Набор скоро начнётся NCT06035107

Contactless Radar Blood Pressure Validation

— Наблюдательное Blood Pressure

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Radar blood pressure device.
Кому может быть актуально: Состояния в реестре: Blood Pressure. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Великобритания
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Clinical Validation of Contactless Radar Blood Pressure Device

Обзор

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

Подробное описание

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.

Вмешательства

Диагностический тест Radar blood pressure device
The radar blood pressure device will be compared with other traditional blood pressure measurement methods.

Первичные конечные точки

Radar blood pressure compared with blood pressure measured by manual auscultation [Срок оценки: 3 years]

Вторичные конечные точки (1)

Radar blood pressure compared with blood pressure measured invasively [Срок оценки: 3 years]

Критерии участия

Критерии включения

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

Критерии исключения

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: