Neonatology/Biomedical Optics Research Laboratory
Health Monitoring Prof. Martin Wolf Biomedical Optics Research Laboratory Clinical Research Priority Program Tumor Oxygenation Department of Neonatology University Hospital Zurich
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Neonatology/Biomedical Optics Research Laboratory
What does the patient need? • Human beings consist of mind, soul and body • Mind/spirit: Thinking, speaking, reasoning (e.g. science): → Autonomy, responsibility, decision making, planning • Soul: Feeling, like, dislike: → Well-being, freedom of adverse feelings (pain), safety, privacy • Body: Visible, physical part: → Integrity, ability to move, support and therapy in case of physiological disorder
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Neonatology/Biomedical Optics Research Laboratory
What does the physician need? • Cares mostly about the body and needs: → Diagnostic information • Reliable • Accurate • Timely • Relevant • Treatment decision • Implement therapy: • EBM is the integration of clinical expertise, patients preference, and the best available evidence into the decision making process for patient care. (DL Sackett et al. BMC 1996; 312:71-2)
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What do the regulatory bodies need? • Documents to prove that everything is legal: → Compliance with norms (e.g. ISO) → Risk analysis → CE mark or notification to Swissmedic → Research: Approval of ethical committee
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Neonatology/Biomedical Optics Research Laboratory
What does the engineer/scientist need? • Motivation to help the patient • Clinically relevant aim • Knowledge in physiology • An idea how to address the aim • Specifications for the device • Thorough risk analysis • Ability to implement the device • Strong perseverance to complete all the paperwork (legalese) • Close contact to medical staff (interdisciplinary collaboration)
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Neonatology/Biomedical Optics Research Laboratory
Need in the future for health monitoring • Patient will be older • Increased morbidity • Higher need for monitoring devices
Noninvasive Cost effective, affordable
Reliable
• The need to ensure autonomy and safety Sustainable
Monitoring device
Unobtrusive
Appropriate
Continuous
Safe
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Neonatology/Biomedical Optics Research Laboratory
Application examples (ParaTex, TecInTex) Aim: Prevention of pressure ulcers in paraplegics
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Neonatology/Biomedical Optics Research Laboratory
Obesense Aim: Monitoring of energy expenditure to limit the consequences of obesity.
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Neonatology/Biomedical Optics Research Laboratory
SmartSphincter Aim: Restore anal sphincter function and continence
WiseSkin Aim: Restore the sensation of touch
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Title of the presentation, Author
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Neonatology/Biomedical Optics Research Laboratory
NewbornCare Aim: Novel contactless system to improve reliability of vital signs monitoring in neonatal intensive care. %
100
16
90
14
80
SaO 2
PO2
12
70 60
10
50
8
40
6
30
4
20
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11:00:00
10:59:00
10:58:00
10:57:00
10:56:00
10:55:00
10:54:00
10:53:00
0 10:52:00
0 10:51:00
2 10:50:00
10
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kPa
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Neonatology/Biomedical Optics Research Laboratory
NewbornCare Problem: Many false alarms (85%). Lead to “crying wolf syndrome� and stress %
16 kPa
100 90
14
80
12
70 SaO 2
60
10
PO2
50
8
40
6
30
4
20
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20:32:00
20:31:00
20:30:00
20:29:00
20:28:00
20:27:00
20:26:00
20:25:00
0 20:24:00
0 20:23:00
2 20:22:00
10
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Neonatology/Biomedical Optics Research Laboratory
NewbornCare
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Challenge: Comfort and wearability If the monitoring system is not comfortabel, it will not be used. Textile solution for sensors
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Neonatology/Biomedical Optics Research Laboratory
Challenge: Energy consumption BodyPoweredSense
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Neonatology/Biomedical Optics Research Laboratory
Challenge: Data analysis and artificial intelligence • Incidence of false alarms: 85% • Idea: Use artificial intelligence (Fuzzy logic) to remove false alarms
Event
Identified
Missed
Apnea
6
0
Bradycardia
6
0
Apnea & bradycardia combined
7
0
Critical situation
14
0
False alarm
174
1
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(ClinO/KlinV/OClin) the SPIRIT statement and ICH-GCP E6, section 6 EN ISO14155:2011: Annex A Swiss clinical trials portal (http://www.kofam.ch/en/swiss-clinical-trials-portal.html)
This template attempts to provide a general format applicable to all clinical trials evaluating an investigational productOptics (drugs or Research medical devices). Neonatology/Biomedical Laboratory Note that instructions are indicated in blue italics and they need be deleted (or alternatively may be formatted as “hidden Text” that will not show in printing).
Section headings and template text formatted in Challenge: Regulatory affairs requirements. This text may be deleted.
regular type red gives you reference to the legal
Section headings and template text formatted in regular type (black) should be included in your protocol document as provided in the template. Header and footer should contain the following information (on all pages): [Protocol Title], [Page x of
xx], [version x, DD/MM/YYYY], [Study ID] • New law on human research requires In places where the information is redundant, it is acceptable to reference extensive paperwork document or to state its redundancy but the section has not to be deleted.
another section, to
questions regarding use of this protocol template to swissethics/AGEK, info@swissethics.ch, • EthicalRefer committees medical devices phone: +41 (41) 440 26treat 67, www.swissethics.ch. similar to medication (risk category C)
• Medical devices without CE mark require notification of Swissmedic (Heilmittel) • Does the device lead to a treatment? Clinical Study Protocol
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final V_02, 30.11.2014
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Neonatology/Biomedical Optics Research Laboratory
Challenge: Reliability • Determine sensitivity and specificity: • Sensitivity = # true positives detected / # all positives • Specificity = # true negatives detected / # all negatives • Optimally both 100% • False alarms are costly • Technical reliability • E.g. battery expiry
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Neonatology/Biomedical Optics Research Laboratory
Challenge Intervention • What do you do, if the device detects an alarm situation? • The doctor will be called…. • ParaTex: The patient will be alarmed and can handle the situation himself
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Neonatology/Biomedical Optics Research Laboratory
Challenge: The user • Elderly patients: • Mind: • It the patient able to operate the device? • Recharging batteries • Exposing the device to unfavorable conditions (e.g. washing, heat) • Cannot replace the physician! • Soul: Does the patient feel safe, comfortable? • Body: Miniaturized device: can the patient read the messages and discern the keys? (e.g mobile phone) • Is the financial burden acceptable?
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Conclusion • Health monitoring is a field with tremendous potential • For effectiveness, needed: • Relevant application (interdisciplinary collaboration): Benefit for patient needed • Realistic knowledge of the application (interdisciplinary collaboration) • Mechanism of funding for interdisciplinary projects is important
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