NCT05117606

LYNG21: Ably LYNG Clinical Demonstration in Operative Environment

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Ably Medical AS · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	LYNG by Ably Medical	Comparing LYNG to traditional, standard equipment for heart rate, respiration, movement, and blood pressure.

Timeline

• Start date: 2021-05-25
• Primary completion: 2021-12-01
• Completion: 2021-12-31
• First posted: 2021-11-11
• Last updated: 2021-11-11

Locations

1 site across 1 country: Norway