Lung Protective Ventilation in Pulmonary Thromboendarterectomy (PTE) Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kim Kerr, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT00747045
First received: September 3, 2008
Last updated: December 2, 2014
Last verified: December 2014
  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: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • Incidence of Reperfusion Lung Injury [ Time Frame: 72 Hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 128
Study Start Date: August 2008
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00747045

Locations
United States, California
UCSD - Thornton Hospital
La Jolla, California, United States, 92037
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: Kim M Kerr, MD UCSD Medical Center
  More Information

No publications provided

Responsible Party: Kim Kerr, Clinical Professor of Medicine, 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: December 2, 2014
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:
Acute Lung Injury
Hypertension, Pulmonary
Lung Injury
Respiratory Distress Syndrome, Adult
Lung Diseases
Respiration Disorders
Respiratory Tract Diseases
Thoracic Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on September 03, 2015