Airway Pressure Release Ventilation as a Preventative Strategy

Acute Respiratory Distress Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00813371
• Other study ID #: TTUHSC-L08-152
• Status: Withdrawn
• Phase: N/A
• First received: December 22, 2008
• Last updated: August 24, 2009
• Start date: December 2008
• Est. completion date: December 2011

Study information

• Verified date: August 2009
• Source: Texas Tech University Health Sciences Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Lung Injury
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Respiratory Failure
• Respiratory Insufficiency
• Trauma

Intervention

Device:
• 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.
• ARDSnet protocol
ARDSnet protocol

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Texas Tech University Health Sciences Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint will be the number of ventilator-free days.		from randomization to study termination	No
Secondary	effects of ventilator mode on ventilation		duration of ventilatory assistance	No
Secondary	duration of ICU stay		time in ICU	No