Clinical Feasibility of the Myotrace Measurement

NCT05661019 | Completed

• 1 other identifier: SEF-2023-300047 Myotrace
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Respiratory Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Added value of NRD index

  Mar 2024 (anticipated to be know at end of study)

• 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

  Mar 2024 (anticipated)

Interventions

Obtain Myotrace measurements OTHER

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).

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Philips Clinical & Medical Affairs Global: lead
• Philips Medizin Systeme: collaborator

Study Sites (1)

University Hospital Zürich

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Respiration Disorders

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

• Dr. Schwarz

  University of Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2022
• First Posted: December 22, 2022
• Study Start: May 15, 2024
• Primary Completion: January 9, 2025
• Study Completion: January 9, 2025
• Last Updated: December 9, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)