Contactless Radar Blood Pressure Validation

Blood Pressure Clinical Trial

Official title:

Clinical Validation of Contactless Radar Blood Pressure Device

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06035107
• Other study ID #: 160695
• Secondary ID: IRAS ID: 328944
• Status: Not yet recruiting
• Start date: October 1, 2023
• Est. completion date: October 1, 2026

Study information

• Verified date: September 2023
• Source: University College, London
• Contact: Debbie Falconer, MBBS
• Phone: 07984548291
• Email: debbie.falconer[@]nhs.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal of this observational study is to learn how accurately blood pressure can be measured using a contactless radar device.

The main questions the study aims to answer are:

1. how does blood pressure measured using radar compare with blood pressure using a cuff in patients with known high blood pressure?

2. how does blood pressure measured using radar compare with invasive blood pressure during a coronary angiogram?

3. can the radar blood pressure machine be used to measure blood pressuring during an MRI scan of the heart?

4. can the radar blood pressure machine be used to measure blood pressure during exercise?

Participants in this study will have the following tests:

Group 1: blood pressure measured with the radar device and a cuff when resting Group 2: blood pressure measured with the radar device and by placing a small tube inside the arteries of the wrist (during a clinical procedure) Group 3: blood pressure measured with the radar device and a cuff during a cardiac MRI scan Group 4: blood pressure measured with the radar device and a cuff during exercise

Description:

High blood pressure is the biggest risk factor for heart attacks and strokes. There are several machines available for measuring blood pressure, but most of them need to contact the skin causing discomfort from the inflatable cuff or risking the transmission of infections from reusing cuffs. There are also situations where the cuff machines are inaccurate, such as in older people or during exercise. Therefore, the investigators are trying to develop an accurate contactless system for measuring blood pressure.

The investigators have used advanced but safe radar to create a small machine with a camera that can measure blood pressure from a distance without the need to contact the participant's skin anywhere. It works by detecting tiny movements and changes on the skin produced from the heartbeat and pulse that cannot be seen with the human eye. The investigators want to study how accurate our radar blood pressure machine is by comparing it to other traditional methods of measuring blood pressure.

Firstly, radar blood pressure will be compared to auscultatory blood pressure (a blood pressure system using a cuff) in a group of 25 participants at rest attending a specialist blood pressure clinic. This is currently the internationally recommended method for validating new blood pressure devices.

Then radar blood pressure will be compared with invasive blood pressure (measured inside the arteries by a small tube) in 50 participants undergoing clinically-indicated cardiac catheterisation at the Royal Free Hospital.

Next a radar device capable of measuring blood pressure in participants lying inside the cardiovascular magnetic resonance (CMR) scanner will be developed. The radar blood pressure derived in the CMR scanner will be compared to oscillometric blood pressure in 25 participants (a cuff-based BP system that is currently used in patients being scanned). Finally, radar-BP will be compared with oscillometric BP in 50 participants during exercise including sit-to-stand movements and using a bike ergometer.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: October 1, 2026
• Est. primary completion date: October 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Group 1:

• Age > 18 years old

• under the care of the complex hypertension clinic

• able to take auscultatory blood pressure from right arm

Group 2:

• Age >18

• has been selected to undergo invasive coronary angiogram by a consultant cardiologist

Group 3:

• Age >18

• willing to undergo a cardiac MRI scan

Group 4:

• Age > 18

Exclusion Criteria:

Group 1

• anyone unable to consent

• inaudible Korotkoff K1/K5 sounds

• systolic BP difference >12 mmHg and/or diastolic >8 mmHg in any of the auscultatory measurements during the validation study

• contraindication to cuff-based BP measurement e.g. lymph node clearance on right side

Group 2:

• anyone unable to consent

• anyone in whom right radial arterial access cannot be obtained (e.g. severe skin abnormality such as scleroderma)

• known arterio-venous malformation or fistulas in right arm

• any contraindication to an invasive angiogram such as severe frailty

Group 3:

• anyone unable to consent

• anyone with a classical contraindication to an MRI study such as known metal fragments allergy to used contrast

• high degree heart block

• asthma

Group 4:

• anyone unable to consent

• anyone with exertional chest pain or known uncontrolled angina

• anyone with a known positive cardiac stress test.

Related Conditions & MeSH terms

• Blood Pressure

Intervention

Diagnostic Test:
• Radar blood pressure device
The radar blood pressure device will be compared with other traditional blood pressure measurement methods.

Locations

Country	Name	City	State
United Kingdom	UCL Bloomsbury Centre for Clinical Phenotyping	London

Sponsors (1)

Lead Sponsor	Collaborator
University College, London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Radar blood pressure compared with oscillometric blood pressure during a cardiac MRI scan	To compare the radar BP measurements with readings from an oscillometric cuff during a cardiac MR scan	3 years
Other	Radar blood pressure compared with oscillometric blood pressure during exercise	To compare the radar BP measurements with readings from an oscillometric cuff during exercise.	3 years
Primary	Radar blood pressure compared with blood pressure measured by manual auscultation	To determine if the radar module can derive accurate blood pressure measurements when compared against non-invasive blood pressure measurements by manual auscultation in a group of participants with known hypertension.	3 years
Secondary	Radar blood pressure compared with blood pressure measured invasively	To compare the blood pressure measurements from the radar BP device with invasive blood pressure measurements obtained at the time of coronary angiography	3 years