REmote Data Acquisition After SURgery | Clinical Trial

Key information

Conditions

Visceral and Digestive Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service de Chirurgie Digestive et Endocrinienne, NHC

Strasbourg, 67000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remote Automated Monitoring System

Other

The patient will be monitored with conventional monitoring devices as well as the MultiSense patch

Primary outcomes

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.

Time frame: from patch placement to hospital discharge, assessed up to 1 week

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.
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.

Time frame: from patch placement to hospital discharge, assessed up to 1 week

Connectivity is defined as a time-wise ratio of missing versus total signal less than 20 percent.
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.

Time frame: from patch placement to hospital discharge, assessed up to 1 week

The generation of artefact data is defined as a percentage of outlier data less than 10 percent.
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.

Time frame: from patch placement to hospital discharge, assessed up to 1 week

Data transmission stability is defined as a data transmission rate equal to or greater than 80 percent.

Secondary outcomes

Usability of a data acquisition patch by health care providers (HCPs) in different hospital settings assessed via questionnaires.

Time frame: At hospital discharge, up to 7 days after the patch placement

Descriptive determination of user-friendliness, comprehensibility and ease of placement, connection and removal of the data acquisition patch by healthcare providers.
User experience of surgical patients with the continuous use of a data acquisition patch during remote postoperative monitoring assessed via patient's final questionnaires.

Time frame: From patch placement to its removal (7 days)

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).
Assess patients' tolerability to prolonged use of an adhesive patch during remote postoperative monitoring.

Time frame: From patch placement to its removal (7 days)

Number of unexpected local and distant events attributable to the use of the adhesive data acquisition patch.

Sponsors and collaborators

Lead sponsor

IHU Strasbourg

Other

Collaborators

Rhythm Diagnostic Systems

Registry information

Official study title

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

Acronym: REDASUR

Important dates

Study start: 2020
Primary completion: 2022
Study completion: 2022
First posted: Jul 21, 2020
Registry last updated: Feb 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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View Trial Details