Airway Pressure Release Ventilation as a Preventative Strategy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2011-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Acute Respiratory Distress Syndrome Acute Lung Injury Respiratory Failure Trauma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

Airway Pressure Release Ventilation Arm

Group Type ACTIVE_COMPARATOR

Airway Pressure Release Ventilation

Intervention Type DEVICE

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.

2

ARDSnet protocol

Group Type ACTIVE_COMPARATOR

ARDSnet protocol

Intervention Type DEVICE

ARDSnet protocol

Interventions

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Airway Pressure Release Ventilation

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.

Intervention Type DEVICE

ARDSnet protocol

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No