BEST (Burn Center Evaluation of Standard Therapies) Ventilator Mode Study-
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|ClinicalTrials.gov Identifier: NCT00351741|
Recruitment Status : Terminated
First Posted : July 13, 2006
Results First Posted : December 28, 2010
Last Update Posted : September 21, 2015
The purpose of this study is to compare High Frequency Pressure Ventilation (HFPV) to conventional mechanical ventilation.
Hypothesis: Patients placed on HFPV will have significantly higher number of ventilator-free days compared to patients placed on a conventional volume mode.
|Condition or disease||Intervention/treatment||Phase|
|Burns||Device: Ventilation - High Frequency Percussive Ventilation Device: Ventilation - ARDSnet||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||62 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||BEST (Burn Center Evaluation of Standard Therapies) Ventilator Mode Study: A Prospective Randomized Controlled Trial|
|Study Start Date :||July 2006|
|Actual Primary Completion Date :||February 2010|
|Actual Study Completion Date :||February 2010|
Experimental: High Frequency
Provide standard ventilatory support for burn patients utilizing high frequency percussive ventilation
Device: Ventilation - High Frequency Percussive Ventilation
Ventilatory support delivering high frequency percussive ventilation using the Volumetric Diffusive Respirator
Active Comparator: Conventional
Standard ventilator support for non burned patients utilizing lung protective low tidal volume ventilation
Device: Ventilation - ARDSnet
Respiratory support with a conventional mode of ventilation using a conventional ventilator (Draeger Evita XL)
- Ventilator-free Days During the First 28 Days [ Time Frame: 28 days ]The primary end point was ventilator-free days in the first 28 days, defined as the number of days after randomization from day 0 to day 28 alive without ventilator assistance for at least 48 consecutive hrs.
- Days Free From Nonpulmonary Organ Failure [ Time Frame: 28 ]days free from nonpulmonary organ failure as adapted from the ARDSnet study in the first 28 days.
- Death [ Time Frame: during hospitalization ]In-hospital death.
- Ventilator Associated Pneumonia [ Time Frame: 28 days ]Those who develop both clinical and microscopic evidence of pulmonary infection while on the ventilator.
- Need for Rescue Ventilator [ Time Frame: 28 days ]Subjects who did not meet predetermined oxygenation and ventilation goals on the study mode despite ventilator- specific optimization were switched to a rescue mode of ventilation.
- Barotrauma [ Time Frame: 28 days ]Defined as a new pneumothorax, pneumomediastinum, subcutaneous emphysema, interstitial emphysema, or pneumatocele >2 cm in diameter not associated with a vascular procedure, lung biopsy, or thoracentesis.
- Ventilator Associated Tracheobronchitis (VATB) [ Time Frame: checked daily ]Defined as carinal or mainstem airway friability and sloughing with associated bleeding. Only diagnosed after the patient had spent at least 7 days on the assigned ventilator mode and had not been diagnosed with inhalation injury on admission
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00351741
|United States, Texas|
|United States Army Institute of Surgical Research|
|Fort Sam Houston, Texas, United States, 78234|
|Principal Investigator:||Kevin K Chung, MD||United States Army Insitute of Surgical Research|