Clinical trial NCT05661019: Clinical Feasibility of the Myotrace Measurement
Official title: Clinical Feasibility of the Myotrace Measurement
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Respiratory Disease
Lead sponsor: Philips Clinical & Medical Affairs Global
Sponsor class: INDUSTRY
Collaborators: name: Philips Medizin Systeme
First posted: 2022-12-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Detailed 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.

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

Primary outcomes:
measure: Evaluate Feasibility of the MYOTRACE NRD index
timeFrame: Mar 2024 (anticipated to be know at end of study)
Secondary outcomes:
measure: Added value of NRD index
timeFrame: Mar 2024 (anticipated to be know at end of study)
measure: Assess the viability of the MYOTRACE measurement protocol within the spot check practice
timeFrame: Mar 2024 (anticipated to be know at end of study)
measure: Healthcare/patient satisfaction
timeFrame: Mar 2024 (anticipated)
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: University Hospital Zürich
Study officials:
affiliation: University of Zurich
name: Dr. Schwarz
role: PRINCIPAL_INVESTIGATOR
References: