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

Not Applicable
Terminated
Conditions
Burns
Interventions
Device: Ventilation - ARDSnet
Device: 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
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
ConventionalVentilation - ARDSnetStandard ventilator support for non burned patients utilizing lung protective low tidal volume ventilation
High FrequencyVentilation - High Frequency Percussive VentilationProvide standard ventilatory support for burn patients utilizing high frequency percussive ventilation
Primary Outcome Measures
NameTimeMethod
Ventilator-free Days During the First 28 Days28 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
NameTimeMethod
Ventilator Associated Pneumonia28 days

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

Need for Rescue Ventilator28 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 Failure28

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

Deathduring hospitalization

In-hospital death.

Barotrauma28 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

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