Smart Pain Assesment Tool Based on Internet of Things (SPA)
21. desember 2018 oppdatert av: Sanna Salanterä, University of Turku
This study is the second phase of a research project called "Smart Pain Assessment Tool based on Internet-of-Things".
During the course of this project, a smart pain assessment tool (SPA) to detect and assess pain employing behavioural and physiologic indicators will be developed.
We aim to assess pain based on changes in electromyographic (EMG) activity in facial muscles, i.e. changes in facial expressions and simultaneously use physiologic signs such as heart rate, respiratory rate and galvanic skin response as adjuvant measures to develop an algorithm for pain assessment in critically ill patients.
Studieoversikt
Detaljert beskrivelse
The aim of this "smart pain assessment tool based on internet of things" SPA-research project is to develop an automatic and versatile pain assessment tool algorithm for detection and assessment of pain in a reliable and objective way in non-communicative patients.
The final objective of the research project is to develop a smart pain assessment tool to detect and assess pain employing behavioural and physiologic indicators for a wide range of users/patients from infants to elderly people who are unable to communicate normally.
The research project consists of three clinical phases (European Commision.
Meddev 2.7/4/2010).
The clinical phase I of the research project focused on developing pain assessment techniques involuntary working-age healthy study subjects.
This current Clinical phase II includes the further development and research of the smart pain assessment tool in elective (non emergency) postoperative surgical patients during their stay after surgery in a recovery room.
Studietype
Intervensjonell
Registrering (Faktiske)
58
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Turku, Finland, 20140
- University of Turku
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Subject is scheduled for major surgery that requires general anesthesia and is likely to cause moderate to severe pain postoperatively which needs to be treated with systemic analgesics
- Ability to communicate
- Written informed consent
- Healthy facial skin
Exclusion Criteria:
- Subject treated with local anesthesia during surgery
- Any diagnosed condition affecting cognitive functions
- Surgery affecting hands where pulse oximetry and galvanic skin reaction are recorded or areas where facial muscle activity is measured
- Any diagnosed condition affecting central nervous system, facial nerves or muscles.
- Significant facial hair growth in the area where the sensors will be attached
- Tattoos in the area where the sensors will be attached
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Diagnostisk
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Postoperative patients
We recruit postoperative patients who undergo open surgery and are not receiving local anesthesia.
We install a smart pain assessment tool on patient's skin to capture different type of data.
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We record and analyze multiple bio-signals from post-operative patients in the attempt to evaluate their experienced pain.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Facial muscle activity
Tidsramme: 2 hours after surgery when the subject has woken up
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The device is designed for multi-channel EMG acquisition from facial skin.
Measuring a combination of EMG signals and their energy level (amplitude).
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2 hours after surgery when the subject has woken up
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Skin conductance
Tidsramme: 2 hours after surgery when the subject has woken up
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Galvanic skin response (GSR), also known as electrodermal activity (EDA) or skin conductance (SC).
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2 hours after surgery when the subject has woken up
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Pain assesment by VAS
Tidsramme: 2 hours after surgery when the subject has woken up
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Subjective feeling of pain is asked every 10 minutes by using numeric visual analog scale (VAS), values are given from 0-10.
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2 hours after surgery when the subject has woken up
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Heart rate
Tidsramme: 2 hours after surgery when the subject has woken up
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Heart rate is monitored and recorded.
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2 hours after surgery when the subject has woken up
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Respiratory rate
Tidsramme: 2 hours after surgery when the subject has woken up
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Respiratory rate is monitored and recorded.
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2 hours after surgery when the subject has woken up
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Oxygen saturation
Tidsramme: 2 hours after surgery when the subject has woken up
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Oxygen saturation is monitored and recorded.
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2 hours after surgery when the subject has woken up
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Sanna Salanterä, Prof, University of Turku
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Viertio-Oja H, Maja V, Sarkela M, Talja P, Tenkanen N, Tolvanen-Laakso H, Paloheimo M, Vakkuri A, Yli-Hankala A, Merilainen P. Description of the Entropy algorithm as applied in the Datex-Ohmeda S/5 Entropy Module. Acta Anaesthesiol Scand. 2004 Feb;48(2):154-61. doi: 10.1111/j.0001-5172.2004.00322.x. No abstract available.
- Jeitziner MM, Schwendimann R, Hamers JP, Rohrer O, Hantikainen V, Jakob SM. Assessment of pain in sedated and mechanically ventilated patients: an observational study. Acta Anaesthesiol Scand. 2012 May;56(5):645-54. doi: 10.1111/j.1399-6576.2012.02660.x. Epub 2012 Mar 7.
- Prkachin KM. Assessing pain by facial expression: facial expression as nexus. Pain Res Manag. 2009 Jan-Feb;14(1):53-8. doi: 10.1155/2009/542964.
- Ledowski T, Ang B, Schmarbeck T, Rhodes J. Monitoring of sympathetic tone to assess postoperative pain: skin conductance vs surgical stress index. Anaesthesia. 2009 Jul;64(7):727-31. doi: 10.1111/j.1365-2044.2008.05834.x. Epub 2009 Jan 28.
- EPoSS. 2008. Internet of Things in 2020: a Roadmap for the Future. European Technology Platform on Smart Systems Integration. European Commission Information Society.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
20. november 2017
Primær fullføring (Faktiske)
11. juni 2018
Studiet fullført (Faktiske)
11. juni 2018
Datoer for studieregistrering
Først innsendt
9. februar 2017
Først innsendt som oppfylte QC-kriteriene
17. februar 2017
Først lagt ut (Faktiske)
23. februar 2017
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
24. desember 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
21. desember 2018
Sist bekreftet
1. desember 2018
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- 29092016
Plan for individuelle deltakerdata (IPD)
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Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
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Nei
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