- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT04053179
Validation of a Connected Patch, an Alternative to Conventional Monitoring
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
-
Suresnes, France, 92150
- Hopital Foch
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: Validation des correctifs connectés
|
Utilisation du patch connecté pour recueillir la tension artérielle, la fréquence cardiaque, la fréquence respiratoire, la saturation artérielle en oxygène et la température
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Concordance of blood pressure value measured by 2 different devices after surgery
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Concordance of blood pressure value measured by 2 different devices during surgery
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: During surgery
|
Comparison between temperature value measured by conventional medical monitoring device and by connected patch
|
During surgery
|
Blood pressure artifact
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
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During the surgery and through study completion
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Morgan Le Guen, Hopital Foch
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Anticipé)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- 2017055F
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
produit fabriqué et exporté des États-Unis.
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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