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NCT01083277 · ClinicalTrials.gov registry record · NA

Variable Ventilation During Acute Respiratory Failure

A NA study, sponsored by Boston Medical Center.

Terminated
Registry status
NA
Development phase
7
Enrollment target

NCT01083277: Clinical Trial NA study, sponsored by Boston Medical Center.

NCT01083277 is a NA study that was terminated before completion, run by Boston Medical Center. The registered enrollment target is 7 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01083277, a NA study, was terminated before completion, sponsored by Boston Medical Center.

TERMINATED
Registry status
NA
Development phase
7 participants
Enrollment target

Study Summary

Acute respiratory failure requiring support with mechanical ventilation occurs with an incidence of 77-100 per 100,000 person-years and accounts for half of all patients admitted to the intensive care unit. Major causes of acute respiratory failure include pneumonia, asthma, emphysema, and acute lung injury. These causes of acute respiratory failure may result in partial lung collapse (atelectasis), and airway narrowing (bronchoconstriction)that result in decreased oxygen levels requiring support with the ventilator. The prolonged inactivity in the supine position associated with mechanical ventilation can further result in atelectasis requiring increased oxygen supplementation through the ventilator. The current standard of care in acute respiratory failure is a strategy of mechanical ventilation using a single lung volume delivered repeatedly. However, the current standard mechanical ventilation strategy is not consistent with the variability in respiration of healthy humans and has been shown to contribute to increased lung injury in some studies. The mortality associated with acute respiratory failure is high, 30-40%. Thus, improvements in mechanical ventilation strategies that improve oxygen levels and potentially decrease further lung injury delivered by the ventilator are warranted. Recent studies by BU Professor Bela Suki and others in humans and animals with acute lung injury, bronchoconstriction, and atelectasis have shown that varying the lung volumes delivered by a ventilator significantly decreases biomarkers of lung injury, improves lung mechanics, and increases oxygenation when compared to identical mean volumes of conventional, monotonous low lung volume ventilation. Therefore, we propose a first-in-human, Phase I study to evaluate the safety of this novel mode of ventilation, Variable Ventilation, during acute respiratory failure

Interventions

  • DEVICE variable ventilation
  • OTHER Conventional ventilation

Trial Details

FieldValue
Enrollment Target 7 participants
Start Date 2012-09
Est. Completion 2016-12-23
Phase NA
Boston Medical Center

253 total trials

Why NCT01083277 stopped before completion

NCT01083277 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).

The record links to 0 conditions, and to 2 interventions - of which variable ventilation is the first listed.

NCT01083277 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01083277 about?

NCT01083277 is a clinical study titled "Variable Ventilation During Acute Respiratory Failure". Acute respiratory failure requiring support with mechanical ventilation occurs with an incidence of 77-100 per 100,000 person-years and accounts for half of all patients admitted to the intensive care unit. Major causes of acute respiratory failure include pneumonia, asthma, emphysema, and acute lun...

What is the current status of trial NCT01083277?

This trial is currently terminated. It is a NA study. The enrollment target is 7 participants. The study started on 2012-09. Estimated completion is 2016-12-23.

What interventions are being tested in trial NCT01083277?

The interventions under investigation include: variable ventilation (DEVICE), Conventional ventilation (OTHER).

Who is sponsoring clinical trial NCT01083277?

This trial is sponsored by Boston Medical Center, which has 253 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01083277's enrollment target sits among peer trials

7 1982nd of 2000 higher than 18 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 NCT01083277, the US trial registry maintained by the National Library of Medicine. NCT01083277 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.