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

U

United States Army Institute of Surgical Research

Status

Terminated

Conditions

Burns

Treatments

Device: Ventilation - ARDSnet
Device: Ventilation - High Frequency Percussive Ventilation

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT00351741
H-06-005

Details and patient eligibility

About

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.

Full 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.

Enrollment

62 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

62 participants in 2 patient groups

High Frequency
Experimental group
Description:
Provide standard ventilatory support for burn patients utilizing high frequency percussive ventilation
Treatment:
Device: Ventilation - High Frequency Percussive Ventilation
Conventional
Active Comparator group
Description:
Standard ventilator support for non burned patients utilizing lung protective low tidal volume ventilation
Treatment:
Device: Ventilation - ARDSnet

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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