BEST (Burn Center Evaluation of Standard Therapies) Ventilator Mode Study-
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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 |
- 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.
- 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:
|
|
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:
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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 |
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| United States, Texas | |
| United States Army Institute of Surgical Research | |
| Fort Sam Houston, Texas, United States, 78234 | |
| 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 May 23, 2013