Lung Protective Ventilation in Pulmonary Thromboendarterectomy (PTE) Patients
NCT ID: NCT00747045
Last Updated: 2014-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
128 participants
INTERVENTIONAL
2008-08-31
2011-03-31
Brief Summary
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The landmark publication of the ARDSNET study demonstrated that a low tidal volume strategy of mechanical ventilation, decreased morbidity and mortality in patients who had acute respiratory distress syndrome (ARDS). Since then there have been some studies examining the role of a low tidal volume strategy in all patients who are mechanically ventilated. Some studies have demonstrated a decreased incidence of acute lung injury while others have failed to do the same. In patients at high risk for developing acute lung injury, such as patients undergoing PTE, there may be a benefit to using low tidal volumes to reduce the incidence of reperfusion lung injury.
To assess the efficacy of a low tidal volume ventilation strategy in patients undergoing PTE, 134 patients will be randomized at the time of surgery to either low tidal volumes (6ml/kg of ideal body weight), or standard tidal volumes (10ml/kg of ideal body weight). Patients will be followed clinically to assess for the development of reperfusion lung injury. This will be defined as the development of hypoxemia (PaO2/FiO2 ratio less than 300) and chest infiltrates in the area of reperfused lung with no other identifiable etiology within the first 72 hours of surgery. Patients will also be assessed for other factors known to contribute to acute lung injury including: plateau pressures, peak inspiratory pressures, fluid balance, and number of transfusions received. Secondary endpoints of the study will be: time to successful spontaneous breathing trial, ventilator free days, ICU free days, hospital free days, and mortality.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Low tidal volume
Tidal volume of 6 mL/Kg ideal body weight
Ventilation Strategy
Comparison of low vs standard tidal volumes in patients undergoing PTE
Usual care
Tidal volume of 10 mL/Kg ideal body weight
Ventilation Strategy
Comparison of low vs standard tidal volumes in patients undergoing PTE
Interventions
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Ventilation Strategy
Comparison of low vs standard tidal volumes in patients undergoing PTE
Eligibility Criteria
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Inclusion Criteria
* Evidence of CTEPH
* Acceptable surgical candidate
Exclusion Criteria
* Patient undergoing lung biopsy or CABG at time of surgery
18 Years
ALL
No
Sponsors
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University of California, San Diego
OTHER
Responsible Party
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Kim Kerr
Clinical Professor of Medicine
Principal Investigators
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Kim M Kerr, MD
Role: PRINCIPAL_INVESTIGATOR
UCSD Medical Center
Locations
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UCSD - Thornton Hospital
La Jolla, California, United States
Countries
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References
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Bates DM, Fernandes TM, Duwe BV, King BO, Banks DA, Test VJ, Fedullo PF, Kim NH, Madani MM, Jamieson SW, Auger WR, Kerr KM. Efficacy of a Low-Tidal Volume Ventilation Strategy to Prevent Reperfusion Lung Injury after Pulmonary Thromboendarterectomy. Ann Am Thorac Soc. 2015 Oct;12(10):1520-7. doi: 10.1513/AnnalsATS.201503-142OC.
Other Identifiers
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080721
Identifier Type: -
Identifier Source: org_study_id