EPVent 2- A Phase II Study of Mechanical Ventilation Directed by Transpulmonary Pressures (EPVent2)
|ClinicalTrials.gov Identifier: NCT01681225|
Recruitment Status : Active, not recruiting
First Posted : September 7, 2012
Last Update Posted : August 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Acute Respiratory Distress Syndrome||Other: Esophageal-pressure guided mechanical ventilation Other: High PEEP mechanical ventilation||Not Applicable|
This phase II prospective randomized controlled trial of ventilation directed by esophageal pressure measurements will enroll 200 patients with moderate to severe ARDS by the Berlin conference definition in several academic medical centers in North America. The control group will be ventilated using an alternative high-PEEP strategy with PEEP and FiO2 set using to an empiric table.
Plasma samples will be obtained at enrollment and days 3 and 7 and assessed for a variety of lung injury biomarkers to better assess the association between our intervention and the inflammation associated with mechanical ventilation and the development of ARDS. Hospital survivors will undergo a brief follow up phone survey to assess survival, functional status (Barthel Index), health-related QOL (Short Form 12), and frailty (VES) twelve months after enrollment.
The study length will be six years with a six month start-up period followed by a planned 50 month enrollment and twelve month follow-up.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||202 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||EPVent 2- A Phase II Study of Mechanical Ventilation Directed by Transpulmonary Pressures (EPVent2)|
|Actual Study Start Date :||October 31, 2012|
|Actual Primary Completion Date :||October 12, 2017|
|Estimated Study Completion Date :||September 14, 2018|
The overall goals for the "EPVent" group (esophageal-pressure guided mechanical ventilation) are to employ an open-lung strategy that includes low tidal volumes and maintenance of a positive transpulmonary pressure at end-expiration [Ptpexp]. Fraction of inspired oxygen [FiO2] and transpulmonary pressure pressure during an expiratory hold will be changed to achieve values shown in one of the columns of a protocol-specified table to meet the oxygenation target.
Other: Esophageal-pressure guided mechanical ventilation
Active Comparator: Control
The overall goals for the Control group are similar to those for the EPVent group: to employ an open-lung strategy that includes low tidal volumes using an alternative high positive end-expiratory pressure [PEEP] strategy. The control group PEEP and tidal volume will be managed without reference to the esophageal pressure measurements, and instead will follow an empiric high PEEP mechanical ventilation strategy. PEEP and FiO2 will be raised or lowered to achieve the oxygenation target level specified in a study table.
Other: High PEEP mechanical ventilation
- A composite outcome of mortality and time off the ventilator at 28-days. [ Time Frame: Day 28 ]The trial will utilize a primary composite endpoint that incorporates death and days off the ventilator at 28 days in such a manner that death constitutes a more serious outcome. Every subject is compared to every other subject in the trial and assigned one number resulting from each comparison. Since mortality outcome is clinically more important, mortality takes precedence over days off the ventilator. The sum of scores for patients in the treatment group is compared to the sum of scores of subjects in the control group to form a test statistic by the Mann-Whitney technique.
- Ventilator free days to day 28 [ Time Frame: Day 28 ]Number of calendar days breathing unassisted.
- mortality [ Time Frame: Day 60 ]Hospital and ICU mortality to day 60
- lengths of stay [ Time Frame: Day 60 ]Hospital and ICU lengths of stay to days 28 and 60
- biomarkers of lung injury [ Time Frame: Day 7 ]Plasma biomarkers of lung injury on enrollment and days 3 and 7 after enrollment
- Survival [ Time Frame: 1 year ]Mortality to 1 year
- Need for rescue therapy [ Time Frame: Day 28 ]Rescue measures will be chosen according to the practice at the clinical site, and may include repeated recruitment maneuvers, prone positioning, nitric oxide, epoprostenol sodium, airway pressure release ventilation, high frequency ventilation, or ECMO.
- Activities of daily living [ Time Frame: 1 year ]Will assess via questionnaire (Barthel Index) done by phone at 1 year. Barthel Index scores range from 0-100, with 100 representing greatest independence of activities of daily living.
- Self-reported health assessment [ Time Frame: 1 year ]Will assess via questionnaire (12-Item Short-Form Health Survey [SF-12]) done by phone at 1 year. The SF-12 scores range from 0-100 points, with higher scores representing the highest level of health.
- Frailty in patients age 65 and older [ Time Frame: 1 year ]Will assess via questionnaire (Vulnerable Elders-13 Survey) done by phone at 1 year. VES scores range from 0-10 points, with higher scores representing greater risk.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01681225
|United States, California|
|University of California at San Diego|
|La Jolla, California, United States, 92093|
|Stanford University Medical Center|
|Stanford, California, United States, 94305|
|United States, Florida|
|Orlando, Florida, United States, 32806|
|United States, Maryland|
|Shock-Trauma University of Maryland Medical Center|
|Baltimore, Maryland, United States, 21201|
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|University of Massachusets Medical Center|
|Worcester, Massachusetts, United States, 01655|
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48109|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|United States, New York|
|Montefiore Medical Center|
|Bronx, New York, United States, 10467|
|Canada, British Columbia|
|Vancouver General Hospital|
|Vancouver, British Columbia, Canada|
|St Joseph's Healthcare|
|Hamilton, Ontario, Canada, L8N 4A6|
|University Health Network|
|Toronto, Ontario, Canada, M5G 2C4|
|Quebec City, Quebec, Canada, G1V 4G5|
|Principal Investigator:||Daniel S Talmor, MD, MPH||Beth Israel Deaconess Medical Center|