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Clinical Trials/NCT01339533
NCT01339533
Unknown
Phase 2

Airway Pressure Release Ventilation (APRV) vs. Conventional Volume Control Mechanical Ventilation for Patients With Respiratory Failure Requiring Invasive Mechanical Ventilator Support

Intermountain Health Care, Inc.2 sites in 1 country246 target enrollmentOctober 2011

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Respiratory Failure
Sponsor
Intermountain Health Care, Inc.
Enrollment
246
Locations
2
Primary Endpoint
P/F Ratio on Day 3 of Mechanical Ventilation
Last Updated
10 years ago

Overview

Brief Summary

APRV mode of ventilation will result in an improved partial pressure of arterial oxygenation/ fraction of inspired oxygen (P/F ratio) on day 3 of mechanical ventilation. Sub hypotheses: APRV will be associated with a reduced amount of sedation used during the ICU stay in patients with respiratory failure. APRV will be associated with a reduction in the amount of vasoactive medication used for blood pressure support in patients with respiratory failure.

Detailed Description

This prospective un-blinded randomized trial will follow patients with respiratory failure and ALI/ARDS who require invasive mechanical ventilation in select ICUs. Patients will be allocated to respiratory support with either APRV mode or volume control (AC) mode of mechanical ventilation. Qualifying patients will be randomized by permuted block randomization within 24 hours of admission to the ICU. Identical ventilation and oxygenation thresholds will be utilized to guide titration of each ventilator protocol. Patients will remain on the assigned mode of ventilation until they are extubated and discharged from the ICU. Procedures for treatment evaluation include daily monitoring of the Ventilator protocol in each arm. Clinical coordinator and study respiratory therapist will perform 2 daily checks of the study patients to determine compliance with the protocol and if patient meets weaning criteria. The previously published ARDS Network continuous positive airway pressure (CPAP) weaning protocol will be used for all patients enrolled.

Registry
clinicaltrials.gov
Start Date
October 2011
End Date
June 2016
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Eliotte L. Hirshberg

Principal Investigator

Intermountain Health Care, Inc.

Eligibility Criteria

Inclusion Criteria

  • Hypoxemic respiratory failure requiring mechanical ventilation for \>24 hours.

Exclusion Criteria

  • Age under 18
  • Severe chronic obstructive lung disease
  • Patients in whom the only indication for mechanical ventilation is airway protection from poor neurological status.

Outcomes

Primary Outcomes

P/F Ratio on Day 3 of Mechanical Ventilation

Time Frame: Day 3

Our first objective is to measure and compare the partial pressure of oxygen in the artery to the inspired oxygen ratio (P/F ratio) on day 3 of mechanical ventilation. We will also collect and compare common variables used to evaluate lung injury and severity of respiratory failure in both groups. These variables and markers include: the Oxygenation index (OI) and standard blood gas parameters (PH, PaCO2 and PaO2).

Secondary Outcomes

  • Amount/Duration of Sedative & Vasoactive Medication(Up to ICU discharge)
  • Evaluate Feasibility & Clinical Compliance with 2 APRV Paper Protocols.(Up to ICU discharge)

Study Sites (2)

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