Airway Pressure Release Ventilation as a Preventative Strategy

Airway Pressure Release Ventilation as a Preventative Strategy in Patients at Risk for Acute Respiratory Distress Syndrome

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00813371

Enrollment

Registered

2008-12-23

Start date

2008-12-31

Completion date

2011-12-31

Last updated

2009-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Distress Syndrome, Acute Lung Injury, Respiratory Failure, Trauma

Keywords

Acute Respiratory Distress Syndrome, acute lung injury, Airway Pressure Release Ventilation, ARDSnet, Bi-level, respiratory failure, trauma, APRV

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.

Interventions

DEVICEAirway 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.

DEVICEARDSnet protocol

ARDSnet protocol

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
effects of ventilator mode on ventilation	duration of ventilatory assistance
duration of ICU stay	time in ICU

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026