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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
63
The patient will be monitored with conventional monitoring devices as well as the MultiSense patch
Service de Chirurgie Digestive et Endocrinienne, NHC
Strasbourg, France
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: from patch placement to hospital discharge, assessed up to 1 week
Usability of a data acquisition patch by health care providers (HCPs) in different hospital settings assessed via questionnaires.
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Descriptive determination of user-friendliness, comprehensibility and ease of placement, connection and removal of the data acquisition patch by healthcare providers.
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.
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).
Time frame: 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.
Time frame: From patch placement to its removal (7 days)