Status:

WITHDRAWN

Airway Pressure Release Ventilation (APRV) Compared to ARDSnet Ventilation

Lead Sponsor:

University of Tennessee, Chattanooga

Conditions:

Acute Lung Injury

Adult Respiratory Distress Syndrome

Eligibility:

All Genders

18-85 years

Phase:

PHASE2

Brief Summary

Traditional modes of ventilation have failed to improve patient survival. Subsequent observations that elevated airway pressures observed in traditional forms of ventilation resulted in barotrauma and...

Detailed Description

Low volume ventilation may increase number of ventilatory free days and may improve overall patient survival. While reducing mean airway pressure has reduced barotrauma and improved patient survival, ...

Eligibility Criteria

Inclusion

  • All patients admitted to the Internal Medicine service at the Baroness Erlanger Hospital of the University of Tennessee College of Medicine with hypoxia (O2 saturation \< 93%) and pulmonary distress, will be screened for study participation.
  • Patients displaying all the following clinical criteria: acute onset of respiratory failure; hypoxia defined as a PaO2/FiO2 ratio of \< 300 Torr; pulmonary capillary wedge pressure less or equal than 18 mm Hg, and/or no clinical evidence of left sided heart failure; and chest x-ray with diffuse bilateral pulmonary infiltrates.

Exclusion

  • Patients receiving conventional volume ventilation with or without PEEP for \> 6 hours prior to study enrollment
  • Patient's family or surrogate unwilling to give informed consent
  • Patients requiring sedation or paralysis for effective ventilation
  • Patients known pulmonary embolus within 72 hours of study enrollment
  • Patients with close head injuries or evidence of increased intracranial pressure
  • Patients with burns over 30% of total body surface area
  • Pulmonary capillary wedge pressure greater than 18 mm Hg
  • CVP \> 15 cm H2O
  • Patients with B type Naturetic peptide levels \> 1000
  • Patients with prior history of dilated cardiomyopathy with EF \< 25%
  • Patients receiving chronic outpatient peritoneal or hemodialysis
  • Patients with severe liver disease (as defined by Child-Pugh class C)
  • AIDS patients

Key Trial Info

Start Date :

November 2 2020

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

November 2 2020

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT00793013

Start Date

November 2 2020

End Date

November 2 2020

Last Update

November 4 2020

Active Locations (1)

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Page 1 of 1 (1 locations)

1

James A. Tumlin, MD

Chattanooga, Tennessee, United States, 37403