BEST (Burn Center Evaluation of Standard Therapies) Ventilator Mode Study-
|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
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|