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

NCT ID: NCT00351741

Last Updated: 2015-09-21

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2010-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Burns

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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High Frequency

Provide standard ventilatory support for burn patients utilizing high frequency percussive ventilation

Group Type EXPERIMENTAL

Ventilation - High Frequency Percussive Ventilation

Intervention Type DEVICE

Ventilatory support delivering high frequency percussive ventilation using the Volumetric Diffusive Respirator

Conventional

Standard ventilator support for non burned patients utilizing lung protective low tidal volume ventilation

Group Type ACTIVE_COMPARATOR

Ventilation - ARDSnet

Intervention Type DEVICE

Respiratory support with a conventional mode of ventilation using a conventional ventilator (Draeger Evita XL)

Interventions

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Ventilation - High Frequency Percussive Ventilation

Ventilatory support delivering high frequency percussive ventilation using the Volumetric Diffusive Respirator

Intervention Type DEVICE

Ventilation - ARDSnet

Respiratory support with a conventional mode of ventilation using a conventional ventilator (Draeger Evita XL)

Intervention Type DEVICE

Other Intervention Names

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High Frequency Percussive Ventilation Volumetric Diffusive Respirator Lung Protective Ventilation Low Tidal Volume Strategy Conventional Mechanical Ventilation

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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United States Army Institute of Surgical Research

FED

Sponsor Role lead

Responsible Party

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Elsa Coates

Administrator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kevin K Chung, MD

Role: PRINCIPAL_INVESTIGATOR

United States Army Insitute of Surgical Research

Locations

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United States Army Institute of Surgical Research

Fort Sam Houston, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 15753734 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10793162 (View on PubMed)

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.

Reference Type DERIVED
PMID: 20639746 (View on PubMed)

Other Identifiers

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H-06-005

Identifier Type: -

Identifier Source: org_study_id

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