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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Intermountain Health Care, Inc.
Sponsor:
Information provided by (Responsible Party):
Eliotte L. Hirshberg, Intermountain Health Care, Inc.
ClinicalTrials.gov Identifier:
NCT01339533
First received: April 19, 2010
Last updated: September 5, 2013
Last verified: September 2013
  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
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: 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 Intermountain Health Care, Inc.:

Primary Outcome Measures:
  • P/F Ratio on Day 3 of Mechanical Ventilation [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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: June 2014 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Eliotte L. Hirshberg, Principal Investigator, Intermountain Health Care, Inc.
ClinicalTrials.gov Identifier: NCT01339533     History of Changes
Other Study ID Numbers: APRV1015758
Study First Received: April 19, 2010
Last Updated: September 5, 2013
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on July 20, 2014