Effect of Low Tidal Volume Ventilation in Improving Oxygenation and Thus Reducing Acute Lung Injury in the Cardiac Surgical Patient - Full Text View

Sponsored by:	Beth Israel Deaconess Medical Center
Information provided by:	Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:	NCT00538161

Purpose

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.

Condition	Intervention
Acute Respiratory Distress Syndrome	Other: Ventilation strategy

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study
Official Title:	Effect of Low Tidal Volume Ventilation in Improving Oxygenation and Thus Reducing Acute Lung Injury in the Cardiac Surgical Patient

Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:

Time to extubation [ Designated as safety issue: No ]

Secondary Outcome Measures:

Oxygenation at 4 hours, 8 hours, 12 hours and 24 hours post surgery. [ Designated as safety issue: No ]

Estimated Enrollment:	120
Study Start Date:	October 2007
Study Completion Date:	October 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00538161

Locations

United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215

Sponsors and Collaborators

Beth Israel Deaconess Medical Center

Investigators

Principal Investigator:

Sugantha Sundar, MD

Beth Israel Deaconess Medical Center

More Information

Study ID Numbers:	2007P000113
Study First Received:	September 30, 2007
Last Updated:	December 1, 2008
ClinicalTrials.gov Identifier:	NCT00538161
Health Authority:	United States: Institutional Review Board

Keywords provided by Beth Israel Deaconess Medical Center:

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.

Study placed in the following topic categories:

Respiratory Tract Diseases
Lung Diseases
Respiration Disorders
Respiratory Distress Syndrome, Adult
Acute respiratory distress syndrome

Additional relevant MeSH terms:

Pathologic Processes
Disease
Syndrome

ClinicalTrials.gov processed this record on January 16, 2009