Effect of Angulus on Patient-elevation Compliance

Study Overview
=================
Brief 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.

Official Title
-----------------
Measuring the Effect of Angulus on Patient-elevation Compliance

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

Intervention / Treatment
-----------------
* Device: Angulus


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Clustered randomized cross over trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Feedback<br>The ICU with feedback will be equipped with display device corresponding to each Angulus device with an interactive software interface which displays the patient's elevation. | Device: Angulus<br>* Feedback on patient recumbency<br>|
| Other: No Feedback<br>The Angulus device will be on the patient but will NOT have the corresponding display data on patient elevation available to nurses. | Device: Angulus<br>* Feedback on patient recumbency<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance to Head of Bed Elevation to 30 Degree or More. | Measured as a continuous variable between 0% and 100% compliance. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency That Patients in the ICU Are Rotated More Than 30 Degree Within 24 Hour Days and Association With Development of Decubitus Ulcers. | As measured as categorical variable: incidence of decubitus ulcer | 3 months | 
| Frequency That Patients in the ICU Rotate More Than 30 Degree and Have Change in Elevation of More Than 15 Degree Within an Hour and Correlation With Agitation as Indicated by RASS. | As measured by continuous variable | 3 months |