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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03832205
• Other study ID #: RHM CRI0371
• Status: Completed
• Start date: September 30, 2019
• Est. completion date: October 28, 2019

Study information

• Verified date: December 2019
• Source: University Hospital Southampton NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 28, 2019
• Est. primary completion date: October 28, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Exercise
• Heart Rate
• Respiratory Rate

Intervention

Device:
• Capaciflector monitoring
Non-invasive capaciflector monitoring of respiratory rate and heart rate.

Locations

Country	Name	City	State
United Kingdom	University Hospital Southampton NHS Foundation Trust	Southampton

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Southampton NHS Foundation Trust	University of Southampton

Country where clinical trial is conducted

United Kingdom, 

References & Publications (4)

Effects 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

Gerry 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. — View Citation

Naranjo-Hernández D, Talaminos-Barroso A, Reina-Tosina J, Roa LM, Barbarov-Rostan G, Cejudo-Ramos P, Márquez-Martín 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). pii: E2144. doi: 10.3390/s18072144. — View Citation

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

Outcome

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