Variable Ventilation During Acute Respiratory Failure
|ClinicalTrials.gov Identifier: NCT01083277|
Recruitment Status : Terminated (Slow enrollment)
First Posted : March 9, 2010
Last Update Posted : July 11, 2017
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
|Condition or disease||Intervention/treatment||Phase|
|Acute Respiratory Failure||Device: variable ventilation Other: Conventional ventilation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Device Feasibility|
|Official Title:||Variable Ventilation During Acute Respiratory Failure|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||July 2016|
|Actual Study Completion Date :||December 23, 2016|
Experimental: variable ventilation
A novel means of conducting mechanical ventilation that involves an approximately 40% variation in tidal volume around a set mean tidal volume
Device: variable ventilation
In variable ventilation, the tidal volume on the Puritan-Bennett 840 ventilator will be randomly varied by 40% on a breath-by-breath basis around a pre-set mean, using the variable ventilation software developed by Dr. Bela Suki and Dr. Arnab Majumdar. In conventional ventilation, the tidal volume on the Puritan-Bennett 840 ventilator will be set to equal the mean tidal volume used in variable ventilation and does not vary.
This is the control arm of the study, in which tidal volume will be set as the patient's baseline tidal volume prior to study entry and will not vary.
Other: Conventional ventilation
tidal volume will be set as the patient's baseline tidal volume prior to study entry and will not vary.
- The occurrence of adverse events in the use of variable ventilation versus conventional ventilation, including the loss of any of the following (1) hemodynamic stability, (2) respiratory stability,(3) acid-base stability, and (4) neurological stability. [ Time Frame: Up to 24 hours after the end of the study period ]
- Oxygenation [ Time Frame: 3 hours ]PaO2
- Biomarkers of lung injury [ Time Frame: 3 hours ]IL6, IL8, IL1Ra, SP-D, sTNFaR I and II
- Lung mechanics [ Time Frame: 3 hours ]quasi static lung compliance, mean airway pressure, peak airway pressure, plateau pressure.
- Sedatives [ Time Frame: 3 hours ]need for increased sedative
- PaCO2 [ Time Frame: 3 hours ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01083277
|United States, Massachusetts|
|Boston Medical Center|
|Boston, Massachusetts, United States, 02118|
|Principal Investigator:||George T O'Connor, MD||Boston University|