Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
63 participants
INTERVENTIONAL
2020-12-07
2022-05-20
Brief Summary
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Detailed Description
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The aim of this study is to determine the quality of measurements of clinical signs provided by MultiSense® strip in comparison to measurements made with conventional medical devices in the hospital setting, in terms of accuracy, connectivity, generation of artefactual data and stability of data transmission. The study population includes 60 patients undergoing visceral or digestive surgery. Once in the post-operative monitoring room, the MultiSense® strip will be attached on patient's thorax. The monitoring will last 7 days through post-operative monitoring room (continuous comparison with reference monitor), general ward (comparison with spot-check monitoring) and patient's home.
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Remote Automated Monitoring System
MultiSense® strip will be attached on patient's thorax. The monitoring will last 7 days through post-operative monitoring room (continuous comparison with reference monitor), general ward (comparison with spot-check monitoring) and patient's home
Remote Automated Monitoring System
The patient will be monitored with conventional monitoring devices as well as the MultiSense patch
Interventions
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Remote Automated Monitoring System
The patient will be monitored with conventional monitoring devices as well as the MultiSense patch
Eligibility Criteria
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Inclusion Criteria
* Patient programmed for an elective in-ward surgery
* Patient located in Strasbourg area
* Patient with Wi-Fi and/or Cellular connectivity at home
* Patient able to receive and understand information related to the study and give written informed consent.
* Patient affiliated to the French social security system
Exclusion Criteria
* Patient with an implantable device such as a pacemaker
* Pregnant or lactating patient
* Patient in exclusion period (determined by a previous or a current study)
* Patient under guardianship or trusteeship
* Patient under the protection of justice
18 Years
ALL
No
Sponsors
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Rhythm Diagnostic Systems
INDUSTRY
IHU Strasbourg
OTHER
Responsible Party
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Principal Investigators
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Michel VIX, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Service de Chirurgie Digestive et Endocrinienne, NHC, Strasbourg
Locations
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Service de Chirurgie Digestive et Endocrinienne, NHC
Strasbourg, , France
Countries
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Other Identifiers
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19-009
Identifier Type: -
Identifier Source: org_study_id
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