Clinical Feasibility of the Myotrace Measurement

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Disease
• Intervention / Treatment: Other: Obtain Myotrace measurements

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.

• Study Type: Observational
• Enrollment (Actual): 56

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland, 8091
    • University Hospital Zurich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

During recruitment of the patients, all patients admitted to the general ward who are having a respiratory disease or condition and satisfy the inclusion criteria will be eligible, including patients returning to general ward from ICU admission.

Description

Inclusion Criteria:

• Age 18+, fluent knowledge of English or German.

• Group A: Obstructive ventilatory disorders (conditions resulting in an increased load on the respiratory muscle pump due to hyperinflation ± pronounced hypoxaemia)

  • Acute exacerbation of COPD (pronounced hypoxia OR acute or acute on chronic hypercapnic respiratory failure)
  • Exacerbation of asthma bronchiale
  • Exacerbation of non-CF-bronchiectasis (infectious)
  • Infectious exacerbation of lung disease in cystic fibrosis

• Group B: Conditions with an increase in NRD due to an impairment in gas exchange (particularly die to diffusion limitation and/or ventilation-perfusion-mismatch

  • Exacerbation of an interstitial lung disease (e.g. Idiopathic pulmonary fibrosis (IPF), Non Specific Interstitial Pneumonia (NSIP), Connective tissue disease- associated interstitial lung disease CTD-ILD)
  • Worsening of pulmonary arterial hypertension World Health Organisation (WHO) group 1 (e.g. due decompensated heart failure)
  • Acute pulmonary embolism
  • Pneumonia (resulting in hypoxaemia)

Exclusion Criteria:

• Obesity hypoventilation syndrome (rationale: NRD decreased)
• Obesity WHO III with Body Mass Index (BMI) > 40 kg/m2 (rationale: surface EMG signal quality low)
• Hypercapnic respiratory failure due to hypoventilation of central origin, e.g. opiate-induced, Congenital central hypoventilation syndrome, post stroke (rationale: central respiratory control affected)
• Neuromuscular disease affecting respiratory muscles, e.g. motor neurone disease, muscular dystrophy type Duchenne etc. (rationale: EMG signal quality etc. different)
• Decompensated heart failure with atrial fibrillation (rationale: central breathing disturbance common)
• Patients on chronic opioid therapy (e.g. chronic pain, methadone etc.) (rationale: reduced NRD)
• Self reported pregnancy

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate Feasibility of the MYOTRACE NRD index	to evaluate the feasibility of the MYOTRACE NRD index as an aid to assess the respiratory status of a patient as compared to a specialist in thoracic medicine's evaluation in a general care setting.	Mar 2024 (anticipated to be know at end of study)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Added value of NRD index	Investigate the added value of the NRD index on patient assessment, in comparison to the other spot-check measures	Mar 2024 (anticipated to be know at end of study)
Assess the viability of the MYOTRACE measurement protocol within the spot check practice	Assess the viability of the MYOTRACE measurement protocol within the spot check practice	Mar 2024 (anticipated to be know at end of study)
Healthcare/patient satisfaction	Level of healthcare professional as well as patient satisfaction, as captured via semi-quantitative and qualitative survey	Mar 2024 (anticipated)

Collaborators and Investigators

• Sponsor: Philips Clinical & Medical Affairs Global
• Collaborators: Philips Medizin Systeme
• Investigators: Principal Investigator: Dr. Schwarz, University of Zurich

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2024
• Primary Completion (Actual): January 9, 2025
• Study Completion (Actual): January 9, 2025

Study Registration Dates

• First Submitted: December 13, 2022
• First Submitted That Met QC Criteria: December 13, 2022
• First Posted (Actual): December 22, 2022

Study Record Updates

• Last Update Posted (Estimated): December 9, 2025
• Last Update Submitted That Met QC Criteria: December 2, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders
• Other Study ID Numbers: SEF-2023-300047 Myotrace

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: All data will stay within Philips. A publication might occur with de-identified patient data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No