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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

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 Summary: 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.
Sponsor: United States Army Institute of Surgical Research

Current Primary Outcome: Ventilator-free Days During the First 28 Days [ Time Frame: 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.


Original Primary Outcome: To assess differences in ventilator-free days during the first 28 days between two ventilator strategies.

Current Secondary Outcome:

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


Original Secondary Outcome:

  • To determine the best means of providing ventilatory support for burn patients needing mechanical ventilation.
  • To determine the best means of providing ventilatory support for burn patients with ARDS.
  • To determine the true incidence of ventilator associated necrotizing tracheobronchitis (VANTB)
  • To determine the impact of specific ventilator mode on sedation and analgesic requirements in the first 28 days.
  • To determine differences in the expression of inflammatory cytokines (TNF-alpha, Il-6) during the first week on ventilation.


Information By: United States Army Institute of Surgical Research

Dates:
Date Received: July 11, 2006
Date Started: July 2006
Date Completion:
Last Updated: September 8, 2015
Last Verified: September 2015