Airway Pressure Release Ventilation (APRV) Versus AC/VC Conventional Ventilation
1 other identifier
interventional
246
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2011
Longer than P75 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 19, 2010
CompletedFirst Posted
Study publicly available on registry
April 20, 2011
CompletedStudy Start
First participant enrolled
October 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedAugust 26, 2015
August 1, 2015
4.2 years
April 19, 2010
August 24, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
P/F Ratio on Day 3 of Mechanical Ventilation
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).
Day 3
Secondary Outcomes (2)
Amount/Duration of Sedative & Vasoactive Medication
Up to ICU discharge
Evaluate Feasibility & Clinical Compliance with 2 APRV Paper Protocols.
Up to ICU discharge
Study Arms (3)
APRV ls
EXPERIMENTALAPRV low stretch will titrate Plow to maintain release volumes between 4 and 8 cc/kg.
AC/VC Conventional Ventilation
ACTIVE COMPARATORStandard volume control ventilation with the ARDS Net protocol.
APRV h
EXPERIMENTALAPRV Habashi protocol which sets Plow equal to 0.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Hypoxemic respiratory failure requiring mechanical ventilation for \>24 hours.
You may not qualify if:
- Age under 18
- Severe chronic obstructive lung disease
- Patients in whom the only indication for mechanical ventilation is airway protection from poor neurological status.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Intermountain Medical Center
Murray, Utah, 84157, United States
LDS Hospital
Salt Lake City, Utah, 84143, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eliotte Hirshberg, MD
IHC Health Services, Inc., Dba: Intermountain Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 19, 2010
First Posted
April 20, 2011
Study Start
October 1, 2011
Primary Completion
December 1, 2015
Study Completion
June 1, 2016
Last Updated
August 26, 2015
Record last verified: 2015-08