Validation of Respiratory Rate and Heart Rate Measurements by Capaciflectors Placed in Four Locations on the Chest

December 11, 2019 updated by: University Hospital Southampton NHS Foundation Trust

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Southampton, United Kingdom, SO50 9BB
        • University Hospital Southampton NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adults undergoing routine clinical cardiopulmonary exercise testing (CPET).

Description

Inclusion Criteria:

  • Aged 18 and over
  • Able to give informed consent in English
  • Able to at least start a CPET test

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Capaciflector monitoring group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Respiratory rate comparison
Time Frame: Through study completion, an average of one year
Statistical comparisons between the two methods of measuring respiratory rate
Through study completion, an average of one year
Heart rate comparison
Time Frame: Through study completion, an average of one year
Statistical comparisons between the two methods of measuring heart rate
Through study completion, an average of one year
Capaciflector location comparison
Time Frame: Through study completion, an average of one year
Statistical comparisons between the four anatomical chest locations of our capaciflectors
Through study completion, an average of one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Southampton NHS Foundation Trust

Collaborators

University of Southampton

Investigators

  • Study Director: Neil White, PhD, University of Southampton

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2019

Primary Completion (Actual)

October 28, 2019

Study Completion (Actual)

October 28, 2019

Study Registration Dates

First Submitted

October 23, 2018

First Submitted That Met QC Criteria

February 5, 2019

First Posted (Actual)

February 6, 2019

Study Record Updates

Last Update Posted (Actual)

December 12, 2019

Last Update Submitted That Met QC Criteria

December 11, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • RHM CRI0371

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Exercise

Clinical Trials on Capaciflector monitoring

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ecuador

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe