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NCT05661019
Clinical Feasibility of the Myotrace Measurement
Conditions: Respiratory Disease
Sex: All
Ages: 18 Years – N/A
Enrollment: 60
Sponsor: Philips Electronics Nederland B.V. acting through Philips CTO organization
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.
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 bronchialeExacerbation of non-CF-bronchiectasis (infectious)Infectious exacerbation of lung disease in cystic fibrosisGroup B: Conditions with an increase in NRD due to an impairment in gas exchange (particularly die to diffusion limitation and/or ventilation-perfusion-mismatchExacerbation 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 embolismPneumonia (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
Source: ClinicalTrials.gov (NCT05661019). StuddyBuddy aggregates publicly available trial information.