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Lung Protective Ventilation in Pulmonary Thromboendarterectomy (PTE) Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00747045
Recruitment Status : Completed
First Posted : September 4, 2008
Last Update Posted : December 3, 2014
Information provided by (Responsible Party):
Kim Kerr, University of California, San Diego

Brief Summary:

Chronic thromboembolic pulmonary hypertension (CTEPH) is caused by unresolved thromboemboli in the pulmonary arteries, which lead to pulmonary hypertension and, left untreated, right heart failure. This disease can be potentially cured by performing a pulmonary thromboendarterectomy (PTE) to remove the blood clots. The surgery is not without risk and the most worrisome complication is the development of a form of acute lung injury called reperfusion lung injury, which occurs in about 40 percent of patients.

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.

Condition or disease Intervention/treatment Phase
Chronic Thromboembolic Pulmonary Hypertension Acute Lung Injury Other: Ventilation Strategy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Prospective Single Blind Controlled Study to Assess the Efficacy of a Lung Protective Ventilation Strategy in the Prevention of Reperfusion Lung Injury Following PTE
Study Start Date : August 2008
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Arm Intervention/treatment
Experimental: Low tidal volume
Tidal volume of 6 mL/Kg ideal body weight
Other: Ventilation Strategy
Comparison of low vs standard tidal volumes in patients undergoing PTE

Active Comparator: Usual care
Tidal volume of 10 mL/Kg ideal body weight
Other: Ventilation Strategy
Comparison of low vs standard tidal volumes in patients undergoing PTE

Primary Outcome Measures :
  1. Incidence of Reperfusion Lung Injury [ Time Frame: 72 Hours ]

Secondary Outcome Measures :
  1. ICU free days [ Time Frame: 28 days ]
  2. Hospital Free Days [ Time Frame: 28 days ]
  3. Mortality [ Time Frame: 28 Days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age 18 years of age
  • Evidence of CTEPH
  • Acceptable surgical candidate

Exclusion Criteria:

  • BMI > 40
  • Patient undergoing lung biopsy or CABG at time of surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00747045

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United States, California
UCSD - Thornton Hospital
La Jolla, California, United States, 92037
Sponsors and Collaborators
University of California, San Diego
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Principal Investigator: Kim M Kerr, MD UCSD Medical Center
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Kim Kerr, Clinical Professor of Medicine, University of California, San Diego Identifier: NCT00747045    
Other Study ID Numbers: 080721
First Posted: September 4, 2008    Key Record Dates
Last Update Posted: December 3, 2014
Last Verified: December 2014
Keywords provided by Kim Kerr, University of California, San Diego:
Chronic Thromboembolic Pulmonary Hypertension
Lung Injury
Ventilation Strategies
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Lung Injury
Acute Lung Injury
Respiratory Distress Syndrome, Adult
Wounds and Injuries
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Thoracic Injuries
Respiration Disorders