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
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:
1. To test the reliability and accuracy of our capaciflector in measuring respiratory rate
and heart rate by comparing it with gold standard readings.
2. 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.
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