Myotrace V1.0
Research type
Research Study
Full title
Clinical Feasibility of the Myotrace Measurement
IRAS ID
301931
Contact name
Christian P Subbe
Contact email
Sponsor organisation
Philips Eindhoven
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
In this clinical investigation, we would like to investigate the clinical feasibility of the Myotrace measurement.
Neural Respiratory Drive (NRD) is a signal that the brain outputs to the inspiratory muscles in order to generate sufficient force to breathe.
A surrogate of the NRD, the respiratory muscle effort, can be measured by means of EMG (ElectroMyoGraphy) on the upper chest of a patient. Based on this EMG data, an NRD index can be calculated. A change in the NRD index relates to the change in respiratory drive, and, thus, might inform about the respiratory status of the patient (e.g. screening for dyspnea).
In this study, we would like to investigate if this measure of respiratory effort (or work of breathing) can detect a stable respiratory condition, stabilizing and increasing respiration versus deterioration in patients, as compared to a patient health evaluation done by specialist in Thoracic Medicine on the GW (General Ward; i.e. based on spot-check measurements and other objective and subjective measures). Second, we would like to investigate the measure’s added value on the patient health assessment, as compared to the daily spot-check measurements (e.g oxygen saturation (SpO2), breathing rate, non-invasive blood pressure, heart rate, level of consciousness, and temperature, etc.).
With our current set-up (a laptop with Myotrace software, three standard electrocardiography (ECG) electrodes, an accelerometry sensor, respiration belt, and an off the shelf data acquisition system) we would like to prospectively monitor the respiratory muscle effort in 50 adult patients with a respiratory disease or condition.
Included patients will receive spot-check measurements twice a day, including our Myotrace measurement. Two specialists in thoracic medicine will daily assess and document the patient’s health status. The NRD index will be compared to the specialist in thoracic medicine’s opinion, to 14-day re-admission information, and to other objective and subjective measurement.REC name
Wales REC 5
REC reference
21/WA/0324
Date of REC Opinion
28 Oct 2021
REC opinion
Favourable Opinion