Clinical trial NCT00351741: BEST (Burn Center Evaluation of Standard Therapies) Ventilator Mode Study-
Official title: BEST (Burn Center Evaluation of Standard Therapies) Ventilator Mode Study: A Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Burns
Keywords: Burns
Lead sponsor: United States Army Institute of Surgical Research
Sponsor class: FED
First posted: 2006-07-13
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: Ventilator-free Days During the First 28 Days
timeFrame: 28 days
Secondary outcomes:
measure: Days Free From Nonpulmonary Organ Failure
timeFrame: 28
measure: Death
timeFrame: during hospitalization
measure: Ventilator Associated Pneumonia
timeFrame: 28 days
measure: Need for Rescue Ventilator
timeFrame: 28 days
measure: Barotrauma
timeFrame: 28 days
measure: Ventilator Associated Tracheobronchitis (VATB)
timeFrame: checked daily
Other outcomes:
Locations:
city: Fort Sam Houston
country: United States
facility: United States Army Institute of Surgical Research
state: Texas
Study officials:
affiliation: United States Army Insitute of Surgical Research
name: Kevin K Chung, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.