NCT04480385

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 21, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

December 7, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2022

Completed
Last Updated

February 24, 2023

Status Verified

February 1, 2023

Enrollment Period

1.4 years

First QC Date

July 8, 2020

Last Update Submit

February 23, 2023

Conditions

Visceral and Digestive Surgery

Keywords

Vital signsConnected devicereal-time monitoringpost-surgery monitoringcardio-respiratory monitoring

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (3)

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

    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.

    From patch placement to its removal (7 days)

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

    From patch placement to its removal (7 days)

Study Arms (1)

Remote Automated Monitoring System

EXPERIMENTAL

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

Interventions

Remote Automated Monitoring SystemOTHER

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

Remote Automated Monitoring System

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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 under guardianship or trusteeship
  • Patient under the protection of justice

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Chirurgie Digestive et Endocrinienne, NHC

Strasbourg, 67000, France

Location

Study Officials

  • Michel VIX, MD, PhD

    Service de Chirurgie Digestive et Endocrinienne, NHC, Strasbourg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2020

First Posted

July 21, 2020

Study Start

December 7, 2020

Primary Completion

May 20, 2022

Study Completion

May 20, 2022

Last Updated

February 24, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)