Effect of Angulus on Patient-elevation Compliance

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Description

Ventilator-associated events (VAE) are a scourge of critical care settings and hospital systems at large. There is extensive evidence that ventilator-associated pneumonia (VAP) and related VAEs increase mortality rates in critically ill patients by up to 50%, while simultaneously increasing cost of care. C Best-practice guidelines state that positioning ventilated patients at an angle between 30-45 degrees significantly reduces the potential for VAP and other VAE to develop. While the intent of the guidelines is to govern patient elevation angle, the lack of a mechanism to accurately measure patient elevation requires that nurses rely on the head-of-bed (HOB) protractor - a tool which reflects the angle of the bed, not the patient - to measure compliance. Depending upon the position and posture of the patient in the bed, a patient's elevation angle may be significantly different from the HOB angle. Critical care teams currently rely on built-in HOB protractors and digital inclinometers that measure the angle of the bed not the patient. Angulus, LLC has developed a dual-component Angulus sensor to fill this gap in critical care technology. Angulus enables critical care practitioners to instantaneously understand a patient's elevation, identify when the patient is outside of the desired 30-45 degree recumbency scope, and efficiently correct the patient's orientation with immediate feedback. Angulus supports real-time minute-to-minute data display as well as longitudinal aggregation of data.

Study Start Date

June, 01 2018

Estimated Completion Date

April 2019

Interventions

Device: Angulus

Study ID

Angulus, LLC -- 001

Status

Recruiting

Trial ID

NCT03496220

Study Type

Interventional

Trial Phase

N/A

Enrollment Quota

200

Sponsor

Angulus, LLC

Inclusion Criteria

Mechanical ventilation with any modality (e.g., endotracheal tube, tracheostomy)
Age between 18 and 75 years

Exclusion Criteria

Patients with a known allergy to the encasing materials
Patients who are advised to be positioned outside of the 30-45 degree scope.
Patients with any major chest wall abnormalities, or defects, including but not limited to:
post-cardiac surgical patients
pectus excavatum (or any congenital chest wall deformity)
complicated skin and soft tissue infections on the chest wall
heart-lung machine systems

Gender

All

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Study Locations and Contact Information (1)

Study Location	Distance	Name	Phone	Email
Montefiore Medical Center - Bronx, New York	40.3 miles	Clinical Research Coordinator	None	dafuster@montefiore.org

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