BurnsNCT00351741
BEST (Burn Center Evaluation of Standard Therapies) Ventilator Mode Study-
A study testing Ventilation - High Frequency Percussive Ventilation and Ventilation - ARDSnet in people with Burns, run by United States Army Institute of Surgical Research at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burns
- What is being tested?
- Ventilation - High Frequency Percussive Ventilation and Ventilation - ARDSnet
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to Feb 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are deemed to require ventilatory support for more than 24 hours from the time of screening.
Who cannot join
- Anticipated extubation within 24 hours of screening
- Patients who are pregnant Patients not expected to survive for more than 24 hours
Trial locations and contacts
1 site in 1 country.
United States1 site
United States Army Institute of Surgical Research
Fort Sam Houston, Texas, 78234
About this study
Official title: BEST (Burn Center Evaluation of Standard Therapies) Ventilator Mode Study: A Prospective Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Burns
- Being tested
- Ventilation - High Frequency Percussive Ventilation, Ventilation - ARDSnet
- Keywords
- Burns
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ventilation - High Frequency Percussive VentilationDevice
Also called High Frequency Percussive Ventilation, Volumetric Diffusive Respirator
Ventilatory support delivering high frequency percussive ventilation using the Volumetric Diffusive Respirator
Ventilation - ARDSnetDevice
Also called Lung Protective Ventilation, Low Tidal Volume Strategy, Conventional Mechanical Ventilation
Respiratory support with a conventional mode of ventilation using a conventional ventilator (Draeger Evita XL)
| Study group | Role | What they receive |
|---|---|---|
| High Frequency | Experimental | Provide standard ventilatory support for burn patients utilizing high frequency percussive ventilation Receives: Device: Ventilation - High Frequency Percussive Ventilation |
| Conventional | Active comparator | Standard ventilator support for non burned patients utilizing lung protective low tidal volume ventilation Receives: Device: Ventilation - ARDSnet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 days
Secondary outcomes (6)
Days Free From Nonpulmonary Organ Failure
days free from nonpulmonary organ failure as adapted from the ARDSnet study in the first 28 days.
Measured: 28
Death
In-hospital death.
Measured: during hospitalization
Ventilator Associated Pneumonia
Those who develop both clinical and microscopic evidence of pulmonary infection while on the ventilator.
Measured: 28 days
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.
Measured: 28 days
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.
Measured: 28 days
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
Measured: checked daily
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2006 (estimated)
- Study startJul 2006
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for BurnsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- United States Army Institute of Surgical Research
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Elsa Coates, United States Army Institute of Surgical Research
- Investigators
- Kevin K Chung, MD, Principal investigator, United States Army Insitute of Surgical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00351741
- Sponsor's protocol ID
- H-06-005
- Status last verified
- Sep 2015
- First submitted
- 11 Jul 2006
- Last updated
- 21 Sep 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 15753734Acute 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.
PubMed 10793162Chung 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.
PubMed 20639746
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BEST (Burn Center Evaluation of Standard Therapies) Ventilator Mode Study: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00351741
- Acronym / sponsor ID
- H-06-005
- Conditions
- Burns
- Keywords
- Burns
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 62 participants (actual)
- Lead sponsor
- United States Army Institute of Surgical ResearchUS federal agency
- Study start
- Jul 2006
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 13 Jul 2006 (estimated)
- Results
- Posted 28 Dec 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Frequency | Experimental | Device: Ventilation - High Frequency Percussive VentilationProvide standard ventilatory support for burn patients utilizing high frequency percussive ventilation |
| Conventional | Active comparator | Device: Ventilation - ARDSnetStandard ventilator support for non burned patients utilizing lung protective low tidal volume ventilation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who are deemed to require ventilatory support for more than 24 hours from the time of screening.
Key exclusion criteria (2 listed)
- Anticipated extubation within 24 hours of screening
- Patients who are pregnant Patients not expected to survive for more than 24 hours
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ventilation - High Frequency Percussive VentilationAlso: High Frequency Percussive Ventilation, Volumetric Diffusive RespiratorVentilatory support delivering high frequency percussive ventilation using the Volumetric Diffusive Respirator | Device | High Frequency |
| Ventilation - ARDSnetAlso: Lung Protective Ventilation, Low Tidal Volume Strategy, Conventional Mechanical VentilationRespiratory support with a conventional mode of ventilation using a conventional ventilator (Draeger Evita XL) | Device | Conventional |
Primary outcome
Ventilator-free Days During the First 28 Days
Time frame: 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.
6 secondary outcomes
Days Free From Nonpulmonary Organ Failure
Time frame: 28
Death
Time frame: during hospitalization
Ventilator Associated Pneumonia
Time frame: 28 days
Need for Rescue Ventilator
Time frame: 28 days
Barotrauma
Time frame: 28 days
Ventilator Associated Tracheobronchitis (VATB)
Time frame: checked daily
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15753734Salim 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.
- Background: PubMed 10793162Acute 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.
- Derived from this study: PubMed 20639746Chung 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin K Chung, MD principal investigator
United States Army Insitute of Surgical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ventilation - High Frequency Percussive Ventilation and Ventilation - ARDSnet in people with Burns, run by United States Army Institute of Surgical Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Dec 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventilator-free Days During the First 28 Days (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00351741, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2015.