Clinical trial NCT05117606: LYNG21: Ably LYNG Clinical Demonstration in Operative Environment
Official title: ABLY LYNG Study at Helse More Romsdal - Aalesund Sykehus HMR With the Ably LYNG Patient Care Solution Advanced Prototype by Ably Medical AS.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Monitoring, Physiologic
Keywords: non-intrusive monitoring
Lead sponsor: Ably Medical AS
Sponsor class: INDUSTRY
Collaborators: name: Alesund Hospital
First posted: 2021-11-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Absolute Relative Error of Heart Rate (beats per minute)
timeFrame: 60 minutes
measure: Absolute Relative Error of Respiration Rate (respirations per minute)
timeFrame: 60 minutes
measure: Movement
timeFrame: 60 minutes
measure: absolute relative error of Blood Pressure = (reference measure/LYNG measure)/Reference
timeFrame: 60 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Ålesund
country: Norway
facility: Helse Møre og Romsdal HF - Aalesund Sjukehus
Study officials:
affiliation: HMR Aalesund Hospital
name: Dag A Lihaug Hoff
role: PRINCIPAL_INVESTIGATOR
References: