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

Study Overview
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Brief Summary
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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
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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.

Official Title
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BEST (Burn Center Evaluation of Standard Therapies) Ventilator Mode Study: A Prospective Randomized Controlled Trial

Conditions
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Burns

Intervention / Treatment
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* Device: Ventilation - High Frequency Percussive Ventilation
* Device: Ventilation - ARDSnet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who are deemed to require ventilatory support for more than 24 hours from the time of screening. Exclusion Criteria: Anticipated extubation within 24 hours of screening Patients who are pregnant Patients not expected to survive for more than 24 hours

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Frequency<br>Provide standard ventilatory support for burn patients utilizing high frequency percussive ventilation | Device: Ventilation - High Frequency Percussive Ventilation<br>* Ventilatory support delivering high frequency percussive ventilation using the Volumetric Diffusive Respirator<br>* Other names: Volumetric Diffusive Respirator;|
| Active Comparator: Conventional<br>Standard ventilator support for non burned patients utilizing lung protective low tidal volume ventilation | Device: Ventilation - ARDSnet<br>* Respiratory support with a conventional mode of ventilation using a conventional ventilator (Draeger Evita XL)<br>* Other names: Conventional Mechanical Ventilation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ventilator-free Days During the First 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. | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days Free From Nonpulmonary Organ Failure | days free from nonpulmonary organ failure as adapted from the ARDSnet study in the first 28 days. | 28 | 
| Death | In-hospital death. | during hospitalization | 
| Ventilator Associated Pneumonia | Those who develop both clinical and microscopic evidence of pulmonary infection while on the ventilator. | 28 days | 
| Need for Rescue Ventilator | 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. | 28 days | 
| Barotrauma | 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. | 28 days | 
| Ventilator Associated Tracheobronchitis (VATB) | 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 | checked daily | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Burns