Concordance Between Central Blood PRessure dEvices In Nephrology Patients
- Conditions
- Chronic Kidney DiseaseHypertensionBlood Pressure
- Interventions
- Device: Brachial and Central BP measurements with Mobil-o-Graph NG device (IEM), WatchBP Office device (Microlife), BP+ device (Uscom) and Oscar 2 with SphygmoCor inside device (SunTech)
- Registration Number
- NCT05963880
- Lead Sponsor
- Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
- Brief Summary
The most accurate way to determine intra-aortic BP is to obtain invasive measures by vascular catheterization, which is not possible to perform routinely during the regular follow-up of patients. However, in recent years, devices used to estimate central BP have been designed and approved for clinical use. These devices can determine aortic BP in a non-invasive way using various techniques and algorithms and offer a high degree of precision when compared to invasive measurements of intraaortic BP. On the other hand, certain characteristics specific to the different devices mean that the central BP values obtained may not be interchangeable. It is therefore important to determine the degree of agreement of central BP values obtained using commercially available devices.
This study aims to determine the degree of agreement between central BP measurements obtained using 4 devices commonly used to measure central blood pressure, i.e. Mobil-o-Graph NG (IEM, Germany), WatchBP Office (Microlife, Taiwan), Oscar 2 with SphygmoCor inside (SunTech, USA) and BP+ (Uscom, Australia). These four devices record the shape of the pulsatile wave and then derive the central BP using an algorithm. The main differences between these devices lie in this algorithm, or "transfer function,", which is unique to each and the calibration used. All use a brachial cuff to capture the pulse waveform and can easily be used in clinical practice.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 119
- Age 18-80 years old
- Ongoing atrial fibrillation
- Arm circumference incompatible with the blood pressure cuffs for all devices (<18 cm or > 50 cm)
- Incapacity to give consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Hypertension group Brachial and Central BP measurements with Mobil-o-Graph NG device (IEM), WatchBP Office device (Microlife), BP+ device (Uscom) and Oscar 2 with SphygmoCor inside device (SunTech) Patients with BP \> 135/85 mmHg or taking any antihypertensive medication with normal kidney function (eGFR \> 60 ml/min/1.73m2) Advanced CKD group Brachial and Central BP measurements with Mobil-o-Graph NG device (IEM), WatchBP Office device (Microlife), BP+ device (Uscom) and Oscar 2 with SphygmoCor inside device (SunTech) Patients with eGFR \< 30 ml/min/1.73m2 not on dialysis Dialysis groups Brachial and Central BP measurements with Mobil-o-Graph NG device (IEM), WatchBP Office device (Microlife), BP+ device (Uscom) and Oscar 2 with SphygmoCor inside device (SunTech) Patients on hemodialysis or peritoneal dialysis Control group Brachial and Central BP measurements with Mobil-o-Graph NG device (IEM), WatchBP Office device (Microlife), BP+ device (Uscom) and Oscar 2 with SphygmoCor inside device (SunTech) Normotensive patients without any antihypertensive drugs or chronic kidney disease
- Primary Outcome Measures
Name Time Method Central SBP difference at enrollment (time 0) Differences in the central SBP measured by each device
- Secondary Outcome Measures
Name Time Method Brachial SBP difference at enrollment (time 0) Differences in the brachial cuff SBP measured by each device
Brachial DBP difference at enrollment (time 0) Differences in the brachial cuff DBP measured by each device
Central DBP difference at enrollment (time 0) Differences in the central DBP measured by each device
Trial Locations
- Locations (1)
Hôpital du Sacré-Coeur de Montréal
🇨🇦Montréal, Quebec, Canada