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Sponsored by: |
Beth Israel Deaconess Medical Center |
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Information provided by: | Beth Israel Deaconess Medical Center |
ClinicalTrials.gov Identifier: | NCT00538161 |
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 |
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Acute Respiratory Distress Syndrome |
Other: Ventilation strategy |
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 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Sugantha Sundar, MD | 617 754-2675 | ssundar@bidmc.harvard.edu |
Contact: Daniel Talmor, MD | 617 754-2675 | dtalmor@bidmc.harvard.edu |
United States, Massachusetts | |
Beth Israel Deaconess Medical Center | Recruiting |
Boston, Massachusetts, United States, 02215 | |
Contact: Sugantha Sundar, MD 617-754-2675 ssundar@bidmc.harvard.edu |
Principal Investigator: | Sugantha Sundar, MD | Beth Israel Deaconess Medical Center |
Responsible Party: | Beth Israel Deaconess Medical Center ( Daniel Talmor MD ) |
Study ID Numbers: | 2007P000113 |
Study First Received: | September 30, 2007 |
Last Updated: | August 28, 2009 |
ClinicalTrials.gov Identifier: | NCT00538161 History of Changes |
Health Authority: | United States: Institutional Review Board |
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. |
Respiratory Tract Diseases Lung Diseases Respiration Disorders Respiratory Distress Syndrome, Adult Acute Respiratory Distress Syndrome |
Pathologic Processes Disease Respiratory Tract Diseases Lung Diseases |
Syndrome Respiration Disorders Respiratory Distress Syndrome, Adult |