Trådløs EKG løsning Noen erfaringer fra klinisk utprøving av ny trådløs EKG sensor Rune Fensli Førsteamanuensis Universitetet i Agder Fakultet for Teknologi og Realfag Grimstad, Norge rune.fensli@uia.no Trondheim 23.09-2008
Agenda Erfaringer fra klinisk utprøving Aktuelle anvendelsesområder Status for teknologi utviklingen Utfordringer Rune Fensli, 2008 2
The wireless ECG sensor A new wireless ECG recorder has been developed and clinically tested The patient will wear a totally wireless ECG sensor, to be fastened at the chest A dedicated Receiver device need to be carried by the patient While using the wireless ECG sensor: The patient can be able to carry out normal daily life activities The patient can participate in * The physical Research exercises Council of Norway has supported this project financially: FORNY project 2003, MEDKAP I and II 2004-06 during clinical trials The patient is allowed to take a shower while being monitored Patients at Sørlandet Hospital, Arendal have participated in the study as a part of their arrhythmia investigation at the hospitals outpatient clinic (2007-08) The wireless sensor attached to the chest The receiver device (to right) Rune Fensli, 2008 3
Evaluation of the wireless system versus Holter ECG sequences from both a Holter recorder and the wireless systems were compared by two independent cardiology specialists They gave their scores (1 5) evaluating the quality in the recording curve regarding its usefulness in arrhythmia diagnostics The figure shows three lead ECG from the Holter, and the wireless ECG-recorder Patient ID 02 Rune Fensli, 2008 4
Clinical evaluation The recording quality of an ECG recording may vary (as a result of patients movement and physical activity), and at total of 103 recorded ECG sequences of 30 seconds duration were evaluated. The doctors gave their scores evaluating the quality in the recording curve regarding its usefulness in arrhythmia diagnostics, given as 5-point Likert scale (5-Very Good, 4-Good, 3-Acceptable. 2-Poor, 1-Not Acceptable). Evaluated factor Total score Holter Wireless N Mean SD N Mean SD N Mean SD Usefulness in arrhythmia diagnostics 103 3.45 0.98 44 3.60 1.00 59 3.34 0.96 The cardiologists evaluations showed that the difference between the two recording systems was minimal and not at a statistical significant level. The wireless systems showed some improvements when the patient carried out physical activities (aerobics, football game, outdoor jogging etc.) Rune Fensli, 2008 5
Correlation of R-R intervals 1200 Correlation of R R intervals 1100 Wireless Sensor recordings 1000 900 800 700 600 500 400 400 500 600 700 800 900 1000 1100 1200 Holter recordings Correlation plot with R-R intervals in the continuous sequence of 131 heartbeats showed a strong correlation close to a straight line (r=0.998, p<0.005). Rune Fensli, 2008 6
A typical wireless ECG recording event A typical arrhythmia event is shown (Patient ID 71, recorded 20.11-2006) An extra systole causes the start of a supraventricular tachycardia, followed by some long pauses (up to 3.6 sec) HR 54.5 HR 102.7 Rune Fensli, 2008 7
Patient Acceptance A Sensor Acceptance Index is defined based on questionnaires (36 patients) General characteristics and Dimensions Sensor Acceptance Index (SAI) ranged from 2.7 to 10.0, (Mean 7.8, SD=1.7) Hygienic Aspects showed a higher score for the wireless group, F(1,34)=4.51 (p<0.05) Wireless Sensor (n=11) Reference Group (n=25) Gender: Man/woman 6 / 5 7 / 18 Age 40.2 (19.4) 56.4 (13.2) SAI 8.2 (1.0) 7.6 (1.9) 1. Hygienic Aspects 8.6 (1.6) 6.6 (2.9) * Skin Reaction showed a higher 2. Physical Activity 9.2 (0.8) 8.0 (2.8) score for the reference group, F(1,32)=5.95 (p<0.05) 3. Skin Reactions 6.3 (2.5) 8.6 (2.4) * High scores of Anxiety 4. Anxiety 9.0 (1.3) 7.3 (3.5) Indicating low degree of 5. Equipment 8.0 (1.7) 7.5 (2.8) anxiety * Significant difference, p<.05 Fensli R, Pedersen PE, Gundersen T, Hejlesen O. Sensor Acceptance Model - Measuring Patient Acceptance of Wearable Sensors. Methods Inf Med. 2008;47(1):89-95. Rune Fensli, 2008 8
Erfaringer fra desentralisert arytmi diagnostikk Den trådløse teknologien har vært utplassert ved fastlegekontorer: Tromøy Legesenter, Legegruppen Grandgården Pasienten har fått påsatt trådløs sensor hos sin fastlege Kardiolog ved Sørlandet Sykehus HF, Arendal har forestått diagnostisering Erfaringer: Pasienten kan raskere få avklart en arytmidiagnostikk (dager ~ uker) Stor grad av pasient tilfredshet Ønske om å utvikle telemedisinske løsninger Ventetid for pasienter til arytmidiagnostikk ved Sørlandet Sykehus HF, Arendal N=36 Rune Fensli, 2008 9 % of patients 35 30 25 20 15 10 5 0 Waiting time in days/weeks 1 3 Days 4 7 Days 1 2 Weeks 2 4 Weeks >4 Weeks
Prosjekt: Trådløs overvåkning i pasienthotell OFU-Prosjekt ved Sørlandet Sykehus HF Behovsdrevet innovasjon (rapport SSHF 15.10-2007) Etablering av trådløs overvåkning for pasienter i pasienthotell Arytmi alarmer overvåkes ved hjerteovervåkningen Teknologien er under utvikling Rutiner for pasientoppfølging planlegges Pasientforløp i sykehuset vurderes Systemet skal evalueres: Brukervennlighet Medisinske anvendelser og effekter i pasientbehandlingen Kommersielle forhold/ markedsmessige aspekt Rune Fensli, 2008 10
Aktuelle kliniske anvendelser Tidlig og rask arytmi diagnostikk Kan forestås som en desentralisert arytmi diagnostikk Pasienter med mistanke om en arytmi Kontroll av medisinering for pasienter med kjent arytmi Mulig å korrelere arytmi og fysisk aktivitet Overvåkning av pasienter etter sykehusbehandling Observasjonsposter og pasienthotell Kan følge pasienten ut av sykehuset: Sykehjem/omsorgssentra Overvåkning av pasienter i eget hjem Telehomecare Rune Fensli, 2008 11
Curvus konseptet fra WPR Medical Teknologien vil bli introdusert i markedet under produktnavnet Curvus Trådløs sensor og mottaker er knyttet opp i et BAN Arytmi eventer sendes automatisk til legen via GPRS www.curvus.no www.wprmedical.no About time you set the patient free? Rune Fensli, 2008 12
Future Tele-Home-Care Services Fensli R, Gunnarson E, Gundersen T. A wearable ECG-recording System for Continuous Arrhythmia Monitoring in a Wireless Tele-Home-Care Situation. Proceedings 18th IEEE Symposium on Computer- Based Medical Systems; 2005 June 23-24; Dublin, Ireland; 2005. p. 407-12. Wireless transfer of encountered ECG-alarm situations Base station for Mobile telephone GPRS/ GSM INTERNET WPR Internet connected server Remote WPR Client at the hospital The patient is wearing the WPR wireless ECG-sensor The Hand-Held device receives ECG-signals and uses automatic arrhythmia detection algorithms The patient can use a web-based system to contact the doctor and read the encountered ECG-findings The Doctor at the Hospital can make diagnositc evaluations of the recorded ECG-signals Rune Fensli, 2008 13
Erfaringer om aktuelle hindringer ~ utfordringer Synliggjøre kostnadseffektive behandlingsformer med ny teknologi Standardisering, integrering, samhandling Medisinsk akseptants av ny teknologi Endring i ansvarsforhold for diagnostikk og overvåkning Oppgjørsformer i helsevesenet hinder effektive løsninger fordi det berører endringer i ulike helsetjeneste nivåer (telemedisinske takster) Hvordan kan sykehuset få kostnadsdekning når pasienten ikke lenger er på sykehuset? Hvordan kan Fastlegen få kostnadsdekning når kardiologen er involvert i diagnostikk? Holdninger i forhold til ansvarsfordeling og samhandling Hvordan kan informasjonen flyte raskt mellom kommunehelsetjenesten Fastlegen kardiolog på sykehuset? Hvordan få en mer effektiv pasientflyt? Hvordan kan pasienten få medinnflytelse og økt ansvar Rune Fensli, 2008 14
Acknowledgements Arbeidet er utført med støtte fra: Norges Forskningsråd FORNY programmet 2002-03 MEDKAP 2004-06 BIP 2006-07 Innovasjon Norge OFU avtale Aust-Agder Kompetansefond Sørlandets Teknologisenter Agder Medforsk Sørlandet Sykehus HF, Arendal Tromøy Legesenter, Legegruppen Grandgården WPR Medical AS Rune Fensli, 2008 15
Spørsmål?? Kontakt info: Rune Fensli Universitetet i Agder, Fakultet for Teknologi og Realfag Grooseveien 36, Grimstad Tel: 3725 3373 Email: rune.fensli@uia.no Rune Fensli, 2008 16
Rune Fensli, 2008 17