Visceral and Digestive SurgeryREDASURNCT04480385
REmote Data Acquisition After SURgery
A study testing Remote Automated Monitoring System in people with Visceral and Digestive Surgery, run by IHU Strasbourg at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Visceral and Digestive Surgery
- What is being tested?
- Remote Automated Monitoring System
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteFrance
- Study dates
- 7 Dec 2020to 20 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
France1 site
Service de Chirurgie Digestive et Endocrinienne, NHC
Strasbourg, 67000
About this study
Official title: 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.
Read the 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.
- Conditions
- Visceral and Digestive Surgery
- Being tested
- Remote Automated Monitoring System
- Keywords
- Vital signs, Connected device, real-time monitoring, post-surgery monitoring, cardio-respiratory monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Automated Monitoring SystemOther
The patient will be monitored with conventional monitoring devices as well as the MultiSense patch
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Remote Automated Monitoring System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Descriptive determination of user-friendliness, comprehensibility and ease of placement, connection and removal of the data acquisition patch by healthcare providers.
Measured: 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).
Measured: 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.
Measured: From patch placement to its removal (7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2020
- Study start7 Dec 2020
- Primary completion20 May 2022
- Study completion20 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visceral and Digestive SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- IHU Strasbourg
- Sponsor type
- University, hospital or other
- Collaborators
- Rhythm Diagnostic Systems
- Responsible party
- Sponsor
- Investigators
- Michel VIX, MD, PhD, Principal investigator, Service de Chirurgie Digestive et Endocrinienne, NHC, Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04480385
- Sponsor's protocol ID
- 19-009
- Acronym
- REDASUR
- Status last verified
- Feb 2023
- First submitted
- 8 Jul 2020
- Last updated
- 24 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Technological and Operational Feasibility of a Remote Automated Monitoring System for the Post-operative Care of Surgical Patients
- ClinicalTrials.gov ID
- NCT04480385
- Acronym / sponsor ID
- REDASUR / 19-009
- Conditions
- Visceral and Digestive Surgery
- Keywords
- Vital signs, Connected device, real-time monitoring, post-surgery monitoring, cardio-respiratory monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- IHU StrasbourgUniversity, hospital or other
- Collaborators
- Rhythm Diagnostic Systems
- Study start
- 7 Dec 2020 (actual)
- Primary completion
- 20 May 2022 (actual)
- Study completion
- 20 May 2022 (actual)
- First posted
- 21 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Remote Automated Monitoring System | Experimental | Other: Remote Automated Monitoring SystemMultiSense® 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote Automated Monitoring SystemThe patient will be monitored with conventional monitoring devices as well as the MultiSense patch | Other | Remote Automated Monitoring System |
Primary outcome
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.
3 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
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)
Assess patients' tolerability to prolonged use of an adhesive patch during remote postoperative monitoring.
Time frame: From patch placement to its removal (7 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michel VIX, MD, PhD principal investigator
Service de Chirurgie Digestive et Endocrinienne, NHC, Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote Automated Monitoring System in people with Visceral and Digestive Surgery, run by IHU Strasbourg at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: from patch placement to hospital discharge, assessed up to 1 week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2023.