Clinical trial NCT04480385: REmote Data Acquisition After SURgery
Official title: Study of the Technological and Operational Feasibility of a Remote Automated Monitoring System for the Post-operative Care of Surgical Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Visceral and Digestive Surgery
Keywords: Vital signs
Connected device
real-time monitoring
post-surgery monitoring
cardio-respiratory monitoring
Lead sponsor: IHU Strasbourg
Sponsor class: OTHER
Collaborators: name: Rhythm Diagnostic Systems
First posted: 2020-07-21
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: In this clinical study, the investigators will compare vital parameters measurements obtained using continuous data from reference monitors and continuous wireless MultiSense® monitoring patch in 60 patients immediately after in-ward surgery and over 7 days.

Detailed description: The MultiSense® strip is a unique, band aid-sized, clinical signal quality, connected strip for real-time monitoring of cardio-respiratory parameters. The MultiSense® strip measures in real-time, remotely and continuously 11 clinical key-indicators by being attached to the patient thorax: Electrocardiogram (ECG) trace, heart rate, oxygen saturation, respiratory rate and relative respiration depth, pulse transit time, plethysmographic trace, perfusion index, skin temperature, physical activity and body position. Designed to be worn continuously for at least seven days, the patient can keep the patch during his sleep or in the shower.

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.

Eligibility criteria: Inclusion Criteria:

* Man or woman over 18 years old
* 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 a skin disease that would not allow the use of an adhesive
* 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

Primary outcomes:
measure: Determination of 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.
timeFrame: from patch placement to hospital discharge, assessed up to 1 week
measure: Determination of 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 connectivity.
timeFrame: from patch placement to hospital discharge, assessed up to 1 week
measure: Determination of 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 generation of artefactual data.
timeFrame: from patch placement to hospital discharge, assessed up to 1 week
measure: Determination of 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 stability of data transmission.
timeFrame: from patch placement to hospital discharge, assessed up to 1 week
Secondary outcomes:
measure: Usability of a data acquisition patch by health care providers (HCPs) in different hospital settings assessed via questionnaires.
timeFrame: At hospital discharge, up to 7 days after the patch placement
measure: User experience of surgical patients with the continuous use of a data acquisition patch during remote postoperative monitoring assessed via patient's final questionnaires.
timeFrame: From patch placement to its removal (7 days)
measure: Assess patients' tolerability to prolonged use of an adhesive patch during remote postoperative monitoring.
timeFrame: From patch placement to its removal (7 days)
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Chirurgie Digestive et Endocrinienne, NHC
Study officials:
affiliation: Service de Chirurgie Digestive et Endocrinienne, NHC, Strasbourg
name: Michel VIX, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: