Clinical Feasibility of the Myotrace Measurement

Respiratory Disease Clinical Trial

Official title:

Clinical Feasibility of the Myotrace Measurement

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05661019
• Other study ID #: SEF-2023-300047 Myotrace
• Status: Recruiting
• Start date: May 6, 2024
• Est. completion date: December 1, 2024

Study information

• Verified date: May 2024
• Source: Philips Clinical & Medical Affairs Global
• Contact: Weichert
• Phone: +31 648656901
• Email: jochen.weichert[@]philips.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 1, 2024
• Est. primary completion date: October 31, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Respiration Disorders
• Respiratory Disease
• Respiratory Tract Diseases

Intervention

Other:
• Obtain Myotrace measurements
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).

Locations

Country	Name	City	State
Switzerland	University Hospital Zürich	Zürich

Sponsors (2)

Lead Sponsor	Collaborator
Philips Clinical & Medical Affairs Global	Philips Medizin Systeme

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	Healthcare/patient satisfaction	Level of healthcare professional as well as patient satisfaction, as captured via semi-quantitative and qualitative survey	Mar 2024 (anticipated)