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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.
 
ClinicalTrials.gov Identifier: NCT00747045
Recruitment Status : Completed
First Posted : September 4, 2008
Last Update Posted : December 3, 2014
Sponsor:
Information provided by (Responsible Party):
Kim Kerr, University of California, San Diego

Tracking Information
First Submitted Date  ICMJE September 3, 2008
First Posted Date  ICMJE September 4, 2008
Last Update Posted Date December 3, 2014
Study Start Date  ICMJE August 2008
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 3, 2008)
Incidence of Reperfusion Lung Injury [ Time Frame: 72 Hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 3, 2008)
  • ICU free days [ Time Frame: 28 days ]
  • Hospital Free Days [ Time Frame: 28 days ]
  • Mortality [ Time Frame: 28 Days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lung Protective Ventilation in Pulmonary Thromboendarterectomy (PTE) Patients
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Chronic Thromboembolic Pulmonary Hypertension
  • Acute Lung Injury
Intervention  ICMJE Other: Ventilation Strategy
Comparison of low vs standard tidal volumes in patients undergoing PTE
Study Arms  ICMJE
  • Experimental: Low tidal volume
    Tidal volume of 6 mL/Kg ideal body weight
    Intervention: Other: Ventilation Strategy
  • Active Comparator: Usual care
    Tidal volume of 10 mL/Kg ideal body weight
    Intervention: Other: Ventilation Strategy
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 2, 2014)
128
Original Estimated Enrollment  ICMJE
 (submitted: September 3, 2008)
116
Actual Study Completion Date  ICMJE March 2011
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00747045
Other Study ID Numbers  ICMJE 080721
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kim Kerr, University of California, San Diego
Study Sponsor  ICMJE University of California, San Diego
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kim M Kerr, MD UCSD Medical Center
PRS Account University of California, San Diego
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP