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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Annette R. McClinton, United States Army Institute of Surgical Research
ClinicalTrials.gov Identifier:
NCT00351741
First received: July 11, 2006
Last updated: December 10, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention
Burns
Device: Ventilation - High Frequency Percussive Ventilation
Device: Ventilation - ARDSnet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: BEST (Burn Center Evaluation of Standard Therapies) Ventilator Mode Study: A Prospective Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by United States Army Institute of Surgical Research:

Primary Outcome Measures:
  • Ventilator-free Days During the First 28 Days [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    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:
  • Days Free From Nonpulmonary Organ Failure [ Time Frame: 28 ] [ Designated as safety issue: No ]
    days free from nonpulmonary organ failure as adapted from the ARDSnet study in the first 28 days.

  • Death [ Time Frame: during hospitalization ] [ Designated as safety issue: Yes ]
    In-hospital death.

  • Ventilator Associated Pneumonia [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    Those who develop both clinical and microscopic evidence of pulmonary infection while on the ventilator.

  • Need for Rescue Ventilator [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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


Enrollment: 62
Study Start Date: July 2006
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High Frequency
Provide standard ventilatory support for burn patients utilizing high frequency percussive ventilation
Device: Ventilation - High Frequency Percussive Ventilation
Ventilatory support delivering high frequency percussive ventilation using the Volumetric Diffusive Respirator
Other Names:
  • High Frequency Percussive Ventilation
  • Volumetric Diffusive Respirator
Active Comparator: Conventional
Standard ventilator support for non burned patients utilizing lung protective low tidal volume ventilation
Device: Ventilation - ARDSnet
Respiratory support with a conventional mode of ventilation using a conventional ventilator (Draeger Evita XL)
Other Names:
  • Lung Protective Ventilation
  • Low Tidal Volume Strategy
  • Conventional Mechanical Ventilation

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00351741

Locations
United States, Texas
United States Army Institute of Surgical Research
Fort Sam Houston, Texas, United States, 78234
Sponsors and Collaborators
United States Army Institute of Surgical Research
Investigators
Principal Investigator: Kevin K Chung, MD United States Army Insitute of Surgical Research
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Annette R. McClinton, Administrator, United States Army Institute of Surgical Research
ClinicalTrials.gov Identifier: NCT00351741     History of Changes
Other Study ID Numbers: H-06-005
Study First Received: July 11, 2006
Results First Received: July 16, 2010
Last Updated: December 10, 2012
Health Authority: United States: Federal Government

Keywords provided by United States Army Institute of Surgical Research:
Burns

Additional relevant MeSH terms:
Burns
Wounds and Injuries

ClinicalTrials.gov processed this record on October 23, 2014