Measuring the Effect of Angulus on Patient-elevation Compliance
Phase: NA
Conditions: Ventilator Adverse Event, Ventilator Associated Pneumonia, Hospital Acquired Condition, Hospital-acquired Pneumonia, Recumbency, Head-of-bed
Sponsor: Angulus, LLC

 
 
 
 
 
 
 
Effect of Angulus on Patient-elevation Compliance 
12/13/2016 

SPECIFIC AIMS 
Ventilator-associated events (VAE) are the 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%1,2, while simultaneously increasing cost of care3. Collectively, VAP 
and other VAEs result in extended hospital stays2, additional ventilator time, and reactionary treatment 
approaches. This translates into a tremendous cost burden for hospitals and compromised clinical outcomes. 
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 develop11,12,13,14. 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.  The inability to effectively, accurately and reliably measure a patient’s angle significantly 
hinders adherence to and effectiveness of HOB guidelines5,6 and the larger “VAP bundle”  – a set of evidence-
based standards published by the CDC shown to significantly reduce incidences of ventilator-associated 
pneumonia. 
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. It objectively measures a patient’s elevation, provides alerts when patients are 
out of range, and allows users to query for instant data and aggregate trends. With Angulus, critical care teams 
can effortlessly view a patient’s elevation angle at-a-glance, eliminating the need for burdensome and inexact 
HOB measurement tools.  Further, the ability to collect real time continuous patient elevation data may provide 
the necessary longitudinal data to further refine and improve patient elevation guidelines. 
We seek to empower critical care teams to increase adherence to the VAP-prevention bundle, and 
thereby improve patient outcomes in the intensive care unit. Enabling critical care treatment teams to view 
comprehensible on-demand data about a patient’s real-time elevation will empower greater compliance to the 
VAP prevention practices, and thereby reduce the incidence of VAP and other VAEs. 
To achieve our overarching goal, we will pursue the following four specific aims: 
1. Conduct initial end-user focus groups with critical care teams and stakeholders at our 
evaluation site. In order to validate existing HOB-adherence pain points and determine which critical 
hardware and software features end-users find most essential, we will conduct focus groups with the 
critical care team at our evaluation site, Montefiore Medical Center.  
2. Measure the effect of Angulus on patient-elevation (HOB) compliance. To validate the usefulness 
of Angulus in improving compliance with patient elevation, and to elucidate the usability and feasibility 
of Angulus, we will conduct a randomized crossover study implementing Angulus within two ICU’s at 
our evaluation site, Montefiore. This study will allow us to determine the effect of the Angulus 
mechanism on compliance, and quantify the percentage of time patients are spending within the 
desired recumbency with Angulus, when compared to the current standard of care. 
3. Integrate critical end-user functionality post- implementation with an agile and iterative product 
development approach and assess end-user satisfaction and usability scores.  Feedback from 
end users post implementation will enable us to enter a product refinement stage. We will measure 
satisfaction and usability outcomes, and gather feedback on user experience design and integration 
workflow hurdles. Collectively, this data will enable us to guide our next stage of product development.  
By the completion of this grant, we will have tested the Angulus prototype and made significant progress 
toward developing Angulus 2.0. Completion of these aims will enable Angulus to conduct a larger scale 
efficacy trial with Phase II funding, and will position the company to pursue commercialization efforts 
accordingly.  
 
Significance 
The goal of this application is to empower critical care teams to increase compliance with evidence-based 
patient elevation guidelines through the implementation, evaluation and refinement of Angulus – a novel dual-

component system for measuring a patient’s elevation angle in real time.  There is currently no available 
technology for critical care teams to measure patient elevation.  Present methodologies measure the 
angle of the bed, are typically primitive, and fail to have the alerting and data gathering capabilities 
required to implement true compliance.  
Ventilator-associated pneumonia (VAP) refers to pneumonia that develops at least 48 hours after the initiation 
of mechanical ventilation.1,2 VAP is considered to be a hospital-acquired infection (HAI) with incidence rates 
ranging between 10-65%1,2,18,19,20. VAP has a 30% mortality rate1,2,3,18 and results in an extended 
hospitalization – on average patients with VAP stay an additional 4.3 days in the ICU1,2,3,4. Hospitals incur an 
additional $40,000 in incremental costs per patient3, and nationally, our healthcare system is spending $10 
Billion a year on reactionary VAP treatment strategies. The data shows that VAP translates into profound cost 
expenditures and significantly compromised clinical outcomes for care settings. Adverse patient outcomes, in 
addition to national patient safety mandates, have made reducing or preventing the occurrence of VAP and 
related ventilator-associated events (VAE) a major focus of several hospital ICUs11. One such initiative 
reflecting this prioritization was the Institute for Healthcare Improvement’s (IHI) nationwide effort to reduce 
mortality and morbidity associated with hospital care by recruiting healthcare institutions to implement 
measures to prevent VAP through implementation of evidence-based practices16.  
To date, several randomized trials and observational studies have been conducted to better understand the 
causes, risk factors, interventions and treatments for VAP16,17,18,19,20. As a result of these efforts, the CDC has 
outlined best-practice evidence-based guidelines that, with effective implementation and diligent compliance, 
have been shown to reduce the incidences of VAP8. Collectively, these guidelines are referred to as the “VAP 
Bundle” and patient elevation is one component of this bundle.  Given the lack of a capability to measure 
patient elevation, Head of Bed (HOB) angle is often used interchangeably with patient elevation.  
However, these are two unique measurements – a fact that has profound implications for the 
compliance with the VAP bundle. 
Elevation of the patient is an integral part of the VAP bundle, and has been correlated with a reduction in the 
rates of VAP12,13,15. A study published in The Lancet found that placing ventilated ICU patients in a semi-
recumbent position between 30-45 degrees reduced the risk of VAP by 78%17. Yet, despite a national priority 
to reduce the incidence of VAP and related VAE, and a well-documented evidence base, which suggests that 
positioning ventilated patients at an angle between 30-45 degrees significantly reduces the potential for VAP to 
develop, many providers find it difficult to implement and comply with patient elevation guidelines6,7. A baseline 
assessment of ICU Nursing measures at Roxborough Memorial Hospital showed that compliance with patient 
elevation was low16. In fact, a study conducted at 33 academic medical ICUs found 60% of patients had at 
least one 24 hours period during which the HOB goal was never documented6. Compromised compliance with 
patient elevation does not signal an educational failure, or a lack of understanding5, but rather it is a result of 
ineffective measurement tools and nonexistent signaling mechanisms for easily, accurately and efficiently 
measuring a patient’s elevation. It is also likely that there erroneous assumption that HOB angle is equivalent 
to patient elevation results in a ‘set it and forget it’ mentality. 
Preliminary Phase I Focus Group Data  
In a preliminary focus group conducted with 20 full time ICU nurses at NY Presbyterian Hospital, 88% of 
nurses rated the bed angle of a ventilated patient as “very important” according to best practice guidelines. 
Similarly, when asked how important the bed angle of a ventilated patient is in practice, 76% of respondents 
rated it as “very important.” Zero focus group respondents rated the importance of HOB angle as “moderately 
important,” “of little importance,” or “not at all important,” suggesting that there is a deep-rooted understanding 
of the functional importance of maintaining patients at an appropriate elevation.  
Existing methodologies for measuring a patient’s elevation have failed to keep pace with the evolving needs 
and constantly increasing demands of ICU nurses6. Built in head of bed (HOB) protractors and digital 
inclinometers are the two presently available (and leading) methods for evaluating a patient’s HOB angle, 
however these devices fail to accurately measure the patient’s true elevation, and do not integrate into central 
ICU monitors or - at a minimum - have any mechanism for displaying data. Preliminary focus group data 
showed that 47% of survey respondents did not believe the HOB protractor to be correct, and many 
reported as an addendum, that HOB protractors are often broken or illegible. Without easily accessible and 
intelligible data from high-fidelity tools, ensuring compliance guidelines becomes quite challenging. 
The HOB protractor is a particularly ineffective tool due to its limited correlation with patient elevation.  This 
device, when not broken, is affixed to the joint in the hospital bed and functions like a grade school protractor. 
It measures the angle of the top half of the hospital bed relative to the bottom half of a hospital bed. Consider 

for a moment, the situation in which a patient slides down the bed or contorts their orientation to achieve 
greater comfort. As soon as the patient has introduced these or some other individual level differences in their 
orientation, the HOB protractor reading is no longer an accurate reflection of the patient angle. The HOB 
protractor measures the angle of the bed, NOT the patient. Focus group respondents bolstered this notion 
as well. Nurses reported that patients sliding down the bed, adjusting themselves, or being adjusted by loved 
ones are the three most common events which occur frequently (every 2-3 hours) and cause patients to 
become misaligned, negating the value of the HOB protractor. These frequent changes is patient 
position/posture necessitate a continuous monitoring strategy vs. a spot check approach to 
compliance.  
Current tools lack any form of a signaling mechanism, which means nurses must manually check the head of 
bed protractor every time they wish to attempt measure a patient’s elevation. Given the difficulty inherent in 
incorporating this tedious and time-intensive task into their workflow6, nurses often implement their own 
strategies for evaluating patient angle – including “eyeballing the patient’s orientation in the bed” – the primary 
strategy for checking on a patient’s elevation as reported by 30% of focus group nurses.  
Unfortunately, despite the fact that nurses fully comprehend the critical nature of patient elevation guidelines, 
many believe that they do not have a high-fidelity means for accurately determining a patient’s elevation, are 
often relying on non-functional components and piecemeal strategies, and result to hodge-podge DIY 
approaches for measuring the patient’s elevation. If one cannot easily measure a patient’s elevation, then one 
cannot ensure compliance with patient elevation guidelines. These archaic, error-prone, inefficient tools and 
approaches make the implementation of and compliance with best practice guidelines nearly impossible.  
Solution – Angulus, an eloquent system for measuring a patient’s elevation and ensuring compliance  
 ICUs would be better served by agile, accurate, 
precise and accessible tools for measuring 
and signaling patient elevation angles, in real 
time. Angulus was developed to fill this gap in 
critical care technology. Angulus is a novel 
unobtrusive system, which simplifies the process 
of measuring a patient’s elevation angle in real 
time, 
and 
facilitates 
direct 
access 
and 
interpretation of novel measurements. Angulus 
accurately measures patient elevation (vs. HOB) - irrespective of a patient’s idiosyncratic orientation – and 
transmits on-demand minute-to-minute data to a corresponding display device via low-energy Bluetooth. It also 
has the capability to collect and recall historical data and present longitudinal, aggregate trends. Angulus is 
composed of two components - a wireless sensor which is affixed to the patient’s sternum via a hypoallergenic 
adhesive, and a corresponding software interface, which displays the patient elevation angle. (Figures 2&3)  
The core of the Angulus device is a 
SensorTag 
CC2650 
(http://www.ti.com/tool/cc2650stk). 
The 
SensorTag 
incorporates 
several sensors: light, microphone, 
compass, 
magnetometer, 
hygrometer, 
pressure, 
accelerometer, 
gyroscope, 
IR 
thermometer, and ambient thermometer. The most relevant for us (and the only ones we use) are the 3D 
accelerometer and 3D gyroscope. A single chip provides “9-axis” output; the InvenSense MPU-9250 measures 
3D acceleration, 3D rotation and 3D magnetic field all in one chip.  This provides the platform for sub-degree 
accuracy.  As with any application utilizing accelerometer and gyroscope-based measurements, it is possible 
for the output values to “drift” over time, which directly affects the accuracy of the measurement. The sources 
of this drift are known (ambient temperature changes, poorly chosen sampling rate), as are several techniques 
for fixing such drift (e.g. bias-offset calibration, using ambient temperature as input, gyro-accelerometer fusion 
with a Kalman filter). Like many modern sensors the SensorTag CC2650 incorporates some drift correction.  In 
our testing, we have not observed any drift of angle readings over multi-day periods. 
The Angulus Sensor enables critical care treatment teams to instantaneously evaluate a patient’s airway angle, 
identify when the patient is outside of the desired 30-45 degree recumbency scope, and efficiently correct the 
patient’s orientation with immediate feedback. Providers receive color coded escalating visual cues when 
 
Figure 2: Illustration of Angulus Hardware Component  
 
 
Figure 3: Examples of the UX software interface that displays patient elevation data in a 
graded color coded fashion 

patients fall outside of a desired range, and can call upon user-friendly functionality such as the ability to 
snooze the device as needed. The Angulus sensor enables critical care teams to effortlessly view a patient’s 
angle at-a-glance, eliminating the need for burdensome and inexact HOB measurement tools. Via the accurate 
measurement and delivery of on-demand data about patient elevation, treatment teams will be well positioned 
to better understand patient elevation, and improve compliance to best-practice guidelines.   
By offering cutting edge functionality, Angulus is geared toward tackling the multi-faceted problems associated 
with existing ineffective methods for measuring and complying with best practice head of bed guidelines.  
In this Phase I proposal we will collaborate with Albert Einstein/Montefiore Medical center to: 1) collect end 
user feedback from focus groups and interviews 2) conduct a randomized cross over trial to measure the 
impact of Angulus on improving compliance with patient elevation guidelines, 3) quantify the relational 
discrepancy between Angulus-generated data and HOB Protractor readings, and 4) assess end-user 
satisfaction and usability measures and integrate critical high value features via an agile, iterative product 
development life cycle. Upon achieving these aims, we will have provided critical care teams with the tools that 
they need to better deliver the best care possible for ventilated patients in the ICU.  
By empowering critical care teams with intelligible, accessible and accurate on-demand data about a patient’s 
elevation angle in real time, Angulus will improve compliance with patient elevation guidelines. This work will 
have a tremendous impact on resolving a burdensome problem associated with increased patient morbidity  
and astronomical costs.  
Innovation  
Currently, there is no available technology to accurately 
measure patient elevation and thus compliance with VAP 
bundle protocols cannot be assured.  The Angulus device 
(currently in prototype form) is the first and only device that 
have been developed to accurately measure patient 
elevation angle.  It is inherently unique and discrete from 
existing present-day techniques that measuring an 
intubated patient’s HOB angle.  It incorporates the 
following novel features, which are not presently available 
with existing technologies/approaches which measure 
HOB: 1) Angulus measures patient orientation objectively 
in 3D; no other device on the market does this, 2) the 
corresponding software component incorporates signal 
processing tools to filter erroneous measurements and 
minimize the false positive alert rate, 3) the device records 
longitudinal data on patient orientation and guideline 
compliance. 
The Angulus device is an innovative application of existing 
technologies to solve an unmet medical need that has the potential to significant decrease mortality and 
medical costs in ICUs.  The device combines proprietary software interface with accelerometer, gyroscope, 
and inclinometer to create a powerful tool for ensuring patient elevation compliance.   
Our proposed solution is innovative in two key ways: 1) it greatly improves the approach and methodology by 
which providers can measure patient elevation, access those measurements and comply with best-practice 
guidelines; and 2) it represents a theoretical shift in that it measures the patient – idiosyncratic orientations and 
all - and not the bed. The dominant method for measuring patient elevation at present is the HOB protractor, 
and yet the HOB protractor presents significant complications to measuring patient elevation and improving 
compliance with patient elevation guidelines.  
Our product represents a significant breakthrough in how ventilated patient orientation is managed, and the 
Angulus system represents a tremendous advancement in how at-risk patients are evaluated and protected 
from the complications of ventilation. Perhaps, most significantly, the Angulus device’s ability to collect real 
time continuous patient elevation data may provide the necessary longitudinal data to further refine and 
improve patient elevation guidelines. 
This product meets a significant unmet need in critical care, and given the commercial potential is favorable.  
This potential could be much greater if CMS ultimately adds VAP to the list of non-reimbursable hospital 
acquired infections as it has considered doing. Completing these aims will immediately bolster our 
commercialization potential in several ways. First, robust baseline data will enable us to quantify what 
Table 1. Comparison of HOB Protractor features  
Key: ✓= feature supported ☓= Not supported ? = To Be Determined 
Feature 
HOB 
PROTRACTOR 
ANGULUS 
Non-Fixed (Flexible) Position 
☓ 
✓ 
HIPAA-compliant 
✓ 
✓ 
Accurately Measures the Patient in the 
Bed 
☓ 
✓ 
Has the ability to collect and store 
continuous data 
☓ 
✓ 
Supports aggregate trends data  
☓ 
✓ 
Transmits data wirelessly 
☓ 
✓ 
Incorporates a Software Display Screen 
on or near the ICU monitor  
☓ 
✓ 
Enables users to set a custom 
acceptable range 
☓ 
✓ 
(AIM 1) Incorporates high-value end-
user features (i.e. a snooze button) 
☓ 
✓ 
(AIM 2) Validated Patient Angle 
Accuracy  
☓ 
? 
( AIM 3) Improves Compliance with 
Patient Elevation  
☓ 
? 
AIM 4) Has Favorable Usability and 
Satisfaction Scores 
☓ 
? 

compliance looks like currently, and understand the potential for improvement. Understanding this relationship 
will allow us to understand the potential impact and effect of improving patient elevation compliance – from 
both an economical point of view, and an outcomes perspective. Second, understanding what end user 
features and functionality are considered most critical within institutions and between institutions will inform our 
product development process. Collecting satisfaction and usability scores via widely accepted and validated 
mechanisms will allow us to quantify this critical end-user feedback as well. Lastly the implementation of 
Angulus will allow our company to serve critical care settings with tools that improve their efficiency and 
compliance. This has a tremendous trickle-down impact potential for care settings. Given that the Angulus 
system is a non-significant risk device, we do not believe that the FDA regulatory pathway to commercialization 
presents tremendous hurdles or barriers.  
The Angulus technology is protected by US Patent Application No. 14/675,105, and Intl Patent Application No. 
PCT/US15/23697, which are scheduled for publication in September of 2015.  The patents being prosecuted 
cover both system and method for a number of monitoring metrics, with careful consideration of prior art. The 
IP covers the specific embodiment planned for testing as well as additional embodiments centered around 
other indications.  The patent covers measurement of patient angle with a freestanding device.  This unique IP 
is a significant strength over bed-mounted devices.  The Angulus device monitors the patient posture, not the 
bed angle.  Thus, the data collected from our device are a truer reflection of the patient’s risks arising from 
body angle position.  Angulus filed its first provisional application in March 2014 and its non-provisional and 
PCT application in March 2015.   A thorough landscape search has been conducted and Angulus has freedom 
to operate in focus indications.  One of the company's founding members, Jason Bourgeois, practices IP 
law.  Angulus is also being supported by one of the top life science-focused IP law firms in the country — 
Wilson, Sonsini, Goodrich, & Rosati.  
This project represents a unique and widely under-utilized collaboration between healthcare technology and 
academic medicine. Together, the Angulus leadership, in conjunction with our collaborative consortium 
agreement with Dr. Michelle Gong and Montefiore Medical Center, is uniquely suited to bring this product 
directly to the healthcare workers and patients who need it most.  
Approach: 
Aim 1: Conduct initial end-user focus groups with critical care teams and stakeholders at our 
evaluation site, Montefiore Medical Center.  
We intend to collect data from the clinical staff from within the Intensive Care Unit (ICU) at Montefiore Medical 
Center to elucidate attitudes, beliefs and challenges toward head of bed compliance. Understand the unique 
compliance and adherence challenges that are present for providers at Montefiore. We will begin this proposal 
by first conducting pre-implementation focus groups with the clinical staff from within the Intensive Care Unit 
(ICU) at our evaluation site, Montefiore Medical Center. Any care provider or administrator responsible for the 
care of patients in the ICU or for quality control of the hospital outcomes such as VAP will be eligible for the 
surveys and focus groups. Individual surveys and focus groups will be deployed to validate the problem with 
HOB compliance, assess treatment providers’ understanding of the VAP bundle and its importance, and 
understand existing challenges to measuring the patient’s head of bed. We have conducted similar focus 
groups at New York Presbyterian Hospital, (See preliminary Phase I focus group data above), however we will 
gather more robust data from additional end users through a rigorous quantitative and qualitative survey and 
data collection process in order to understand the landscape of unique challenges that are present at 
Montefiore.  
Additionally, for the first month of the project, we will engage our collaborators in systematic 
requirements gathering through stakeholder interviews conducted once a week for four weeks. At each 
interview the Principal Investigator and the study coordinator will interview an individual with significant 
experience in critical care. Interviews will cover a quantitative ranking of proposed features, and a qualitative 
open-ended opportunity to suggest new functionality. Utilizing this data, in conjunction with our preliminary 
focus group feedback from NYP, we will be able to identify common end-user needs and design inputs that 
exist between care settings to guide a product development strategy with the maximum potential value for 
multiple institutions. We will initially translate focus group data into a technical feature list.  The PI will then filter 
and prioritize features for incorporation into the device.  High value features will be implemented and tested in 
an alpha version of hardware and software 
Aim 2: Measure the effect of Angulus on patient-elevation (HOB) compliance 
Angulus will work collaboratively with our consortium-site PI, Dr. Michelle Gong, at our evaluation site, 
Montefiore Medical Center, to implement a cluster randomized crossover trial of Angulus in human subjects. 

The purpose of this trial is to determine how implementation of Angulus impacts compliance with patient 
elevation guidelines.  Our hypothesis is that real time feedback to nurses and bedside clinician from the 
Angulus sensor of the actual body angle of elevation of the patient rather than the angle of the bed can 
improve compliance to head elevation to 30 degrees in mechanically ventilated patients in the ICU.  In order to 
achieve this goal we will conduct a cluster randomized crossover study occurring in two (2) Intensive Care 
Units (ICU) at Montefiore Medical Center. Randomization will occur at the ICU level. 
Study Population: To participate in this study a patient must meet all of the inclusion criteria and fail to meet 
any of the exclusion criteria. 
 
The criteria for inclusion in this study are: 
• Mechanical ventilation with any modality (e.g., endotracheal tube, tracheostomy) 
• Age between 18 and 75 years 
 
The criteria for exclusion from this study are: 
• 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: 
o post-cardiac surgical patients 
o pectus excavatum (or any congenital chest wall deformity) 
o complicated skin and soft tissue infections on the chest wall 
o heart-lung machine systems 
 
Study Design: This is a two arm, clustered randomized cross over trial looking to see whether 
feedback from the Angulus device will promote greater compliance to patient elevation in the ICU.  
The overall study design is see in Figure 4.   
 
After receiving full IRB approval, all ICU nurses will receive didactic training on VAP, the 
importance of head-of-bed elevation, and a refresher on best-practice guidelines for implementing 
and ensuring compliance with the VAP bundle. These trainings will take place on two (2) separate 
occasions before each period to ensure that all ICU nurses receive the training, and will incorporate 
an evaluation component to assess comprehension.  During each period, research coordinator will 
screen each unit for newly intubated patients who fulfill the inclusion criteria but none of the exclusion 
criteria.  Eligible patients in the study ICUs at all periods will be equipped with the Angulus Device by 
tape to their sternum. Each potential participant will be given a de-identified patient code. Subjects 
will be enrolled in the trial within 36 hours of intubation, and will remain in the trial until discharge from 
the ICU.   Note that the Angulus is placed externally on the patient’s chest and secured with 
adhesives similar to what is used for EKG leads used clinically in the ICU. Angulus’ only function is to 
measure the angle of elevation of the patient in their current position.  For further discussion on the 
protection of human subjects, please see the human subjects section. The Angulus device will be 
collecting data on patient elevation “in the background.”  This will allow us to quantify the extent to 
which compliance with patient elevation is compromised under existing workflow limitations. 
During Period 1, each ICU will be randomized to Feedback of No Feedback.  The ICU with 
feedback will be equipped with display device (ipod) corresponding to each Angulus device with an 
ICU A 
ICU B 
ICU C 
Randomization  #1 
Randomization  #2 
Randomization  #3 
Period 1 
Period 2 
Period 3 
+ Feedback 
- Feedback 
+ Feedback 
+ Feedback 
+ Feedback 
+ Feedback 
- Feedback 
- Feedback 
- Feedback 

interactive software interface which displays the patient’s elevation and sends a color-coded cue 
when patients fall outside of the desired patient elevation scope. Nurses will be able to set up the 
display device and utilize all of its functionality including a snooze feature, which allows providers to 
pause the cue when patients are having a procedure, which requires they be positioned outside of the 
desired recumbent scope (i.e. a chest x-ray, etc.), or if the device must be removed (i.e. for bathing). 
Having the Angulus sensor with the corresponding display device will allow nurses to intelligibly and 
efficiently understand a patient’s elevation and make corrections as needed throughout their workday.  
Nurses can decide to use this information to reposition the patients to reach the target elevation.  In 
ICUs that are randomized to NO Feedback in Period 1, the Angulus device not have a corresponding 
display device and the data on patient elevation will NOT be displayed to the nurses. Nurses will 
continue to operate under existing clinical practices for compliance with hospital practice for elevation 
> 30 degrees, checking patient elevation according to existing methods. In Period 2, each ICU will 
cross over to the other arm and in Period 3, they will cross over back to the original arm.   Three ICU 
(Moses MICU, Moses SICU, Weiler MSICU) will be randomized as cluster with all patients who are 
mechanically ventilated in those ICU randomized as a cluster to Feedback or No Feedback.   During 
all periods of the study, whether the bedside clinician/nurse decides to adjust the patient’s body 
position or bed is left up to their clinical judgement. 
 
Statistical Analysis:   
 
The primary outcome is compliance to head of bed elevation to 30 degree or more.  This will 
be measured as a continuous variable between 0% and 100% compliance. This is defined as: 
Compliance= 100 x ((Total time in minutes in which patients in ICU are elevated > 30 degree during 
period) / (Total time patients in ICU spent with Angulus device during period)) 
From an inferential point of view, our goal is to use the data collected by the Angulus sensor to 
evaluate the effect that real-time feedback mechanism has on improving compliance with patient 
elevation guidelines. Indeed, by automating the data collection pipeline, our study will gather patient 
levels with more ease and at a finer temporal scale than was previously possible. 
Secondary outcomes of interest include: 
1. Frequency that patients in the ICU are rotated more than 30 degree within 24 hour days and 
association with development of decubitus ulcers.  As the technology in Angulus measures 
movement in 3 dimensions, it automatically records rotation in addition to elevation of patients.  
Another best care measure for mechanically ventilated patients is regular turning of patients to 
prevent formation of decubitus ulcers.  This analysis will explore whether frequency of rotation 
for a patient is associated with subsequent development of decubitus ulcers.  In this analysis, 
patients from all period and ICUs will be combined but the analysis will be stratified by period 
and ICU. 
2. 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. 
Frequent movement in patients on the ventilator can indicate agitation.  RASS is a clinically 
collected parameter indicative of levels of consciousness and agitation.   
 
Montefiore has 3 MICUs and all of the Montefiore ICU units has 12-16 beds. Based upon 
preliminary work, there are an average of 25 patients who are newly intubated each month within 
each ICU and the average duration of mechanical ventilation is 3 days. That translate to about 75 
patient-vent days per month.  Table 2 shows detectable difference given this expected sample size at 
different powers. We aim to conduct the study in 3 ICU over 3 months total.   
 
Table 2. Sample Size needed based on the minimal detectable difference for mean time in range 
between the monitored group and the non-monitored group 
 
 
70% 
75 % 
80% 
85% 

Power  
Power 
Power 
Power 
Detectable Difference 
 
 
 
 
10% difference in means 
80 
94 
100 
120 
15% difference in means 
38 
42 
48 
56 
20% Difference in means 
20 
24 
26 
30 
25% Difference in means 
14 
16 
18 
20 
 
Aim 4: Integrate critical end-user functionality post-implementation with an agile and iterative product 
development approach and assess end-user satisfaction and usability scores. 
Post implementation of the device we will utilize similar strategies deployed in Aim 1 to reassess features and 
functionality that end-users deem most high-value and critical, paying special attention to which new initially-
identified features have diminished in importance and new features that have become known. In this phase of 
end-user feedback, we will also administer the Software Usability Measurement Index (SUMI) and the System 
Usability Scale (SUS). The SUMI is an internationally validated standard used to evaluate the quality and 
satisfaction of software products. The SUS is a 10-item questionnaire used for measuring perceptions of 
usability for multi-modal systems. It has been well documented that if staff have quality tools to work with, the 
overall efficiency of staff and the quality of their work output is significantly improved. Hence, it is of prime 
importance to us to reflect upon the reported satisfaction and usability of Angulus among end-users.  
Based on the information gleaned from the successful completion of Aims 1-3, we will be well positioned to 
enter an iterative phase of rearchitecting Angulus. Completing the loop of the product development life cycle. 
We expect to use the sensor data set captured in Aim 3 to investigate the possibility of developing software 
technique to prevent false alarms cause by motions due to routine nursing care.  The system contains a Digital 
Motion Processing engine within the inertial sensor. Thus the motion sensor itself can be programmed with 
sensor-fusion algorithms to understand and respond to complex motion inputs. This will enable the system to 
recognize complex short-term patterns that correspond to routine nursing care.   
By the completion of this grant, we will have tested the Angulus prototype and made significant progress 
toward developing Angulus 2.0. Completion of these aims will enable Angulus to conduct a larger scale 
efficacy trial with Phase II funding, and will position the company to pursue commercialization efforts.  
Phase I Success Criteria.   The Phase I project will have deemed to have demonstrated feasibility if the 
Angulus device is determined to have improved the compliance with patient elevation guidelines by 15% and 
there are no adverse events associated with use of the Angulus device.  Ultimately, we expect a final post 
Phase II device to be able to improve compliance by 30% or more.  
 
 
 
 
Protection of Human Subjects 
 
Protection of Human Subjects  
a. Human Subjects Involvement, Characteristics and Design 
Angulus, as a product, has been developed specifically to improve compliance with patient elevation 
guidelines for ventilated patients in the ICU.  
Aim 1 and 3 involves focus groups and surveys/questionaires of ICU care providers and hospital 
leaders in hospital safety and quality control who are often concerned about measuring, preventing and 
reporting VAP in the hospital.  This will be conducted at Montefiore Medical Center and will involve anonymous 
participation from the respondents in which they will be queried about features and functionality of Angulus to 
help guide refinement of the product. No personal information or identifiers of the participants will be collected.  
We plan on a verbal consent from participants. 
Aim 2 outlines a cluster cross over randomized clinical trial designed to evaluate the usefulness and 
feasibility of Angulus in a critical care setting.  We will enroll ventilated patients from 3 ICUs in this trial. We 
anticipate that study participants will be older than 18, have an equal male to female ratio, and have poor 
health status. Randomization will occur at the unit-level, not the individual level, and each unit will serve as its 

own control as with our current study design the assignments switch after each period.   We will apply for a 
waiver of informed consent for data collection as this study fulfills all criteria for waiver of informed consent: 
Subjects will be enrolled in the trial within 36 hours of intubation, and will remain in the trial until ICU 
discharge.  
Participation is not limited by patients’ race, sex, ethnicity or socioeconomic class, and no potential 
subjects will be excluded based on these criterion. We are not incorporating fetuses, neonates, pregnant 
women, children, prisoners or institutionalized individuals, although ventilated patients are considered to be a 
vulnerable population.  
This is a minimal risk study.  Head of bed elevation is already standard of care for ventilated patients in the 
ICU.  However, the current practice is by “eyeballing” the patient or measuring the angle of the bed rather than 
the patient.  Aim 3 sets out to measure the actual angle of elevation of the patient and in the active phase, 
provide this information to the nurses to see if it can help them improve their compliance to elevation of 
patient’s head to prevent VAP.   Angulus is a non-invasive, non-significant risk device, there are not any 
components, which present hazardous procedures, situations or materials to personnel and/or study subjects. 
Moreover, intubated patients already have a number of monitors and sensors affixed on or near them during 
their inpatient hospitalization.  An additional sensor will cause additional complications and no other monitors 
or sensor will be removed in order to allow Angulus to be used.  
 
b. Sources of Materials 
In Aim 1 and 3, the sources of material will be the responses from the voluntary interviews, surveys and focus 
group. In Aim #2, the research material obtained from human subjects will be the data sent from the Angulus 
sensor and stored on the iPod touch display device. This data is stored locally and does not require the input 
or transmission of any PHI. The iPod touch display device is securely attached below the vital sign monitor, 
and each disposable sensor is assigned to a specific patient and display device. Acquired data are stored in an 
internal database, which cannot be accessed outside the application, and advanced features such as data 
export are password-protected. Data export must be performed via physical connection (i.e. via USB), onto an 
encrypted laptop.  Additional patient level data on age, gender, BMI, and race will be collected from medical 
records.  No identifying information will be collected. 
 
c. Potential Risks 
This is ultimately a study of compliance, and even though subjects will be assigned to active or control 
conditions, they will still receive the same standard of care that they are receiving now, with the potential for it 
to improve. Given that this is a non-significant, non-invasive mechanism, we do not anticipate there to be any 
psychological, financial, legal risks for subjects who are enrolled in the trial. The only risk we have identified is 
the potential for an allergic reaction to the adhesive. To protect against this risk, we will not enroll patients with 
a known allergy to our adhesive.  
 
 
Protection Against Risks 
 
a. Informed Consent  
For Aim 1 and 3 on the focus groups and surveys on useabiity of Angulus, we will apply for a verbal consent 
from end-users for participation.  For the purpose of Aim 2, we intend to submit a request for a waiver of 
informed consent, as the outcomes of this trial focus exclusively on quality improvement metrics, rather than 
clinical efficacy outcomes.  As per 45 CFR 46.116d, Aim 3 would meet the required 4 criteria for a waiver of 
informed consent: 
1. The research involves no more than minimal risk to the subjects:  Angulus is a non-invasive, non-
significant risk device that aims to provide real time data to nurses and other providers on compliance 
to elevation of the head of ventilated patients to prevent VAP.  Decision about whether to change the 
patient’s position or bed angle is still left to the bedside clinician. 
2. The waiver will not adversely affect the rights and welfare of the subjects: Head of bed elevation does 
not require patient consent in current clinical care.  Indeed, this is considered standard of care for all 
ventilated patients in the ICU. 
3. The research could not be practically carried out without a waiver: Aim 2 proposes a cluster 
randomization of an ICU. It is neither practical nor possible to consent every ventilated patient in the 
ICU in a timely fashion as head of bed elevation is supposed to be implemented as soon as possible 

after intubation and is part of the ventilator bundle orders for initiation of mechanical ventilation for 
patients at Montefiore.  
4. When appropriate, the subject will be provided with additional pertinent information after participation. 
We do not anticipate any information from this trial will be pertinent to the patient’s health or clinical 
outcome as elevation of head is already standard of care for patients in the ICU. 
b. Protections Against Risks 
To minimize the possibility of a data breach, all data will be de-identified and stored in encrypted 
databases to prevent the possibility for any potential breach of PHI. No names or HIPAA identifiers will be 
associated with computerized data files and similarly any published materials will represent de-identified 
aggregate data. Data collected from the sensors will be stored locally on the display device prior to being 
downloaded. Data will be downloaded to a secure encrypted laptop upon patient discharge.  
In order to ensure strict adherence to HIPAA compliance, no data will be sent over wireless networks, 
and all downloaded data will be stripped of any potential patient identifiers.  
In order to adhere to infection control and patient safety standards, over the course of both phases of 
the study, the Angulus hardware component will be enclosed in a disposable encasing with disposable 
adhesive. Additionally, the display devices will be encompassed in a disposable protective case to prevent the 
carry over of any infectious organisms during patient turnover. The only re-usable component of this 
mechanism is the sensor itself (which is then enclosed in a disposable encasing). 
To minimize the potential for any physical adverse reactions, we will exclude any patients with a known 
allergy to our adhesive.  
 
Potential Benefits  
 
Under our current study design and hypothesis, we are proposing that implementation of the Angulus sensor 
with corresponding data display will improve compliance with patient HOB guidelines. This could be a potential 
benefit of the research to participants. Since adherence to patient elevation guidelines are currently low, and 
patient elevation has been shown to have a significant impact on the development of VAP, increasing 
compliance in this domain could greatly improve the quality of care ventilated patients are receiving. 
 
Data and Safety Monitoring Plan 
 
While we do not intend to establish a formal Data Safety Monitoring Board (DSMB), we will abide by local and 
regulatory requirements for reporting adverse events (AEs) to local and federal regulatory agencies in a timely 
manner. Any adverse events identified by the study team or providers will be reported to the study coordinator 
and both PIs, and appropriately recorded and sent to the necessary regulatory entity for review.