Airway Pressure Release Ventilation as a Preventative Strategy

Not Applicable

Withdrawn

• Conditions: Acute Respiratory Distress Syndrome; Acute Lung Injury; Respiratory Failure; Trauma
• Interventions: Device: Airway Pressure Release Ventilation; Device: ARDSnet protocol

• Registration Number: NCT00813371
• Lead Sponsor: Texas Tech University Health Sciences Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2008-12-22
• Study First Submitted QC: 2008-12-22
• Study First Posted: 2008-12-23
• Status Verified: 2009-08
• Last Update Submitted: 2009-08-24
• Last Update Posted: 2009-08-25
• Primary Completion: 2011-12
• Study Completion: 2011-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Airway Pressure Release Ventilation	Airway Pressure Release Ventilation Arm
2	ARDSnet protocol	ARDSnet protocol

Primary Outcome Measures

Name	Time	Method
The primary endpoint will be the number of ventilator-free days.	from randomization to study termination

Secondary Outcome Measures

Name	Time	Method
effects of ventilator mode on ventilation	duration of ventilatory assistance
duration of ICU stay	time in ICU