Effect of Angulus on Patient-elevation Compliance

Summary

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.

Conditions

• Ventilator Adverse Event
• Ventilator Associated Pneumonia
• Hospital Acquired Condition
• Hospital-acquired Pneumonia
• Recumbency
• Head-of-bed

Interventions

DEVICE

Angulus

Feedback on patient recumbency

Sponsors & Collaborators

• Albert Einstein College of Medicine

  collaborator OTHER

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• Montefiore Medical Center

  collaborator OTHER

• Angulus, LLC

  lead INDUSTRY

Principal Investigators

• Michelle Gong, MD · Einstein College of Medicine, Division of Critical Care

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-07-10

Primary Completion

2018-09-30

Completion

2018-09-30

FDA Device

Yes

Countries

• United States

Study Locations