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Airway Pressure Release Ventilation (APRV) Versus AC/VC Conventional Ventilation

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2015 by Eliotte L. Hirshberg, Intermountain Health Care, Inc..
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01339533
First Posted: April 20, 2011
Last Update Posted: August 26, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Eliotte L. Hirshberg, Intermountain Health Care, Inc.
  Purpose
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.

Condition Intervention Phase
Respiratory Failure Acute Lung Injury (ALI) Acute Respiratory Distress Syndrome (ARDS) Device: Mechanical Ventilation Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Airway Pressure Release Ventilation (APRV) vs. Conventional Volume Control Mechanical Ventilation for Patients With Respiratory Failure Requiring Invasive Mechanical Ventilator Support

Resource links provided by NLM:


Further study details as provided by Eliotte L. Hirshberg, Intermountain Health Care, Inc.:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Amount/Duration of Sedative & Vasoactive Medication [ Time Frame: Up to ICU discharge ]
    Our second objective is to compare the amount and duration of sedative medication and vasoactive medication per patient per/day required in each group. Duration of vasoactive medications and sedation (# of days) and quantitative amounts per kilogram will be compared. Measurements will include Mean Arterial Blood Pressure (MAP), Central venous pressure (CVP), and daily fluid balance between patients on AC and APRV.

  • Evaluate Feasibility & Clinical Compliance with 2 APRV Paper Protocols. [ Time Frame: Up to ICU discharge ]
    Our third objective is to evaluate the feasibility of 2 previously developed APRV paper protocols (APRVa and APRVb) and document the clinician compliance with each paper APRV protocol. We will also track common events associated with mechanical ventilation. The incidence of pneumothorax defined as any ventilator-barotrauma resulting in chest tube placement, will be carefully followed.


Estimated Enrollment: 246
Study Start Date: October 2011
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: APRV ls
APRV low stretch will titrate Plow to maintain release volumes between 4 and 8 cc/kg.
Device: Mechanical Ventilation
Patients who experience problems breathing and require assistance in breathing are placed on a machine that delivers air to the lungs through a tube through the vocal cords. This study is testing 3 protocols for that machine.
Active Comparator: AC/VC Conventional Ventilation
Standard volume control ventilation with the ARDS Net protocol.
Device: Mechanical Ventilation
Patients who experience problems breathing and require assistance in breathing are placed on a machine that delivers air to the lungs through a tube through the vocal cords. This study is testing 3 protocols for that machine.
Experimental: APRV h
APRV Habashi protocol which sets Plow equal to 0.
Device: Mechanical Ventilation
Patients who experience problems breathing and require assistance in breathing are placed on a machine that delivers air to the lungs through a tube through the vocal cords. This study is testing 3 protocols for that machine.

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01339533


Contacts
Contact: Eliotte Hirshberg, MD 801-232-9120 ellie.hirshberg@imail.org

Locations
United States, Utah
Intermountain Medical Center Recruiting
Murray, Utah, United States, 84157
Principal Investigator: Eliotte Hirshberg, MD         
LDS Hospital Recruiting
Salt Lake City, Utah, United States, 84143
Sub-Investigator: Terry Clemmer, MD         
Sponsors and Collaborators
Intermountain Health Care, Inc.
Investigators
Principal Investigator: Eliotte Hirshberg, MD IHC Health Services, Inc., Dba: Intermountain Medical Center
  More Information

Responsible Party: Eliotte L. Hirshberg, Principal Investigator, Intermountain Health Care, Inc.
ClinicalTrials.gov Identifier: NCT01339533     History of Changes
Other Study ID Numbers: APRV1015758
First Submitted: April 19, 2010
First Posted: April 20, 2011
Last Update Posted: August 26, 2015
Last Verified: August 2015

Keywords provided by Eliotte L. Hirshberg, Intermountain Health Care, Inc.:
ALI
ARDS

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Respiratory Insufficiency
Acute Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Thoracic Injuries
Wounds and Injuries