BEST (Burn Center Evaluation of Standard Therapies) Ventilator Mode Study-
- Conditions
- Burns
- Interventions
- Device: Ventilation - ARDSnetDevice: Ventilation - High Frequency Percussive Ventilation
- Registration Number
- NCT00351741
- Lead Sponsor
- United States Army Institute of Surgical Research
- Brief Summary
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.
- Detailed Description
This is a prospective, randomized, controlled trial comparing HFPV to conventional ventilator modes in the support of burn patients with respiratory failure. Burn patients who develop the need for mechanical ventilation present a variety of challenges that call for innovative therapeutic options. Even in the absence of smoke inhalation injury,decreased chest wall compliance from full thickness burns as well as massive fluid requirements are just a few variables that make it difficult to achieve gas exchange goals when attempting to apply conventional lung protective strategies recommended by the ARDS Net investigators.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 62
- Patients who are deemed to require ventilatory support for more than 24 hours from the time of screening.
- Anticipated extubation within 24 hours of screening
- Patients who are pregnant Patients not expected to survive for more than 24 hours
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Conventional Ventilation - ARDSnet Standard ventilator support for non burned patients utilizing lung protective low tidal volume ventilation High Frequency Ventilation - High Frequency Percussive Ventilation Provide standard ventilatory support for burn patients utilizing high frequency percussive ventilation
- Primary Outcome Measures
Name Time Method Ventilator-free Days During the First 28 Days 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.
- Secondary Outcome Measures
Name Time Method Ventilator Associated Pneumonia 28 days Those who develop both clinical and microscopic evidence of pulmonary infection while on the ventilator.
Need for Rescue Ventilator 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.
Days Free From Nonpulmonary Organ Failure 28 days free from nonpulmonary organ failure as adapted from the ARDSnet study in the first 28 days.
Death during hospitalization In-hospital death.
Barotrauma 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) 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
Trial Locations
- Locations (1)
United States Army Institute of Surgical Research
🇺🇸Fort Sam Houston, Texas, United States