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EPVent 2- A Phase II Study of Mechanical Ventilation Directed by Transpulmonary Pressures (EPVent2)

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ClinicalTrials.gov Identifier: NCT01681225
Recruitment Status : Active, not recruiting
First Posted : September 7, 2012
Last Update Posted : November 1, 2017
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Daniel Talmor, Beth Israel Deaconess Medical Center

September 5, 2012
September 7, 2012
November 1, 2017
October 31, 2012
October 12, 2017   (Final data collection date for primary outcome measure)
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 in the treatment group is compared to every subject in the control group and assigned one number resulting from each comparison. Since mortality outcome is clinically more important, mortality takes precedence over days off the ventilator. These scores are summed up to obtain a cumulative score for each subject. The cumulative scores are added up for each treatment group to form a test statistic by the Mann-Whitney technique.
Same as current
Complete list of historical versions of study NCT01681225 on ClinicalTrials.gov Archive Site
  • Ventilator free days to day 28 [ Time Frame: Day 28 ]
  • mortality [ Time Frame: Day 60 ]
    Hospital and ICU mortality to days 28 and 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 ]
  • Quality of life [ Time Frame: 1 year ]
    Will assess via questionnaires (SF-12, Barthel Index, VES-13) done by phone at 12 months
  • 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.
Same as current
Not Provided
Not Provided
 
EPVent 2- A Phase II Study of Mechanical Ventilation Directed by Transpulmonary Pressures
EPVent 2- A Phase II Study of Mechanical Ventilation Directed by Transpulmonary Pressures (EPVent2)
This phase II multi-centered, randomized controlled trial of mechanical ventilation directed by esophageal pressure measurement will test the primary hypothesis that using a strategy of maintaining a minimal but positive transpulmonary pressure (Ptp = airway pressure minus pleural pressure) throughout the ventilatory cycle will lead to an improvement in patient survival.

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.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Acute Respiratory Distress Syndrome
  • Other: Esophageal-pressure guided mechanical ventilation
    Other Names:
    • mechanical ventilation strategy
    • open-lung strategy
    • EPVent
    • positive transpulmonary pressure at end-expiration
  • Other: High PEEP mechanical ventilation
  • Experimental: EPVent
    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.
    Intervention: 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.
    Intervention: Other: High PEEP mechanical ventilation

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
202
200
September 14, 2018
October 12, 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Acute onset of ARDS as defined by the Berlin Consensus Conference definitions:

    1. Hypoxemic respiratory failure with PaO2 / FIO2 ratio < 200 mmHg
    2. b) Bilateral alveolar/interstitial infiltrates on chest x-ray, with opacities not present for more than 7 days
    3. Respiratory failure not fully explained by cardiac failure or fluid overload
    4. Intubation on controlled ventilation and receiving PEEP ≥ 5 cm H2O
  • Age 16 years or older
  • Duration of ARDS 36 hours or less from meeting final Berlin criterion.

Exclusion Criteria:

  • Received mechanical ventilation more than 96 hours
  • Recently treated or bleeding varices, esophageal stricture, hematemesis, esophageal trauma, recent esophageal surgery or other contraindication for nasogastric tube placement
  • Severe coagulopathy (platelet count < 5000/microliter or INR > 4)
  • History of lung transplantation
  • Elevated intracranial pressure or conditions where hypercapnia-induced elevations in intracranial pressure should be avoided
  • Evidence of active air leak from the lung
  • not committed to full support
  • Participation in other intervention trials for ARDS or for sepsis within the past 30 days.
  • Neuromuscular disease that impairs ability to ventilate spontaneously
  • Severe chronic liver disease, defined as Child-Pugh Score of ≥12
  • Treating clinician refusal, or unwillingness to commit to controlled ventilation for at least 24 hours
  • Inability to get informed consent from the patient or surrogate.
  • Use of rescue therapies for prior to enrollment (e.g. nitric oxide, ECMO, prone positioning, high frequency oscillation). This does not exclude cases where these therapies were used as the initial mode of ventilation
Sexes Eligible for Study: All
16 Years and older   (Child, Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
 
 
NCT01681225
2009P000374
UM1HL108724 ( U.S. NIH Grant/Contract )
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Daniel Talmor, Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Daniel S Talmor, MD, MPH Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center
October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP