Monitoring, Physiologic
Conditions
Keywords
non-intrusive monitoring
Brief summary
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.
Detailed description
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: 1. collect sensor data from LYNG Solution to optimize the LYNG data algorithms to further improve parameter estimations of patient heart rate, respiratory rate, blood pressure and movement indicators. 2. Compare parameter estimation by LYNG against current and relevant standard of care measurement methods 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.
Interventions
DEVICELYNG by Ably Medical
Comparing LYNG to traditional, standard equipment for heart rate, respiration, movement, and blood pressure.
Sponsors
Alesund Hospital
Ably Medical AS
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* For patients: * Admitted to hospital, * Able to provide voluntary, informed consent.
Exclusion criteria
* For patients: * Health condition that endangers patient by participation due to pain, rehabilitation, and/or negative impact on treatment or care, as evaluated by medical personnel, * Pregnancy, * Significantly reduced mobility that implies substantial strain for moving in and out of bed, as evaluated by medical personnel * Unable to provide informed, voluntary consent personally or by legal guardian, \* below 18 years old, * Patients with implantable devices such as pacemakers, baclofen pumps, insulin pumps, etc, or * Any way identified as 'vulnerable' The nurse handing recruitment will explicitly check for inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absolute Relative Error of Heart Rate (beats per minute) | 60 minutes | absolute relative error = (reference measure/LYNG measure)/Reference |
| Absolute Relative Error of Respiration Rate (respirations per minute) | 60 minutes | absolute relative error = (reference measure/LYNG measure)/Reference |
| Movement | 60 minutes | Comparison of movement as part of patient instruction compared to indications of movement in movement sensors. Qualitative analysis. |
| absolute relative error of Blood Pressure = (reference measure/LYNG measure)/Reference | 60 minutes | absolute relative error = (reference measure/LYNG measure)/Reference Sphygmomanometer, millimeters of mercury (mmHg) upper (systolic), lower (diastolic), and mean value. |
Countries
Norway
Outcome results
None listed