Trial Outcomes & Findings for BEST (Burn Center Evaluation of Standard Therapies) Ventilator Mode Study- (NCT NCT00351741)

NCT ID: NCT00351741

Last Updated: 2015-09-21

Results Overview

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.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 62 participants
• Primary outcome timeframe: 28 days
• Results posted on: 2015-09-21

Participant Flow

After 3 yrs of enrollment, interim analysis revealed a significant number of subjects in the LTV arm required rescue, which served as the trigger to close the study to further enrollment. Between April 2006 and May 2009, 387 patients were screened for eligibility. 155 patients met criteria of which 62 were randomized, 31 in each arm.

Participant milestones

Measure	High Frequency Intervention with high frequency percussive ventilation	Conventional Low-tidal volume ventilation
Overall Study COMPLETED	31	31
Overall Study NOT COMPLETED	0	0
Overall Study STARTED	31	31

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	High Frequency n=31 Participants Intervention with high frequency percussive ventilation	Conventional n=31 Participants Low-tidal volume ventilation	Total n=62 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	29 Participants n=5 Participants	29 Participants n=7 Participants	58 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Age, Continuous	35 years STANDARD_DEVIATION 18 • n=5 Participants	37 years STANDARD_DEVIATION 18 • n=7 Participants	36 years STANDARD_DEVIATION 18 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants	26 Participants n=7 Participants	53 Participants n=5 Participants
Region of Enrollment United States	31 participants n=5 Participants	31 participants n=7 Participants	62 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	High Frequency n=31 Participants Intervention with high frequency percussive ventilation	Conventional n=31 Participants Low-tidal volume ventilation
Ventilator-free Days During the First 28 Days	12 Days Standard Deviation 9	11 Days Standard Deviation 9

SECONDARY outcome

Timeframe: 28

days free from nonpulmonary organ failure as adapted from the ARDSnet study in the first 28 days.

Outcome measures

Measure	High Frequency n=31 Participants Intervention with high frequency percussive ventilation	Conventional n=31 Participants Low-tidal volume ventilation
Days Free From Nonpulmonary Organ Failure	15 Days Standard Deviation 11	15 Days Standard Deviation 10

SECONDARY outcome

Timeframe: during hospitalization

In-hospital death.

Outcome measures

Measure	High Frequency n=31 Participants Intervention with high frequency percussive ventilation	Conventional n=31 Participants Low-tidal volume ventilation
Death	6 Participants	6 Participants

SECONDARY outcome

Timeframe: 28 days

Those who develop both clinical and microscopic evidence of pulmonary infection while on the ventilator.

Outcome measures

Measure	High Frequency n=31 Participants Intervention with high frequency percussive ventilation	Conventional n=31 Participants Low-tidal volume ventilation
Ventilator Associated Pneumonia	10 Participants	16 Participants

SECONDARY outcome

Timeframe: 28 days

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.

Outcome measures

Measure	High Frequency n=31 Participants Intervention with high frequency percussive ventilation	Conventional n=31 Participants Low-tidal volume ventilation
Need for Rescue Ventilator	2 Participants	9 Participants

SECONDARY outcome

Timeframe: 28 days

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.

Outcome measures

Measure	High Frequency n=31 Participants Intervention with high frequency percussive ventilation	Conventional n=31 Participants Low-tidal volume ventilation
Barotrauma	0 Participants	4 Participants

SECONDARY outcome

Timeframe: checked daily

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

Outcome measures

Measure	High Frequency n=31 Participants Intervention with high frequency percussive ventilation	Conventional n=31 Participants Low-tidal volume ventilation
Ventilator Associated Tracheobronchitis (VATB)	2 Participants	0 Participants

Adverse Events

High Frequency

Serious events: 10 serious events

Other events: 2 other events

Deaths: 0 deaths

Conventional

Serious events: 16 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	High Frequency n=31 participants at risk Intervention with high frequency percussive ventilation	Conventional n=31 participants at risk Low-tidal volume ventilation
Respiratory, thoracic and mediastinal disorders Barotrauma	0.00% 0/31 • 28 days Ventilator Associated Pneumonia	12.9% 4/31 • Number of events 4 • 28 days Ventilator Associated Pneumonia
Respiratory, thoracic and mediastinal disorders Ventilator Associtated Pneumonia	32.3% 10/31 • Number of events 10 • 28 days Ventilator Associated Pneumonia	51.6% 16/31 • Number of events 16 • 28 days Ventilator Associated Pneumonia

Other adverse events

Measure	High Frequency n=31 participants at risk Intervention with high frequency percussive ventilation	Conventional n=31 participants at risk Low-tidal volume ventilation
Respiratory, thoracic and mediastinal disorders Ventilator Associated Tracheobronchitis	6.5% 2/31 • Number of events 2 • 28 days Ventilator Associated Pneumonia	0.00% 0/31 • 28 days Ventilator Associated Pneumonia

Additional Information

Principal Investigator

USAISR

Phone: 210-916-3054

Email: kevin.chung@us.army.mil

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place