CClinicalTrials.gg
WithdrawnNCT00813371Updated Aug 25, 2009

Airway Pressure Release Ventilation as a Preventative Strategy

An interventional study of Airway Pressure Release Ventilation and ARDSnet protocol in Acute Respiratory Distress Syndrome, Acute Lung Injury and Respiratory Failure, sponsored by Texas Tech University Health Sciences Center. Withdrawn. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2009-08-25.

Sponsored by Texas Tech University Health Sciences Center · Not applicable, Interventional, and Prevention

Why this study was withdrawn
Principal Investigator left the institution before subjects were enrolled
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
16 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • 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
03

In context

Respiratory Distress Syndrome

1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.

Browse Respiratory Distress Syndrome studies →

Lead sponsor

Texas Tech University Health Sciences Center is the lead sponsor of 97 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Active comparator
    1

    Airway Pressure Release Ventilation Arm

    Device: Airway Pressure Release Ventilation

  • Active comparator
    2

    ARDSnet protocol

    Device: ARDSnet protocol

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

06

What researchers measure

Primary outcomes

  1. The primary endpoint will be the number of ventilator-free days.

    Time frame: from randomization to study termination

Secondary outcomes

  1. effects of ventilator mode on ventilation

    Time frame: duration of ventilatory assistance

  2. duration of ICU stay

    Time frame: time in ICU

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 25, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00813371
Lead sponsor
Texas Tech University Health Sciences Center
First posted
Dec 23, 2008
Start date
Dec 2008
Primary completion
Dec 2011 (estimated)
Completion
Dec 2011 (estimated)
Last update
Aug 25, 2009

Study contacts

Jack Shannon, M.D.
principal investigator · Texas Tech University Health Sciences Center
John Griswold, M.D.
study director · Texas Tech University Health Sciences Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is withdrawn, as verified in Aug 2009. You cannot join it, but the record below documents what was studied.

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