Monitoring, Physiologic Clinical Trial
— LYNG21Official title:
ABLY LYNG Study at Helse More Romsdal - Aalesund Sykehus HMR With the Ably LYNG Patient Care Solution Advanced Prototype by Ably Medical AS.
Verified date | October 2021 |
Source | Ably Medical AS |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Enrolling by invitation |
Enrollment | 20 |
Est. completion date | December 31, 2021 |
Est. primary completion date | December 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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/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 |
Country | Name | City | State |
---|---|---|---|
Norway | Helse Møre og Romsdal HF - Aalesund Sjukehus | Ålesund |
Lead Sponsor | Collaborator |
---|---|
Ably Medical AS | Alesund Hospital |
Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Absolute Relative Error of Heart Rate (beats per minute) | absolute relative error = (reference measure/LYNG measure)/Reference | 60 minutes | |
Primary | Absolute Relative Error of Respiration Rate (respirations per minute) | absolute relative error = (reference measure/LYNG measure)/Reference | 60 minutes | |
Primary | Movement | Comparison of movement as part of patient instruction compared to indications of movement in movement sensors. Qualitative analysis. | 60 minutes | |
Primary | 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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