LYNG21: Ably LYNG Clinical Demonstration in Operative Environment

Monitoring, Physiologic Clinical Trial

— LYNG21  

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.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05117606
• Other study ID #: LYNG21_AALESUND
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 25, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: October 2021
• Source: Ably Medical AS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Monitoring, Physiologic

Intervention

Device:
• LYNG by Ably Medical
Comparing LYNG to traditional, standard equipment for heart rate, respiration, movement, and blood pressure.

Locations

Country	Name	City	State
Norway	Helse Møre og Romsdal HF - Aalesund Sjukehus	Ålesund

Sponsors (2)

Lead Sponsor	Collaborator
Ably Medical AS	Alesund Hospital

Country where clinical trial is conducted

Norway, 

Outcome

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