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NCT01681225 · ClinicalTrials.gov registry record · NA

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

A NA study, sponsored by Beth Israel Deaconess Medical Center.

Completed
Registry status
NA
Development phase
202
Enrollment target

NCT01681225: Completed NA study, sponsored by Beth Israel Deaconess Medical Center.

NCT01681225 is a NA study that has completed, run by Beth Israel Deaconess Medical Center. The registered enrollment target is 202 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01681225, a NA study, has completed, sponsored by Beth Israel Deaconess Medical Center.

COMPLETED
Registry status
NA
Development phase
202 participants
Enrollment target

Study Summary

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.

Primary Outcome

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 su

Interventions

  • OTHER Esophageal-pressure guided mechanical ventilation
  • OTHER High PEEP mechanical ventilation

Trial Details

FieldValue
Enrollment Target 202 participants
Start Date 2012-10-31
Est. Completion 2018-10-19
Phase NA

What the finished NCT01681225 record still lists

NCT01681225 is an interventional study that assigns participants to a tested intervention. The registered 202 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (86% lower).

The record links to 0 conditions, and to 2 interventions - of which Esophageal-pressure guided mechanical ventilation is the first listed.

NCT01681225 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01681225 about?

NCT01681225 is a clinical study titled "EPVent 2- A Phase II Study of Mechanical Ventilation Directed by Transpulmonary Pressures". 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) througho...

What is the current status of trial NCT01681225?

This trial is currently completed. It is a NA study. The enrollment target is 202 participants. The study started on 2012-10-31. Estimated completion is 2018-10-19.

What interventions are being tested in trial NCT01681225?

The interventions under investigation include: Esophageal-pressure guided mechanical ventilation (OTHER), High PEEP mechanical ventilation (OTHER).

Who is sponsoring clinical trial NCT01681225?

This trial is sponsored by Beth Israel Deaconess Medical Center, which has 488 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01681225's enrollment target sits among peer trials

202 505th of 2000 higher than 1,495 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01681225, the US trial registry maintained by the National Library of Medicine. NCT01681225 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.