Clinical Feasibility of the Myotrace Measurement

Launched by PHILIPS CLINICAL & MEDICAL AFFAIRS GLOBAL · Dec 13, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to measure how well a person's lungs are working, especially for those with respiratory diseases. The study will use a tool called the MYOTRACE NRD (Neural Respiratory Drive) index to see if it can accurately assess whether a patient's condition is getting better, staying the same, or getting worse, compared to an evaluation done by a lung specialist. The trial is currently recruiting participants aged 18 and older who can speak English or German.

To be eligible to join, participants should have certain respiratory conditions, such as COPD (chronic obstructive pulmonary disease), asthma, or pneumonia. However, some individuals may not qualify, like those with very high obesity, certain neuromuscular diseases, or specific heart issues. If someone decides to participate, they can expect to help researchers understand if this new measurement tool is effective in a general hospital setting, which could improve care for people with respiratory diseases in the future.

Gender

ALL

Eligibility 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

Trial Officials