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

Burns Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00351741
• Other study ID #: H-06-005
• Status: Terminated
• Phase: N/A
• First received: July 11, 2006
• Last updated: September 8, 2015
• Start date: July 2006
• Est. completion date: February 2010

Study information

• Verified date: September 2015
• Source: United States Army Institute of Surgical Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 62
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Burns

Intervention

Device:
• Ventilation - High Frequency Percussive Ventilation
Ventilatory support delivering high frequency percussive ventilation using the Volumetric Diffusive Respirator
• Ventilation - ARDSnet
Respiratory support with a conventional mode of ventilation using a conventional ventilator (Draeger Evita XL)

Locations

Country	Name	City	State
United States	United States Army Institute of Surgical Research	Fort Sam Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
United States Army Institute of Surgical Research

Country where clinical trial is conducted

United States, 

References & Publications (2)

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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Days Free From Nonpulmonary Organ Failure	days free from nonpulmonary organ failure as adapted from the ARDSnet study in the first 28 days.	28	No
Secondary	Death	In-hospital death.	during hospitalization	Yes
Secondary	Ventilator Associated Pneumonia	Those who develop both clinical and microscopic evidence of pulmonary infection while on the ventilator.	28 days	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes