Airway Pressure Release Ventilation as a Preventative Strategy

NCT00813371 | Withdrawn

• 1 other identifier: TTUHSC-L08-152
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (1)

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

  from randomization to study termination

Secondary Outcomes (2)

• effects of ventilator mode on ventilation

  duration of ventilatory assistance

• duration of ICU stay

  time in ICU

Study Arms (2)

1

ACTIVE COMPARATOR

Airway Pressure Release Ventilation Arm

Device: Airway Pressure Release Ventilation

2

ACTIVE COMPARATOR

ARDSnet protocol

Device: ARDSnet protocol

Interventions

Airway Pressure Release Ventilation 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.

1

ARDSnet protocol DEVICE

ARDSnet protocol

2

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Texas Tech University Health Sciences Center: lead

MeSH Terms

Conditions

Respiratory Distress Syndrome; Acute Lung Injury; Respiratory Insufficiency; Wounds and Injuries

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Lung Injury

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Jack Shannon, M.D.

  Texas Tech University Health Sciences Center

  PRINCIPAL INVESTIGATOR

• John Griswold, M.D.

  Texas Tech University Health Sciences Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 22, 2008
• First Posted: December 23, 2008
• Study Start: December 1, 2008
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: August 25, 2009

Record last verified: 2009-08