An observational study in Exercise, Respiratory Rate and Heart Rate, sponsored by University Hospital Southampton NHS Foundation Trust. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-12-12.
Sponsored by University Hospital Southampton NHS Foundation Trust · 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.
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:
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.
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.
2,646 studies on the registry are indexed under Motor Activity; 1,205 are open to participants now.
This study's enrollment of 50 is below the median of 100 across 318 observational studies indexed under Motor Activity.
Browse Motor Activity studies →University Hospital Southampton NHS Foundation Trust is the lead sponsor of 150 studies on the registry; 35 are open to participants now.
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Adults undergoing routine clinical cardiopulmonary exercise testing (CPET).
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Exclusion Criteria:
Patients undergoing their pre-planned, routine cardiopulmonary exercise test (CPET). Additional, non-invasive capaciflector monitoring only - no therapeutic intervention.
Device: Capaciflector monitoring
Non-invasive capaciflector monitoring of respiratory rate and heart rate.
Respiratory rate comparison
Statistical comparisons between the two methods of measuring respiratory rate
Time frame: Through study completion, an average of one year
Heart rate comparison
Statistical comparisons between the two methods of measuring heart rate
Time frame: Through study completion, an average of one year
Capaciflector location comparison
Statistical comparisons between the four anatomical chest locations of our capaciflectors
Time frame: Through study completion, an average of one year
Plan to share: 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
This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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