Validation of Respiratory Rate and Heart Rate Measurements by Capaciflectors Placed in Four Locations on the Chest
Condition: Exercise; Respiratory Rate; Heart Rate
Study type: Observational

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.
    

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:

        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.
    

Intervention name(s): Capaciflector monitoring
Intervention type(s): Device
Intervention description(s): Non-invasive capaciflector monitoring of respiratory rate and heart rate.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adults undergoing routine clinical cardiopulmonary exercise testing (CPET).