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

United States Army Institute of Surgical Research62 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Burns

Interventions

Ventilation - High Frequency Percussive VentilationDEVICE

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

Ventilation - ARDSnetDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

United States Army Institute of Surgical Research

Fort Sam Houston, Texas, United States

Outcomes

Primary Outcomes

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.

Time frame: 28 days

Secondary Outcomes

Days Free From Nonpulmonary Organ Failure

days free from nonpulmonary organ failure as adapted from the ARDSnet study in the first 28 days.

Time frame: 28

Death

In-hospital death.

Time frame: during hospitalization

Ventilator Associated Pneumonia

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

Time frame: 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.

Time frame: 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.

Time frame: 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

Data from ClinicalTrials.gov

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