LYNG21: Ably LYNG Clinical Demonstration in Operative Environment (LYNG21)

ABLY LYNG Study at Helse More Romsdal - Aalesund Sykehus HMR With the Ably LYNG Patient Care Solution Advanced Prototype by Ably Medical AS.

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Monitoring, Physiologic
• Intervention / Treatment: Device: LYNG by Ably Medical

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Ålesund, Norway, 6026
    • Helse Møre og Romsdal HF - Aalesund Sjukehus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Vitalsigns; 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.	Device: LYNG by Ably Medical; Comparing LYNG to traditional, standard equipment for heart rate, respiration, movement, and blood pressure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Ably Medical AS
• Collaborators: Alesund Hospital
• Investigators: Principal Investigator: Dag A Lihaug Hoff, HMR Aalesund Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2021
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: September 14, 2021
• First Submitted That Met QC Criteria: November 1, 2021
• First Posted (Actual): November 11, 2021

Study Record Updates

• Last Update Posted (Actual): November 11, 2021
• Last Update Submitted That Met QC Criteria: November 1, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: non-intrusive monitoring
• Other Study ID Numbers: LYNG21_AALESUND

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No