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Validation of a Connected Patch, an Alternative to Conventional Monitoring

3. Februar 2020 aktualisiert von: 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.

Studienübersicht

Status

Zurückgezogen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

      • Suresnes, Frankreich, 92150
        • Hôpital Foch

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 85 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Sonstiges
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Verbundene Patch-Validierung
Verwendung eines angeschlossenen Pflasters zur Erfassung von Blutdruck, Herzfrequenz, Atemfrequenz, arterieller Sauerstoffsättigung und Temperatur

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Concordance of blood pressure value measured by 2 different devices after surgery
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Concordance of blood pressure value measured by 2 different devices during surgery
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: During surgery
Comparison between temperature value measured by conventional medical monitoring device and by connected patch
During surgery
Blood pressure artifact
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Ermittler

  • Hauptermittler: Morgan Le Guen, Hôpital Foch

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Voraussichtlich)

1. Januar 2020

Primärer Abschluss (Voraussichtlich)

4. September 2020

Studienabschluss (Voraussichtlich)

4. September 2020

Studienanmeldedaten

Zuerst eingereicht

6. August 2019

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

9. August 2019

Zuerst gepostet (Tatsächlich)

12. August 2019

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

5. Februar 2020

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

3. Februar 2020

Zuletzt verifiziert

1. August 2019

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • 2017055F

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

Nein

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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