REmote Data Acquisition After SURgery (REDASUR)

IHU Strasbourg

Status: Completed

Conditions: Visceral and Digestive Surgery

Treatments: Other: Remote Automated Monitoring System

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04480385

19-009

Details and patient eligibility

About

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.

Full 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.

Enrollment: 63 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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63 participants in 1 patient group

Remote Automated Monitoring System

Experimental group

Description:

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

Treatment:

Other: Remote Automated Monitoring System