REmote Data Acquisition After SURgery (REDASUR)

Study of the Technological and Operational Feasibility of a Remote Automated Monitoring System for the Post-operative Care of Surgical Patients

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.

Study Overview

• Status: Completed
• Conditions: Visceral and Digestive Surgery
• Intervention / Treatment: Other: Remote Automated Monitoring System

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.

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Strasbourg, France, 67000
    • Service de Chirurgie Digestive et Endocrinienne, NHC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Other: Remote Automated Monitoring System; The patient will be monitored with conventional monitoring devices as well as the MultiSense patch

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Accuracy is defined as an average measurement variation less than 3.5 percent or 5 percent of the mean value, depending on the variable with respect to the reference standard.	from patch placement to hospital discharge, assessed up to 1 week
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.	Connectivity is defined as a time-wise ratio of missing versus total signal less than 20 percent.	from patch placement to hospital discharge, assessed up to 1 week
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.	The generation of artefact data is defined as a percentage of outlier data less than 10 percent.	from patch placement to hospital discharge, assessed up to 1 week
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.	Data transmission stability is defined as a data transmission rate equal to or greater than 80 percent.	from patch placement to hospital discharge, assessed up to 1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Usability of a data acquisition patch by health care providers (HCPs) in different hospital settings assessed via questionnaires.	Descriptive determination of user-friendliness, comprehensibility and ease of placement, connection and removal of the data acquisition patch by healthcare providers.	At hospital discharge, up to 7 days after the patch placement
User experience of surgical patients with the continuous use of a data acquisition patch during remote postoperative monitoring assessed via patient's final questionnaires.	Descriptive determination of user experience and practicalities associated with wearing the data acquisition patch (e.g. portability, duration of skin adhesion, anticipated detachment, interference with activities and stigma perception).	From patch placement to its removal (7 days)
Assess patients' tolerability to prolonged use of an adhesive patch during remote postoperative monitoring.	Number of unexpected local and distant events attributable to the use of the adhesive data acquisition patch.	From patch placement to its removal (7 days)

Collaborators and Investigators

• Sponsor: IHU Strasbourg
• Collaborators: Rhythm Diagnostic Systems
• Investigators: Principal Investigator: Michel VIX, MD, PhD, Service de Chirurgie Digestive et Endocrinienne, NHC, Strasbourg

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2020
• Primary Completion (Actual): May 20, 2022
• Study Completion (Actual): May 20, 2022

Study Registration Dates

• First Submitted: July 8, 2020
• First Submitted That Met QC Criteria: July 16, 2020
• First Posted (Actual): July 21, 2020

Study Record Updates

• Last Update Posted (Actual): February 24, 2023
• Last Update Submitted That Met QC Criteria: February 23, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Vital signs; Connected device; real-time monitoring; cardio-respiratory monitoring; post-surgery monitoring
• Other Study ID Numbers: 19-009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No