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

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

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.

Study Overview

• Status: Terminated
• Conditions: Burns
• Intervention / Treatment: Device: Ventilation - High Frequency Percussive Ventilation; Device: Ventilation - ARDSnet

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.

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Fort Sam Houston, Texas, United States, 78234
      • United States Army Institute of Surgical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Days Free From Nonpulmonary Organ Failure	days free from nonpulmonary organ failure as adapted from the ARDSnet study in the first 28 days.	28
Death	In-hospital death.	during hospitalization
Ventilator Associated Pneumonia	Those who develop both clinical and microscopic evidence of pulmonary infection while on the ventilator.	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.	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.	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	checked daily

Collaborators and Investigators

• Sponsor: United States Army Institute of Surgical Research
• Investigators: Principal Investigator: Kevin K Chung, MD, United States Army Insitute of Surgical Research

Publications and helpful links

General Publications

• Acute Respiratory Distress Syndrome Network; Brower RG, Matthay MA, Morris A, Schoenfeld D, Thompson BT, Wheeler A. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med. 2000 May 4;342(18):1301-8. doi: 10.1056/NEJM200005043421801.
• Salim A, Martin M. High-frequency percussive ventilation. Crit Care Med. 2005 Mar;33(3 Suppl):S241-5. doi: 10.1097/01.ccm.0000155921.32083.ce.
• Chung KK, Wolf SE, Renz EM, Allan PF, Aden JK, Merrill GA, Shelhamer MC, King BT, White CE, Bell DG, Schwacha MG, Wanek SM, Wade CE, Holcomb JB, Blackbourne LH, Cancio LC. High-frequency percussive ventilation and low tidal volume ventilation in burns: a randomized controlled trial. Crit Care Med. 2010 Oct;38(10):1970-7. doi: 10.1097/CCM.0b013e3181eb9d0b.

Study record dates

Study Major Dates

• Study Start: July 1, 2006
• Primary Completion (ACTUAL): February 1, 2010
• Study Completion (ACTUAL): February 1, 2010

Study Registration Dates

• First Submitted: July 11, 2006
• First Submitted That Met QC Criteria: July 11, 2006
• First Posted (ESTIMATE): July 13, 2006

Study Record Updates

• Last Update Posted (ESTIMATE): September 21, 2015
• Last Update Submitted That Met QC Criteria: September 8, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: Burns
• Additional Relevant MeSH Terms: Wounds and Injuries; Burns
• Other Study ID Numbers: H-06-005