Lung Protective Ventilation in Pulmonary Thromboendarterectomy (PTE) Patients
Recruitment status was Recruiting
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Purpose
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 | Intervention |
|---|---|
|
Chronic Thromboembolic Pulmonary Hypertension Acute Lung Injury |
Other: Ventilation Strategy |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) 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 |
- Incidence of Reperfusion Lung Injury [ Time Frame: 72 Hours ] [ Designated as safety issue: No ]
- ICU free days [ Time Frame: 28 days ] [ Designated as safety issue: No ]
- Hospital Free Days [ Time Frame: 28 days ] [ Designated as safety issue: No ]
- Mortality [ Time Frame: 28 Days ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 116 |
| Study Start Date: | August 2008 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
-
Other: Ventilation Strategy
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations| Contact: Beau V Duwe, MD | 8586577140 | bduwe@ucsd.edu |
| Contact: Kim M Kerr, MD | 8586577140 | kmkerr@ucsd.edu |
| United States, California | |
| UCSD - Thornton Hospital | Recruiting |
| La Jolla, California, United States, 92037 | |
| Principal Investigator: | Kim M Kerr, MD | UCSD Medical Center |
More Information
No publications provided
| Responsible Party: | Kim M. Kerr, University of California San Diego |
| ClinicalTrials.gov Identifier: | NCT00747045 History of Changes |
| Other Study ID Numbers: | 080721 |
| Study First Received: | September 3, 2008 |
| Last Updated: | January 11, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of California, San Diego:
|
Chronic Thromboembolic Pulmonary Hypertension Lung Injury Ventilation Strategies |
Additional relevant MeSH terms:
|
Hypertension Hypertension, Pulmonary Acute Lung Injury Respiratory Distress Syndrome, Adult Lung Injury Vascular Diseases |
Cardiovascular Diseases Lung Diseases Respiratory Tract Diseases Respiration Disorders Thoracic Injuries Wounds and Injuries |
ClinicalTrials.gov processed this record on May 21, 2013