal Volume Ventilation in Improving Oxygenation and Thus Reducing Acute Lung Injury in the Cardiac Surgical Patient
Official Title
Effect of Low Tidal Volume Ventilation in Improving Oxygenation and Thus Reducing Acute Lung Injury in the Cardiac Surgical Patient
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
January 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
We propose that as low tidal volume ventilation has proven to be beneficial in patients with established ARDS it may have a role in preventing the onset of acute lung injury in the cardiac surgical population. Institution of low tidal volume ventilation in the operating room may reduce the release of the cytokines and interleukins that have been known to contribute to the development of acute lung injury. In this study, we propose that the institution of low tidal volume ventilation in the operating room will reduce the incidence of acute lung injury. Measurement of PaO2 to FiO2 ratio twenty four and forty eight hours post operatively will help determine if there is a difference in oxygenation between the two groups. Chest X-ray findings, time to extubation and length of ICU stay will also determine if there is a role for low tidal volume ventilation in the operating room. We will also attempt to establish a causative mechanism by measuring plasma levels of cytokines known to be associated with the development of ARDS.
Detailed Description
Methods- A single center randomized controlled trial was undertaken in 149 patients comparing ventilation with 6 ml/kg TV to ventilation with 10 ml/kg TV in patients undergoing elective cardiac surgery. Study ventilator settings were applied immediately after induction of anesthesia and continued throughout surgery and the subsequent Intensive Care Unit stay. The primary endpoint of the study was time to extubation. Secondary endpoints included the proportion of patients extubated at 6 hours, indices of lung mechanics and gas exchange as well as patient clinical outcomes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Distress Syndrome
Keywords
Acute lung injury, cardiac surgery, The incidence of ARDS after elective cardiac surgery is 1-3%, The impairment of lung function and oxygenation may occur in 20-80% of patients undergoing surgery., The purpose of this study is to assess the efficacy of low tidal volume ventilation., Reducing interleukin and cytokine production may prevent or reduce the incidence of acute lung injury.
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low tidal volume arm
Arm Type
Experimental
Arm Title
Conventional tidal volume arm
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Ventilation strategy
Primary Outcome Measure Information:
Title
Time to extubation
Time Frame
the time patient was extubated in the ICU
Secondary Outcome Measure Information:
Title
Oxygenation at 4 hours, 8 hours, 12 hours and 24 hours post surgery.
Time Frame
measurement of blood gas at 4, 8 , 12 and 24 hours post surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients coming in for cardiac surgical procedures will be recruited into the study.
Both men and women will be recruited into the study.
All patients over the age of 18 will be recruited into the study.
Discussion between the surgeon and the primary investigator will happen prior to approaching the patient to obtain informed consent.
Exclusion Criteria:
Patients with preexisting respiratory failure and active infection will be excluded from the study.
Patients undergoing one lung ventilation during surgery will be excluded from the study.
Patients undergoing emergency cardiac surgery will be excluded from the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Talmor, MD
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effect of Low Tidal Volume Ventilation in Improving Oxygenation and Thus Reducing Acute Lung Injury in the Cardiac Surgical Patient
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