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Validation of a Connected Patch, an Alternative to Conventional Monitoring

3. februar 2020 oppdatert av: Hopital Foch
The hypothesis is that this connected patch could be used in surgical departments to detect early a cardiovascular or respiratory complication and therefore to treat it without delay. However, it has not been validated in a hospital setting; that is the purpose of this project. This step of validating the connected monitoring object is required in different places: post-interventional surveillance room that approaches a conventional hospital room, and operating room where artifacts are numerous. Validation will be done by comparing data from General Electric's conventional monitors, with data from patches.

Studieoversikt

Status

Tilbaketrukket

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

When patients operated on outside intensive care or intensive care units are hospitalized, vital signs are collected intermittently by various conventional devices. During the follow-up period of these patients, it is possible that abnormal vital signs that may identify clinical deterioration may appear a few minutes to a few hours before a serious adverse event (infection etc.) occurs. These signals often go unnoticed due to infrequent monitoring.

The establishment of teams to ensure a rapid response would improve the safety of hospitalized patients for whom the detection of abnormal vital signs predictive of clinical deterioration would generate an alarm. This system is based on the identification of patients at risk and the rapid intervention of the team.

One of the crucial issues is therefore the speed of the alarm and its reliability.

The evolution of electronic technology offers the possibility of using inexpensive portable devices (connected patches) that can provide information on vital signs in real time. Vital signs collected by these devices could be analyzed to predict clinical deterioration prior to hospital staff visits, especially at night and on weekends when staffing levels are generally lower.

The connected patch used in this research is the Scaléo Médical company's device "myAngel VitalSigns". The long-term objective would be to be able to use this connected patch in surgical departments to detect early a complication, particularly of a cardiovascular or respiratory nature, and therefore to treat it without wasting time. However, it has not been validated in a hospital setting; that is the purpose of the project.

The objective of this research is therefore to validate Scaléo Médical's connected patch in different locations: post-interventional surveillance room that approaches a conventional hospital room, operating room where artifacts are numerous.

Studietype

Intervensjonell

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

      • Suresnes, Frankrike, 92150
        • Hôpital Foch

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 til 85 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • patient over 18 and under 85 years of age
  • patient requiring general anesthesia for extra-thoracic surgery
  • the patient's position during the operation is in supine position only
  • patient affiliated to or benefiting from social security, excluding State Medical Assistance
  • patient with written consent

Exclusion Criteria:

  • pregnant or breastfeeding patients
  • patients known to have severe skin reactions to adhésives
  • patient whose surgical procedure prevents the patch from being placed (intervention on the thorax)
  • patients deprived of their liberty or under guardianship

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Koblet oppdateringsvalidering
Bruk av tilkoblet plaster for å samle blodtrykk, hjertefrekvens, respirasjonsfrekvens, arteriell oksygenmetning og temperatur

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Concordance of blood pressure value measured by 2 different devices after surgery
Tidsramme: 36 hours maximum after the surgery
Comparison between blood pressure measured by conventional medical monitoring device and by connected patch
36 hours maximum after the surgery
Concordance of heart rate value measured by 2 different devices after surgery
Tidsramme: 36 hours maximum after the surgery
Comparison between heart rate measured by conventional medical monitoring device and by connected patch
36 hours maximum after the surgery
Concordance of respiratory rate value measured by 2 different devices after surgery
Tidsramme: 36 hours maximum after the surgery
Comparison between respiratory rate measured by conventional medical monitoring device and by connected patch
36 hours maximum after the surgery
Concordance of arterial oxygen saturation value measured by 2 different devices after surgery
Tidsramme: 36 hours maximum after the surgery
Comparison between arterial oxygen saturation measured by conventional medical monitoring device and by connected patch
36 hours maximum after the surgery
Concordance of temperature value measured by 2 different devices after surgery
Tidsramme: 36 hours maximum after the surgery
Comparison between temperature measured by conventional medical monitoring device and by connected patch
36 hours maximum after the surgery

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Concordance of blood pressure value measured by 2 different devices during surgery
Tidsramme: During surgery
Comparison between blood pressure measured by conventional medical monitoring device and by connected patch
During surgery
Concordance of heart rate value measured by 2 different devices during surgery
Tidsramme: During surgery
Comparison between heart rate measured by conventional medical monitoring device and by connected patch
During surgery
Concordance of respiratory rate value measured by 2 different devices during surgery
Tidsramme: During surgery
Comparison between respiratory rate measured by conventional medical monitoring device and by connected patch
During surgery
Concordance of arterial oxygen saturation value measured by 2 different devices during surgery
Tidsramme: During surgery
Comparison between arterial oxygen saturation measured by conventional medical monitoring device and by connected patch
During surgery
Concordance of temperature value measured by 2 different devices during surgery
Tidsramme: During surgery
Comparison between temperature value measured by conventional medical monitoring device and by connected patch
During surgery
Blood pressure artifact
Tidsramme: From surgery to 36 hours maximum after the surgery
Value of blood pressure will be considered as artifact if systolic blood pressure value < 80 or > 200 and diastolic blood pressure > 110
From surgery to 36 hours maximum after the surgery
Heart rate artifact
Tidsramme: From surgery to 36 hours maximum after the surgery
Value of heart rate will be considered as artifact if value < 40 or > 140
From surgery to 36 hours maximum after the surgery
Respiratory rate artifact
Tidsramme: From surgery to 36 hours maximum after the surgery
Value of respiratory rate will be considered as artifact if value < 8 or > 36
From surgery to 36 hours maximum after the surgery
Arterial oxygen saturation artifact
Tidsramme: From surgery to 36 hours maximum after the surgery
Value of arterial oxygen saturation will be considered as artifact if value < 85 %
From surgery to 36 hours maximum after the surgery
Acceptability of connected patch: numerical scale
Tidsramme: During the surgery and through study completion
Evaluation of connected patch with a simple numerical scale between 0 and 10: 0 representing a very poor tolerance of the device and leading to premature interruption of the collection and 10 a perfect tolerance allowing the patch to be maintained for several consecutive days
During the surgery and through study completion

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Etterforskere

  • Hovedetterforsker: Morgan Le Guen, Hôpital Foch

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 (Forventet)

1. januar 2020

Primær fullføring (Forventet)

4. september 2020

Studiet fullført (Forventet)

4. september 2020

Datoer for studieregistrering

Først innsendt

6. august 2019

Først innsendt som oppfylte QC-kriteriene

9. august 2019

Først lagt ut (Faktiske)

12. august 2019

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

5. februar 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. februar 2020

Sist bekreftet

1. august 2019

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • 2017055F

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

Nei

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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