Exercise Clinical Trial
Official title:
Validation of a Capaciflector Against a Pneumotachometer to Measure Respiratory Rate and a Capaciflector Against Electrocardiography to Measure Heart Rate at Different Anatomical Chest Locations During Cardiopulmonary Exercise Testing
Verified date | December 2019 |
Source | University Hospital Southampton NHS Foundation Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
In a collaborative project between University Hospital Southampton NHS Trust and the
University of Southampton, the investigators have developed a wearable, mobile, non invasive,
low-cost, continuous respiratory rate monitor device called a capaciflector.
This study will be the first ever study undertaken to attempt to measure the respiratory rate
and heart rate on patients using a capaciflector. Investigators will evaluate whether the
correlation between the capaciflector's measurements of respiratory rate and heart rate when
compared with the gold standard pneumotachometer and electrocardiogram respectively is high
enough to promote its potential future use within a device for clinical practice.
Status | Completed |
Enrollment | 50 |
Est. completion date | October 28, 2019 |
Est. primary completion date | October 28, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility |
Inclusion Criteria: - Aged 18 and over - Able to give informed consent in English - Able to at least start a CPET test Exclusion Criteria: - Absolute contraindications to taking part in CPET: - Recent (within 5 days) Acute Myocardial Infarction - Unstable angina - Uncontrolled arrhythmia causing symptoms or haemodynamic compromise - Syncope - Active endocarditis, acute myocarditis or pericarditis - Symptomatic severe aortic stenosis - Uncontrolled heart failure - Suspected dissecting or leaking aortic aneurysm - Uncontrolled asthma - Arterial desaturation at rest on room air < 85% - Known allergy to medical grade tape |
Country | Name | City | State |
---|---|---|---|
United Kingdom | University Hospital Southampton NHS Foundation Trust | Southampton |
Lead Sponsor | Collaborator |
---|---|
University Hospital Southampton NHS Foundation Trust | University of Southampton |
United Kingdom,
Effects of current on human beings and livestock - Part 1: General Aspects, section 4.5.4 (1993) Bureau of Indian Standards, New Delhi. http://questin.org/sites/default/files/standards/is.8437.1.1992_0.pdf
Gerry S, Birks J, Bonnici T, Watkinson PJ, Kirtley S, Collins GS. Early warning scores for detecting deterioration in adult hospital patients: a systematic review protocol. BMJ Open. 2017 Dec 3;7(12):e019268. doi: 10.1136/bmjopen-2017-019268. — View Citation
Naranjo-Hernández D, Talaminos-Barroso A, Reina-Tosina J, Roa LM, Barbarov-Rostan G, Cejudo-Ramos P, Márquez-Martín E, Ortega-Ruiz F. Smart Vest for Respiratory Rate Monitoring of COPD Patients Based on Non-Contact Capacitive Sensing. Sensors (Basel). 2018 Jul 3;18(7). pii: E2144. doi: 10.3390/s18072144. — View Citation
White N. et al. (2017) A Planar Respiration Sensor Based on a Capaciflector Structure. IEEE Sensors Letters vol. 1 no. 4 pp. 1-4 Art no. 6000604. doi: 10.1109/LSENS.2017.2722481. http://ieeexplore.ieee.org/stamp/stamp.jsp?tp=&arnumber=7967772&isnumber=7949374
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Respiratory rate comparison | Statistical comparisons between the two methods of measuring respiratory rate | Through study completion, an average of one year | |
Primary | Heart rate comparison | Statistical comparisons between the two methods of measuring heart rate | Through study completion, an average of one year | |
Primary | Capaciflector location comparison | Statistical comparisons between the four anatomical chest locations of our capaciflectors | Through study completion, an average of one year |
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