Visceral and Digestive Surgery
Conditions
Keywords
Vital signs, Connected device, real-time monitoring, post-surgery monitoring, cardio-respiratory monitoring
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.
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.
Interventions
The patient will be monitored with conventional monitoring devices as well as the MultiSense patch
Sponsors
Rhythm Diagnostic Systems
IHU Strasbourg
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. | 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. | 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. | 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
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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. | 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. |
| 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 | Descriptive determination of user-friendliness, comprehensibility and ease of placement, connection and removal of the data acquisition patch by healthcare providers. |
Countries
France
Outcome results
None listed