Lung Protective Ventilation in Pulmonary Thromboendarterectomy (PTE) Patients

NCT00747045 | Completed DMC

• 1 other identifier: 080721
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Thromboembolic Pulmonary Hypertension; Acute Lung Injury

Keywords

Chronic Thromboembolic Pulmonary Hypertension; Lung Injury; Ventilation Strategies

Outcome Measures

Primary Outcomes (1)

• Incidence of Reperfusion Lung Injury

  72 Hours

Secondary Outcomes (3)

• ICU free days

  28 days

• Hospital Free Days

  28 days

• Mortality

  28 Days

Study Arms (2)

Low tidal volume

EXPERIMENTAL

Tidal volume of 6 mL/Kg ideal body weight

Other: Ventilation Strategy

Usual care

ACTIVE COMPARATOR

Tidal volume of 10 mL/Kg ideal body weight

Other: Ventilation Strategy

Interventions

Ventilation Strategy OTHER

Comparison of low vs standard tidal volumes in patients undergoing PTE

Low tidal volume; Usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

UCSD - Thornton Hospital

La Jolla, California, 92037, United States

Location

Related Publications (1)

• 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.

  PMID: 26241077 DERIVED

MeSH Terms

Conditions

Acute Lung Injury; Lung Injury

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Thoracic Injuries; Wounds and Injuries

Study Officials

• Kim M Kerr, MD

  UCSD Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor of Medicine

Study Record Dates

• First Submitted: September 3, 2008
• First Posted: September 4, 2008
• Study Start: August 1, 2008
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: December 3, 2014

Record last verified: 2014-12

Locations

US (1)