Acute Respiratory Distress SyndromeNCT00813371
Airway Pressure Release Ventilation as a Preventative Strategy
A study testing Airway Pressure Release Ventilation and ARDSnet protocol in people with Acute Respiratory Distress Syndrome and Acute Lung Injury, run by Texas Tech University Health Sciences Center.
Trial summary
The early initiation of Airway Pressure Release Ventilation in multi-system trauma patients decreases the incidence and severity of acute lung injury and Acute Respiratory Distress Syndrome and allows faster recovery of lung function. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome, Acute Lung Injury, Respiratory Failure
- What is being tested?
- Airway Pressure Release Ventilation and ARDSnet protocol
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2008to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Trauma patients age 16 or older
- Trauma patients requiring ventilatory support within 48 hours of injury
- Those with anticipated ventilatory support ≥ 24 hours
- Subject or authorized representative (AR) has signed an informed consent form (ICF)
- Subjects age 16 or 17 who have signed an assent document and/or AR has signed an ICF
Who cannot join
- Significant chronic lung disease defined as lung pathology requiring home O2 use
- Chronic heart disease defined as NYHC III or higher
- Persistent bronchopulmonary air leak
- Contraindications to permissive hypercapnia (ex. Intracerebral bleeding, brain tumor, fulminant hepatic failure, and hemodynamic instability)
- Pulmonary artery occlusion pressures ≥ 18 mmHg
- Severe neurologic injury that may prevent the patient from having a reasonable opportunity for weaning as determined by the clinical study team
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- Immuno-compromised patients secondary to drugs or disease
- Neuromuscular disease that impairs ability to ventilate spontaneously (ex. Spinal injury at or above C5, ALS, Guillain-Barre syndrome, Myasthenia Gravis)
- History of pneumonectomy
- Pregnancy
- Burns with TBSA ≥ 20%
- Acute MI as the cause of ALI/ARDS
- All other contraindications to APRV
- Patients who cannot be randomized within 12 hours of intubation
About this study
Official title: Airway Pressure Release Ventilation as a Preventative Strategy in Patients at Risk for Acute Respiratory Distress Syndrome
The early initiation of Airway Pressure Release Ventilation in multi-system trauma patients decreases the incidence and severity of acute lung injury and Acute Respiratory Distress Syndrome and allows faster recovery of lung function.
- Being tested
- Airway Pressure Release Ventilation, ARDSnet protocol
- Keywords
- Acute Respiratory Distress Syndrome, acute lung injury, Airway Pressure Release Ventilation, ARDSnet, Bi-level, respiratory failure, trauma, APRV
- Medical subject headings
- Respiratory Distress Syndrome, Acute Lung Injury, Respiratory Insufficiency, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Airway Pressure Release VentilationDevice
Airway Pressure Release Ventilation (APRV) also known as Bi-Vent or Bi-Level ventilation is a time-cycled, pressure-limited mode of ventilation that allows spontaneous respiration throughout the ventilator cycle.
ARDSnet protocolDevice
ARDSnet protocol
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Airway Pressure Release Ventilation Arm Receives: Device: Airway Pressure Release Ventilation |
| 2 | Active comparator | ARDSnet protocol Receives: Device: ARDSnet protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint will be the number of ventilator-free days.
Measured: from randomization to study termination
Secondary outcomes (2)
effects of ventilator mode on ventilation
Measured: duration of ventilatory assistance
duration of ICU stay
Measured: time in ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionDec 2011 (estimated)
- Study completionDec 2011 (estimated)
Why it stopped: Principal Investigator left the institution before subjects were enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress SyndromeStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University Health Sciences Center
- Sponsor type
- University, hospital or other
- Investigators
- Jack Shannon, M.D., Principal investigator, Texas Tech University Health Sciences CenterJohn Griswold, M.D., Study director, Texas Tech University Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00813371
- Sponsor's protocol ID
- TTUHSC-L08-152
- Status last verified
- Aug 2009
- First submitted
- 22 Dec 2008
- Last updated
- 25 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Airway Pressure Release Ventilation as a Preventative Strategy in Patients at Risk for Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT00813371
- Acronym / sponsor ID
- TTUHSC-L08-152
- Keywords
- Acute Respiratory Distress Syndrome, acute lung injury, Airway Pressure Release Ventilation, ARDSnet, Bi-level, respiratory failure, trauma, APRV
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Principal Investigator left the institution before subjects were enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Texas Tech University Health Sciences CenterUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 23 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The early initiation of Airway Pressure Release Ventilation in multi-system trauma patients decreases the incidence and severity of acute lung injury and Acute Respiratory Distress Syndrome and allows faster recovery of lung function.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: Airway Pressure Release VentilationAirway Pressure Release Ventilation Arm |
| 2 | Active comparator | Device: ARDSnet protocolARDSnet protocol |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Trauma patients age 16 or older
- Trauma patients requiring ventilatory support within 48 hours of injury
- Those with anticipated ventilatory support ≥ 24 hours
- Subject or authorized representative (AR) has signed an informed consent form (ICF)
- Subjects age 16 or 17 who have signed an assent document and/or AR has signed an ICF
Key exclusion criteria (14 listed)
- Significant chronic lung disease defined as lung pathology requiring home O2 use
- Chronic heart disease defined as NYHC III or higher
- Persistent bronchopulmonary air leak
- Contraindications to permissive hypercapnia (ex. Intracerebral bleeding, brain tumor, fulminant hepatic failure, and hemodynamic instability)
- Pulmonary artery occlusion pressures ≥ 18 mmHg
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 |
|---|---|---|
| Airway Pressure Release VentilationAirway Pressure Release Ventilation (APRV) also known as Bi-Vent or Bi-Level ventilation is a time-cycled, pressure-limited mode of ventilation that allows spontaneous respiration throughout the ventilator cycle. | Device | 1 |
| ARDSnet protocolARDSnet protocol | Device | 2 |
Primary outcome
The primary endpoint will be the number of ventilator-free days.
Time frame: from randomization to study termination
2 secondary outcomes
effects of ventilator mode on ventilation
Time frame: duration of ventilatory assistance
duration of ICU stay
Time frame: time in ICU
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2009.
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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.
Jack Shannon, M.D. principal investigator
Texas Tech University Health Sciences Center
John Griswold, M.D. study director
Texas Tech University Health Sciences Center
Questions about this trial
What is this clinical trial studying?
A study testing Airway Pressure Release Ventilation and ARDSnet protocol in people with Acute Respiratory Distress Syndrome and Acute Lung Injury, run by Texas Tech University Health Sciences Center.
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 5 inclusion and 14 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: withdrawn, as of the sponsor's last update on 25 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
The primary endpoint will be the number of ventilator-free days. (time frame: from randomization to study termination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Aug 2009.