Airway Pressure Release Ventilation as a Preventative Strategy (NCT00813371) | Clinical Trial Compass
WithdrawnNot Applicable
Airway Pressure Release Ventilation as a Preventative Strategy
Stopped: Principal Investigator left the institution before subjects were enrolled
0Started 2008-12
Plain-language 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.
Who can participate
Age range
16 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The primary endpoint will be the number of ventilator-free days.
Timeframe: from randomization to study termination
Trial details
NCT IDNCT00813371
SponsorTexas Tech University Health Sciences Center