LYNG21: Ably LYNG Clinical Demonstration in Operative Environment

NCT ID: NCT05117606

Last Updated: 2021-11-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-25
• Study Completion Date: 2021-12-31

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.

Conditions

Monitoring, Physiologic

Keywords

non-intrusive monitoring

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

LYNG by Ably Medical

Intervention Type: DEVICE

Comparing LYNG to traditional, standard equipment for heart rate, respiration, movement, and blood pressure.

Interventions

LYNG by Ably Medical

Comparing LYNG to traditional, standard equipment for heart rate, respiration, movement, and blood pressure.

Intervention Type: DEVICE

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'

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alesund Hospital

OTHER

Sponsor Role: collaborator

Ably Medical AS

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dag A Lihaug Hoff

Role: PRINCIPAL_INVESTIGATOR

HMR Aalesund Hospital

Locations

Helse Møre og Romsdal HF - Aalesund Sjukehus

Ålesund, , Norway

Countries

Norway

Other Identifiers

LYNG21_AALESUND

Identifier Type: -

Identifier Source: org_study_id