Evaluating the Myotrace Measurement for Respiratory Status Assessment
Clinical Feasibility of the Myotrace Measurement
Philips Clinical & Medical Affairs Global · NCT05661019
This study is testing if a new tool called Myotrace can help doctors better understand the breathing status of patients in the hospital.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Philips Clinical & Medical Affairs Global (industry) |
| Locations | 1 site (Zürich) |
| Trial ID | NCT05661019 on ClinicalTrials.gov |
What this trial studies
This clinical investigation aims to assess the feasibility of the Myotrace Neural Respiratory Drive (NRD) index in evaluating the respiratory status of patients in a general care setting. The study will involve a longitudinal observation of patients admitted to the hospital, where standard care will be supplemented with Myotrace measurements, accelerometry, and respiratory rate monitoring. The primary endpoint is to compare the NRD index with evaluations made by a specialist in thoracic medicine after the study concludes. Additionally, the study will collect data on patient readmissions and subjective experiences related to the Myotrace measurement protocol. A total of 50-60 patients will be enrolled in this single-arm study.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with specific respiratory conditions such as COPD exacerbations, asthma exacerbations, or interstitial lung diseases.
Not a fit: Patients without obstructive or restrictive respiratory disorders or those who do not speak English or German may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a reliable tool for assessing respiratory status, potentially improving patient management and outcomes.
How similar studies have performed: While the Myotrace measurement approach is novel, similar studies assessing respiratory status using objective indices have shown promise in the past.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Zürich
- University Hospital Zürich — Zürich, Switzerland (RECRUITING)
Study contacts
- Principal investigator: Dr. Schwarz — University of Zurich
- Study coordinator: Weichert
- Email: jochen.weichert@philips.com
- Phone: +31 648656901
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Respiratory Disease