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NCT01038531 · ClinicalTrials.gov registry record · NA
Biomarkers of Lung Injury With Low Tidal Volume Ventilation Compared With Airway Pressure Release Ventilation
A NA study, sponsored by Boston Medical Center.
- Terminated
- Registry status
- NA
- Development phase
- 3
- Enrollment target
NCT01038531 is a NA study that was terminated before completion, run by Boston Medical Center. The registered enrollment target is 3 participants.
The verdict
NCT01038531, a NA study, was terminated before completion, sponsored by Boston Medical Center.
- TERMINATED
- Registry status
- NA
- Development phase
- 3 participants
- Enrollment target
Study Summary
Acute lung injury (ALI) and the acute respiratory distress syndrome (ARDS) represent a spectrum of clinical syndromes of rapid respiratory system deterioration that are associated with both pulmonary and systemic illness. These syndromes are associated with 30-40% mortality with our current standard of care and are responsible for approximately 75,000 deaths in the US yearly. Current evidence-based care of ALI consists of a strategy of mechanical ventilation utilizing low lung volumes (ARDSNet ventilation) intended to limit further stretch-induced lung injury exacerbated by the ventilator. However, this strategy has been shown to be associated with increased lung injury in a subset of patients and still is associated with about a 30% mortality rate. Airway pressure release ventilation (APRV) is a different, non-experimental strategy of mechanical ventilation currently in routine clinical use. APRV is a pressure-cycled ventilator mode that allows a patient a greater degree of autonomy in controlling his or her breathing pattern than ARDSNet ventilation. Use of APRV has been associated with better oxygenation, less sedative usage, and less ventilator-associated pneumonia in small studies compared with other ventilator modes. However, debate exists over whether APRV might result in decreased or increased ventilator-associated lung injury when compared with ARDSNet ventilation. We intend to implement a randomized, cross over study looking at biomarkers of lung injury in patients with acute lung injury during ventilation with APRV and using the ARDSNet protocol. Our hypothesis is that airway pressure release ventilation is associated with lower levels of lung injury biomarkers than ARDSNet ventilation.
Interventions
- OTHER low-tidal-volume ventilation
- OTHER APRV
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2010-07 |
| Est. Completion | 2016-09 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01038531
The ClinicalTrials.gov registry entry for NCT01038531 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 3 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 low-tidal-volume ventilation is the first listed.
NCT01038531 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01038531 about?
NCT01038531 is a clinical study titled "Biomarkers of Lung Injury With Low Tidal Volume Ventilation Compared With Airway Pressure Release Ventilation". Acute lung injury (ALI) and the acute respiratory distress syndrome (ARDS) represent a spectrum of clinical syndromes of rapid respiratory system deterioration that are associated with both pulmonary and systemic illness. These syndromes are associated with 30-40% mortality with our current standard...
What is the current status of trial NCT01038531?
This trial is currently terminated. It is a NA study. The enrollment target is 3 participants. The study started on 2010-07. Estimated completion is 2016-09.
What interventions are being tested in trial NCT01038531?
The interventions under investigation include: low-tidal-volume ventilation (OTHER), APRV (OTHER).
Who is sponsoring clinical trial NCT01038531?
This trial is sponsored by Boston Medical Center, which has 253 total clinical trials registered on ClinicalTrials.gov.
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