Lung Protective Ventilation in Pulmonary Thromboendarterectomy (PTE) Patients
Primary Purpose
Chronic Thromboembolic Pulmonary Hypertension, Acute Lung Injury
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ventilation Strategy
Sponsored by
About this trial
This is an interventional prevention trial for Chronic Thromboembolic Pulmonary Hypertension focused on measuring Chronic Thromboembolic Pulmonary Hypertension, Lung Injury, Ventilation Strategies
Eligibility Criteria
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
Sites / Locations
- UCSD - Thornton Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Low tidal volume
Usual care
Arm Description
Tidal volume of 6 mL/Kg ideal body weight
Tidal volume of 10 mL/Kg ideal body weight
Outcomes
Primary Outcome Measures
Incidence of Reperfusion Lung Injury
Secondary Outcome Measures
ICU free days
Hospital Free Days
Mortality
Full Information
NCT ID
NCT00747045
First Posted
September 3, 2008
Last Updated
December 2, 2014
Sponsor
University of California, San Diego
1. Study Identification
Unique Protocol Identification Number
NCT00747045
Brief Title
Lung Protective Ventilation in Pulmonary Thromboendarterectomy (PTE) Patients
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 Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Thromboembolic Pulmonary Hypertension, Acute Lung Injury
Keywords
Chronic Thromboembolic Pulmonary Hypertension, Lung Injury, Ventilation Strategies
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
128 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low tidal volume
Arm Type
Experimental
Arm Description
Tidal volume of 6 mL/Kg ideal body weight
Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
Tidal volume of 10 mL/Kg ideal body weight
Intervention Type
Other
Intervention Name(s)
Ventilation Strategy
Intervention Description
Comparison of low vs standard tidal volumes in patients undergoing PTE
Primary Outcome Measure Information:
Title
Incidence of Reperfusion Lung Injury
Time Frame
72 Hours
Secondary Outcome Measure Information:
Title
ICU free days
Time Frame
28 days
Title
Hospital Free Days
Time Frame
28 days
Title
Mortality
Time Frame
28 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kim M Kerr, MD
Organizational Affiliation
UCSD Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSD - Thornton Hospital
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
26241077
Citation
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.
Results Reference
derived
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Lung Protective Ventilation in Pulmonary Thromboendarterectomy (PTE) Patients
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