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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 is a NA study that was terminated before completion, run by Boston Medical Center. The registered enrollment target is 7 participants.
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
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2012-09 |
| Est. Completion | 2016-12-23 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01083277
The ClinicalTrials.gov registry entry for NCT01083277 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 7 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Medical Center, which has 253 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which variable ventilation is the first listed.
NCT01083277 reports 0 study locations.
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.
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