NCT05661019

Clinical Feasibility of the Myotrace Measurement

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 56 (actual)
• Sponsor: Philips Clinical & Medical Affairs Global · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the feasibility of the MYOTRACE NRD (Neural Respiratory Drive) index as an aid to assess the respiratory status of a patient (improving or stable versus deteriorating) as compared to a specialist in thoracic medicine's evaluation in a general care setting.

Detailed description

This clinical investigation is designed as a single-arm evaluation of a diseased patient population. This study includes a longitudinal observation study of patients who enter the general ward (admission) until they leave the hospital (discharge). This study includes standard patient care by the hospital staff with addition of Myotrace measurement, accelerometry and respiratory rate measurement via respiration belt during the NRD measurement. The primary endpoint of the study is the Neural Respiratory Drive (NRD) index. This index will offline be compared to the specialist in thoracic medicine's assessment of the patient's health status after study closure. The General Ward care team will be blinded to the index values during the study. Re-admission information (i.e. 14 days after discharge) will be collected as well and used in the comparison with NRD index and specialist in thoracic medicine evaluation. Furthermore, the site will be asked to make note of patient events during study participation that are important for the study and study measurements. The secondary endpoints of the study are the spot-check measurements, other objective and subjective measurements, and the subjective evaluation (e.g. experiences, preferences, acceptance, etc) of the Myotrace measurement protocol/procedures by the healthcare professionals and patients. In total 50-60 patients will be enrolled.

Conditions

• Respiratory Disease

Interventions

Type	Name	Description
OTHER	Obtain Myotrace measurements	Myotrace measurement equipment, consisting of an application (i.e. non-medical software) running on a Philips laptop, Porti7 data acquisition system and software (Twente Medical Systems International (TMSi), Netherlands) (CE-approved), ECG cables, and three standard ECG (for EMG) electrodes. Also an on the shelf accelerometry sensor and respiration belt (TMSi) are used for the NRD measurement (CE-approved).

Timeline

• Start date: 2024-05-15
• Primary completion: 2025-01-09
• Completion: 2025-01-09
• First posted: 2022-12-22
• Last updated: 2025-12-09

Locations

1 site across 1 country: Switzerland