LYNG21: Ably LYNG Clinical Demonstration in Operative Environment

NCT05117606 | Unknown DMC

• 1 other identifier: LYNG21_AALESUND
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Monitoring, Physiologic

Keywords

non-intrusive monitoring

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

Vitalsigns

OTHER

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

Interventions

LYNG by Ably Medical DEVICE

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

Vitalsigns

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For patients:
• Admitted to hospital,
• Able to provide voluntary, informed consent.

You may not qualify if:

• 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'

Sponsors & Collaborators

• Ably Medical AS: lead
• Alesund Hospital: collaborator

Study Sites (1)

Helse Møre og Romsdal HF - Aalesund Sjukehus

Ålesund, 6026, Norway

Location

Study Officials

• Dag A Lihaug Hoff

  HMR Aalesund Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 14, 2021
• First Posted: November 11, 2021
• Study Start: May 25, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 31, 2021
• Last Updated: November 11, 2021

Record last verified: 2021-10

Locations

NO (1)