ExerciseNCT03832205
Validation of Respiratory Rate and Heart Rate Measurements by Capaciflectors Placed in Four Locations on the Chest
An observational study of Exercise and Respiratory Rate, run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise, Respiratory Rate, Heart Rate
- What is being tested?
- Capaciflector monitoring
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Sep 2019to 28 Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults undergoing routine clinical cardiopulmonary exercise testing (CPET).
Who may be able to join
- Aged 18 and over
- Able to give informed consent in English
- Able to at least start a CPET test
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospital Southampton NHS Foundation Trust
Southampton, SO50 9BB
About this study
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
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.
Read the detailed description
RESEARCH QUESTION/AIM(S)
Will a capaciflector measure the respiratory rate as accurately as a pneumotachometer and the heart rate as accurately as an electrocardiogram?
Objectives:
- To test the reliability and accuracy of our capaciflector in measuring respiratory rate and heart rate by comparing it with gold standard readings.
- To assess whether different capaciflector locations around the body are all as accurate as each other.
STUDY DESIGN and METHODS of DATA COLLECTION AND DATA ANALYSIS
Unblinded observational study - for each subject demographic data will be collected: age, gender, height, weight, body mass index.
As well as the routine monitoring devices worn while undergoing a CPET test, the patients will have 4 capaciflectors placed on them as well. These will be placed using hypoallergenic medical grade tape.
- Over the left precordium
- Over the right precordium
- Under the left axilla
- Under the right axilla
Each practical component of the study setup will be delivered consistently by CI Dr Nick Hayward, Student Doctor Alan Doughty, or cardiopulmonary exercise testing (CPET) technicians once the study becomes established. The patient will then undergo a routine CPET and our monitors will not affect what a patient is asked to do as part of the current CPET protocol. If a patient is unable to finish the CPET then their data will still be included.
Raw CPET data will be exported via a feed from the CPET machine and also from the capaciflectors. A laptop computer provided by the University will receive both data feeds. Simultaneous recordings will be taken from each of the capaciflectors at time zero and then at one minute intervals. These anonymous datasets will be stored on the laptop computer. Once the CPET test is completed, the participant's involvement in the study will have ended.
Anonymised raw data analysis comparisons will be made by the Department of Engineering, University of Southampton, in collaboration with the other investigators of this study. There will be no patient identifiable information in any dataset, yet demographic data and raw CPET acquired data will be held securely on the laptop in line with clinical governance requirements of University Hospital Southampton. Statistical support by Dr Helen Moyses of the Clinical Informatics Research Unit, Southampton, will be provided for data analysis at the final stage.
STUDY SETTING
The study will be a single centre study at University Hospital Southampton. Participants will have been recruited from the patients booked for a CPET test prior to them having major surgery. The study will be conducted in the CPET department in the Day Surgery Unit. This is where the CPET for patients routinely takes place.
- Conditions
- Exercise, Respiratory Rate, Heart Rate
- Being tested
- Capaciflector monitoring
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capaciflector monitoringDevice
Non-invasive capaciflector monitoring of respiratory rate and heart rate.
| Study group | Role | What they receive |
|---|---|---|
| Capaciflector monitoring group | Patients undergoing their pre-planned, routine cardiopulmonary exercise test (CPET). Additional, non-invasive capaciflector monitoring only - no therapeutic intervention. Receives: Device: Capaciflector monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory rate comparison
Statistical comparisons between the two methods of measuring respiratory rate
Measured: Through study completion, an average of one year
Heart rate comparison
Statistical comparisons between the two methods of measuring heart rate
Measured: Through study completion, an average of one year
Capaciflector location comparison
Statistical comparisons between the four anatomical chest locations of our capaciflectors
Measured: Through study completion, an average of one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2019
- Study start30 Sep 2019
- Primary completion28 Oct 2019
- Study completion28 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ExerciseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Southampton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southampton
- Responsible party
- Sponsor
- Investigators
- Neil White, PhD, Study director, University of Southampton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03832205
- Sponsor's protocol ID
- RHM CRI0371
- Status last verified
- Dec 2019
- First submitted
- 23 Oct 2018
- Last updated
- 12 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: No personal identifiable data will be shared. Physiological data may be shared with statisticians within the University or University Hospital. Data analysis may be partly conducted by Dr Peter Charlton, Kings College London, UK
Publications
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
Naranjo-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.
PubMed 29970861Gerry 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.
PubMed 29203508Effects 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
Hayward 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.
PubMed 35040037
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03832205
- Acronym / sponsor ID
- RHM CRI0371
- Conditions
- Exercise, Respiratory Rate, Heart Rate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital Southampton NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Southampton
- Study start
- 30 Sep 2019 (actual)
- Primary completion
- 28 Oct 2019 (actual)
- Study completion
- 28 Oct 2019 (actual)
- First posted
- 6 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
RESEARCH QUESTION/AIM(S)
Will a capaciflector measure the respiratory rate as accurately as a pneumotachometer and the heart rate as accurately as an electrocardiogram?
Objectives:
- To test the reliability and accuracy of our capaciflector in measuring respiratory rate and heart rate by comparing it with gold standard readings.
- To assess whether different capaciflector locations around the body are all as accurate as each other.
STUDY DESIGN and METHODS of DATA COLLECTION AND DATA ANALYSIS
Unblinded observational study - for each subject demographic data will be collected: age, gender, height, weight, body mass index.
As well as the routine monitoring devices worn while undergoing a CPET test, the patients will have 4 capaciflectors placed on them as well. These will be placed using hypoallergenic medical grade tape.
- Over the left precordium
- Over the right precordium
- Under the left axilla
- Under the right axilla
Each practical component of the study setup will be delivered consistently by CI Dr Nick Hayward, Student Doctor Alan Doughty, or cardiopulmonary exercise testing (CPET) technicians once the study becomes established. The patient will then undergo a routine CPET and our monitors will not affect what a patient is asked to do as part of the current CPET protocol. If a patient is unable to finish the CPET then their data will still be included.
Raw CPET data will be exported via a feed from the CPET machine and also from the capaciflectors. A laptop computer provided by the University will receive both data feeds. Simultaneous recordings will be taken from each of the capaciflectors at time zero and then at one minute intervals. These anonymous datasets will be stored on the laptop computer. Once the CPET test is completed, the participant's involvement in the study will have ended.
Anonymised raw data analysis comparisons will be made by the Department of Engineering, University of Southampton, in collaboration with the other investigators of this study. There will be no patient identifiable information in any dataset, yet demographic data and raw CPET acquired data will be held securely on the laptop in line with clinical governance requirements of University Hospital Southampton. Statistical support by Dr Helen Moyses of the Clinical Informatics Research Unit, Southampton, will be provided for data analysis at the final stage.
STUDY SETTING
The study will be a single centre study at University Hospital Southampton. Participants will have been recruited from the patients booked for a CPET test prior to them having major surgery. The study will be conducted in the CPET department in the Day Surgery Unit. This is where the CPET for patients routinely takes place.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Capaciflector monitoring group | – | Device: Capaciflector monitoringPatients undergoing their pre-planned, routine cardiopulmonary exercise test (CPET). Additional, non-invasive capaciflector monitoring only - no therapeutic intervention. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults undergoing routine clinical cardiopulmonary exercise testing (CPET).
Key inclusion criteria (3 listed)
- Aged 18 and over
- Able to give informed consent in English
- Able to at least start a CPET test
Key exclusion criteria (12 listed)
- Absolute contraindications to taking part in CPET:
- Recent (within 5 days) Acute Myocardial Infarction
- Unstable angina
- Uncontrolled arrhythmia causing symptoms or haemodynamic compromise
- Syncope
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Capaciflector monitoringNon-invasive capaciflector monitoring of respiratory rate and heart rate. | Device | Capaciflector monitoring group |
Primary outcome
Respiratory rate comparison
Time frame: Through study completion, an average of one year
Statistical comparisons between the two methods of measuring respiratory rate
Heart rate comparison
Time frame: Through study completion, an average of one year
Statistical comparisons between the two methods of measuring heart rate
Capaciflector location comparison
Time frame: Through study completion, an average of one year
Statistical comparisons between the four anatomical chest locations of our capaciflectors
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2019.
- BackgroundWhite 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
- Background: PubMed 29970861Naranjo-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.
- Background: PubMed 29203508Gerry 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.
- BackgroundEffects 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
- Derived from this study: PubMed 35040037Hayward 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.
- Individual participant dataSharing planned: Undecided. No personal identifiable data will be shared. Physiological data may be shared with statisticians within the University or University Hospital. Data analysis may be partly conducted by Dr Peter Charlton, Kings College London, UK
Related trials for Exercise
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neil White, PhD study director
University of Southampton
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Exercise and Respiratory Rate, run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory rate comparison (time frame: Through study completion, an average of one year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03832205, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2019.