MARCH 27 TH , 2018 STAGE-GATING 6 TAYLOR COMBS, MEGAN HOLMBERG, - - PowerPoint PPT Presentation

MARCH 27TH , 2018 – STAGE-GATING 6 TAYLOR COMBS, MEGAN HOLMBERG, SEIVER JORGENSEN, & SAM KULTGEN

Problem Statement

Free-field audibly medical alarms are loud and

• uninformative. The alarms

cause sleep deprivation for patients and alarm fatigue for clinicians.

Patient Needs Assessment

• Must not infringe on patient confidence in provider
• Safety for Patient
• Must have informative alarms to improve positive predictive value
• Must not interfere with conversation and normal sounds
• Must include alert for low battery and system malfunction

Provider Needs Assessment

• Interface
• Should have volume control
• Should have haptic feedback control
• Should have button to acknowledge receipt of

alarm

• Safety for Wearer
• Must be insulated to prevent shock and excessive

heating

• Must be sweatproof, waterproof
• Provider Efficacy
• Should be available in multiple sizes
• Must be comfortable to wear all day
• Must stay in ear easily
• Transmitted alarms must not overbearing
• Should have a haptic component to alarm signal
• Must be sterilizable
• Must have long battery life
• Should not receive unnecessary alarms to prevent

alarm fatigue

• Must be wireless with stable connection to

central hub

System Needs Assessment

• Cost Efficacy
• Must be able to be purchased in bulk by hospitals or clinics
• Should have long shelf life and capability to be activated as

needed

• Less than $500 per unit
• Central Control
• Must be able to selectively add patients to individual device
• Must be able to direct signal to alert physician and/or nurse by

need

• Must improve positive predictability of medical alarms.

STUDY

PROTOCOL

PHYSIOLOGICAL SOUNDSCAPES

• Comprised of 4 variables
• Heart Rate (Drums)
• Blood Pressure (Piano)
• Blood Oxygenation (Guitar)
• Haptic Stimulus

Image adapted from Koen Bogers @ TU Delft

SOUND COMPONENTS

The physiological soundscapes components change in timbre as the sonified variables move away from the desired set-point range.

PHYSIOLOGICAL STAIRCASE

Baseline

• 1
• 2
• 3

+1 +2 +3

BUILDING PHYSIOLOGICAL SOUNDSCAPES

• Built Individual Sound Conditions
• Each collects the 4 variables of the

soundscape for a given condition

• Ex. HR+3, BP-3, SpO2 90, Haptuator -3
• Complied Into Physiological Soundscapes
• This develops changes over time for each 12

minutes block within the study

SSRT AND NEW GRAPHIC USER INTERFACE

NEW GRAPHIC USER INTERFACE

Version 1: Issues

• No submit button
• Parameter must be selected before Direction
• Selections not visible
• Initial choices cannot be changed
• No allowance for accidental user clicks

Version 2: Solutions

• Added submit button
• GUI will not close until clicked
• Radio buttons instead of push buttons
• Selection is visible and can be changed
• Only one selection possible for each

category—more foolproof

AfterShokz TREKZ Titanium Bone Conductor Headphones Lofelt Basslet Haptuator

BME IDEAS GRANT

• Description of Problem to be Solved
• ICU delirium in up to 80% of patients
• Delirium-induced cognitive impairments can last months to years after ICU stay
• Final Prototype
• Added images to section
• Need: further detail about purpose of each component
• Estimated Manufacturing Costs
• $267 in hardware
• ~$300 / device
• Regulatory Pathway
• Sounds: Class II (510k)
• Device: Class I

BIBLIOGRAPHY

lirezaee, Parisa, et al. “Did You Feel That? Developing Novel Multimodal Alarms for High Consequence Clinical Environments.” Proceedings of the 23rd International Conference on Auditory Display ICAD 2017, 2017, doi:10.21785/icad2017.066. Edworthy, J. “Alarms and Human Behaviour: Implications for Medical Alarms.” British Journal of Anaesthesia, vol. 97, no. 1, 2006, pp. 12–17., doi:10.1093/bja/ael114. Edworthy, J. “Fewer but Better Auditory Alarms Will Improve Patient Safety.” Quality and Safety in Health Care, vol. 14, no. 3, Jan. 2005, pp. 212–215., doi:10.1136/qshc.2004.013052. Edworthy, J. “Medical Audible Alarms: a Review.” Journal of the American Medical Informatics Association, vol. 20, no. 3, Jan. 2013, pp. 584–589., doi:10.1136/amiajnl-2012-001061. Edworthy, Judy Reed, et al. “Classifying Alarms: Seeking Durability, Credibility, Consistency, and Simplicity.” Biomedical Instrumentation & Technology, vol. 51, no. s2, 2017, pp. 50–57., doi:10.2345/0899-8205-51.s2.50. Edworthy, Judy, et al. “Improving Auditory Warning Design: Relationship between Warning Sound Parameters and Perceived Urgency.” Human Factors: The Journal of the Human Factors and Ergonomics Society, vol. 33, no. 2, 1991, pp. 205–231., doi:10.1177/001872089103300206 Hasanain, Bassam, et al. “A Formal Approach to Discovering Simultaneous Additive Masking between Auditory Medical Alarms.” Applied Ergonomics, vol. 58, 2017, pp. 500–514., doi:10.1016/j.apergo.2016.07.008. Knox, Richard. “Silencing Many Hospital Alarms Leads To Better Health Care.” NPR, National Public Radio, 27 Jan. 2014, www.npr.org/sections/health-shots/2014/01/24/265702152/silencing- many-hospital-alarms-leads-to-better-health-care. Ruskin, Keith J., and Dirk Hueske-Kraus. "Alarm fatigue: impacts on patient safety." Current Opinion in Anesthesiology 28.6 (2015): 685-690. Schlesinger, Joseph J., et al. “Frequency-Selective Silencing Device for Digital Filtering of Audible Medical Alarm Sounds to Enhance ICU Patient Recovery.” Proceedings of the 23rd International Conference on Auditory Display - ICAD 2017, 2017, doi:10.21785/icad2017.062. White, Jess. “New for 2016: Joint Commission Updates Alarm Guidelines.” Healthcare News & Insights, Joint Commission, 30 Dec. 2015, www.healthcarebusinesstech.com/alarms-2016/.