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 range16 Years
SexALL
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
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