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

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

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.

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.

Provide standard ventilatory support for burn patients utilizing high frequency percussive ventilation

Standard ventilator support for non burned patients utilizing lung protective low tidal volume ventilation

Ventilatory support delivering high frequency percussive ventilation using the Volumetric Diffusive Respirator

Respiratory support with a conventional mode of ventilation using a conventional ventilator (Draeger Evita XL)

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.

Those who develop both clinical and microscopic evidence of pulmonary infection while on the 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.

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.

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

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

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Acute Respiratory Distress Syndrome Network; Brower RG, Matthay MA, Morris A, Schoenfeld D, Thompson BT, Wheeler A. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med. 2000 May 4;342(18):1301-8. doi: 10.1056/NEJM200005043421801.

Chung KK, Wolf SE, Renz EM, Allan PF, Aden JK, Merrill GA, Shelhamer MC, King BT, White CE, Bell DG, Schwacha MG, Wanek SM, Wade CE, Holcomb JB, Blackbourne LH, Cancio LC. High-frequency percussive ventilation and low tidal volume ventilation in burns: a randomized controlled trial. Crit Care Med. 2010 Oct;38(10):1970-7. doi: 10.1097/CCM.0b013e3181eb9d0b.