Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Philips Medizin Systeme | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Obtain Myotrace measurements | Other | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Assess the viability of the MYOTRACE measurement protocol within the spot check practice |
Not provided
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)
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
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Dr. Schwarz | University of Zurich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Zürich | Zurich | 8091 | Switzerland |
All data will stay within Philips. A publication might occur with de-identified patient data.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Assess the viability of the MYOTRACE measurement protocol within the spot check practice |
| Mar 2024 (anticipated to be know at end of study) |
| Healthcare/patient satisfaction | Level of healthcare professional as well as patient satisfaction, as captured via semi-quantitative and qualitative survey | Mar 2024 (anticipated) |