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

Sponsored by:	United States Army Institute of Surgical Research
Information provided by:	United States Army Institute of Surgical Research
ClinicalTrials.gov Identifier:	NCT00351741

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: Ventilator Device: Ventilation

MedlinePlus related topics: Burns

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	BEST (Burn Center Evaluation of Standard Therapies) Ventilator Mode Study: A Prospective Randomized Controlled Trial

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

Primary Outcome Measures:

To assess differences in ventilator-free days during the first 28 days between two ventilator strategies. [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To determine the best means of providing ventilatory support for burn patients needing mechanical ventilation. [ Time Frame: as required by patient demands ] [ Designated as safety issue: No ]
To determine the best means of providing ventilatory support for burn patients with ARDS. [ Time Frame: When ventilatory support is no longer needed ] [ Designated as safety issue: No ]
To determine the true incidence of ventilator associated necrotizing tracheobronchitis (VANTB) [ Time Frame: checked daily ] [ Designated as safety issue: No ]
To determine the impact of specific ventilator mode on sedation and analgesic requirements in the first 28 days. [ Time Frame: Assess daily ] [ Designated as safety issue: No ]
To determine differences in the expression of inflammatory cytokines (TNF-alpha, Il-6) during the first week on ventilation. [ Time Frame: daily during the first week ] [ Designated as safety issue: No ]

Estimated Enrollment:	170
Study Start Date:	July 2006
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
High Frequency: Active Comparator Provide standard ventilatory support for burn patients	Device: Ventilator Continuous ventilatory support for burned patients
Conventional: Experimental Standard ventilator support for non burned patients	Device: Ventilation Continuous respiratory support

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

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

Contacts

Contact: Michelle Morrow, RN	210-916-8147	michelle.morrow@amedd.army.mil
Contact: Chaya Galin, RN	210-916-7154	chaya.galin@amedd.army.mil

Locations

United States, Texas
United States Army Institute of Surgical Research	Recruiting
Fort Sam Houston, Texas, United States, 78234
Contact: Annette R McClinton, RN, MA 210-916-2834 annette.mcclinton@amedd.army.mil
Contact: Lynn Platteborze, MS 210-916-9351 lynn.platteborze@amedd.army.mil
Principal Investigator: Kevin K Chung, MD

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:

Salim A, Martin M. High-frequency percussive ventilation. Crit Care Med. 2005 Mar;33(3 Suppl):S241-5. Review.

[No authors listed] Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. The Acute Respiratory Distress Syndrome Network. N Engl J Med. 2000 May 4;342(18):1301-8.

Responsible Party:	US Army Institute of Surgical Research ( Kevin Chung, MD )
Study ID Numbers:	H-06-005
Study First Received:	July 11, 2006
Last Updated:	July 24, 2008
ClinicalTrials.gov Identifier:	NCT00351741
Health Authority:	United States: Federal Government

Keywords provided by United States Army Institute of Surgical Research:

Burns

Study placed in the following topic categories:

Burns
Wounds and Injuries
Disorders of Environmental Origin

ClinicalTrials.gov processed this record on January 14, 2009