Validation of Respiratory Rate and Heart Rate Measurements by Capaciflectors Placed in Four Locations on the Chest
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
1 other identifier
observational
50
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2019
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 23, 2018
CompletedFirst Posted
Study publicly available on registry
February 6, 2019
CompletedStudy Start
First participant enrolled
September 30, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 28, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 28, 2019
CompletedDecember 12, 2019
December 1, 2019
28 days
October 23, 2018
December 11, 2019
Conditions
Outcome Measures
Primary Outcomes (3)
Respiratory rate comparison
Statistical comparisons between the two methods of measuring respiratory rate
Through study completion, an average of one year
Heart rate comparison
Statistical comparisons between the two methods of measuring heart rate
Through study completion, an average of one year
Capaciflector location comparison
Statistical comparisons between the four anatomical chest locations of our capaciflectors
Through study completion, an average of one year
Study Arms (1)
Capaciflector monitoring group
Patients undergoing their pre-planned, routine cardiopulmonary exercise test (CPET). Additional, non-invasive capaciflector monitoring only - no therapeutic intervention.
Interventions
Non-invasive capaciflector monitoring of respiratory rate and heart rate.
Eligibility Criteria
Adults undergoing routine clinical cardiopulmonary exercise testing (CPET).
You may qualify if:
- Aged 18 and over
- Able to give informed consent in English
- Able to at least start a CPET test
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Southampton NHS Foundation Trust
Southampton, SO50 9BB, United Kingdom
Related Publications (5)
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
BACKGROUNDNaranjo-Hernandez D, Talaminos-Barroso A, Reina-Tosina J, Roa LM, Barbarov-Rostan G, Cejudo-Ramos P, Marquez-Martin 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):2144. doi: 10.3390/s18072144.
PMID: 29970861BACKGROUNDGerry 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.
PMID: 29203508BACKGROUNDEffects 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
BACKGROUNDHayward N, Shaban M, Badger J, Jones I, Wei Y, Spencer D, Isichei S, Knight M, Otto J, Rayat G, Levett D, Grocott M, Akerman H, White N. A capaciflector provides continuous and accurate respiratory rate monitoring for patients at rest and during exercise. J Clin Monit Comput. 2022 Oct;36(5):1535-1546. doi: 10.1007/s10877-021-00798-7. Epub 2022 Jan 18.
PMID: 35040037DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Neil White, PhD
University of Southampton
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 23, 2018
First Posted
February 6, 2019
Study Start
September 30, 2019
Primary Completion
October 28, 2019
Study Completion
October 28, 2019
Last Updated
December 12, 2019
Record last verified: 2019-12