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| Name | Class |
|---|---|
| Alesund Hospital | OTHER |
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The study main objective will be to compare measurements of heart rate, respiration rate, blood pressure and movement done by LYNG by Ably Medical with the corresponding measurements made by standard equipment in a patient sample in a hospital setting. The comparison will show the degree of agreement between LYNG and the existing current standard equipment. Data from the study will support Ably Medical in optimizing the LYNG product and measurement precision.
The LYNG sensor mat is placed beneath a regular bed matrass and captures data without direct patient contact. Data collected by the LYNG sensor is transmitted via cables to the bed-side connectivity box for initial local analysis and storage. Data will be extracted and formatted for post-analysis in additional software for verification and validation purposes.
Specifically, the LYNG study objectives are as follows:
The study design is a within-subjects comparison in parameter estimation with Ably LYNG as comparator to standard of care. Patients will take part in 60-minute sessions where measurements are collected in accidence to standard procedure for the standard equipment while the LYNG system collects the same data non- intrusively. The data will not be part of any clinical decision making or have any impact of the patient care. The study will take place during Q2-Q3/2021 with estimated 8-12 weeks duration including logistics, setup, data collection, study closure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitalsigns | Other | Data from patients (heart rate, respiration, movement, blood pressure) is measured with traditional, standard hospital equipment in parallell with data from LYNG mat captured non-intrusively in the same session. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LYNG by Ably Medical | Device | Comparing LYNG to traditional, standard equipment for heart rate, respiration, movement, and blood pressure. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Absolute Relative Error of Heart Rate (beats per minute) | absolute relative error = (reference measure/LYNG measure)/Reference | 60 minutes |
| Absolute Relative Error of Respiration Rate (respirations per minute) | absolute relative error = (reference measure/LYNG measure)/Reference | 60 minutes |
| Movement | Comparison of movement as part of patient instruction compared to indications of movement in movement sensors. Qualitative analysis. | 60 minutes |
| absolute relative error of Blood Pressure = (reference measure/LYNG measure)/Reference | absolute relative error = (reference measure/LYNG measure)/Reference Sphygmomanometer, millimeters of mercury (mmHg) upper (systolic), lower (diastolic), and mean value. | 60 minutes |
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Inclusion Criteria:
For patients:
Exclusion Criteria:
For patients:
The nurse handing recruitment will explicitly check for inclusion/exclusion criteria alignment and document this in the study Enrolment Form. The routine will be to check for formal criteria and to describe the study in such a manner that the patient understands content, and make sure the patient understands before consenting
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| Name | Affiliation | Role |
|---|---|---|
| Dag A Lihaug Hoff | HMR Aalesund Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helse Møre og Romsdal HF - Aalesund Sjukehus | Ålesund | 6026 | Norway |
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Within subject comparison - of two screening methodologies (standard equipment with direct patient sensors vs LYNG contactless sensors). The number patients in the study is chosen to have a broad view on patients population found in a general hospital setting, for example a range of height, weight, gender, age.
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