Automated Measurement of Blood Pressure in Waiting Room (AMBP-waiting) (AMBP-waiting)
Automated Measurement of Blood Pressure in Waiting Appointment Versus 24-h Ambulatory Measurements
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The objective in the care of the hypertensive patient must be to establish a correct diagnosis and obtain a correct control of the BP, with the ultimate aim of reducing cardiovascular morbidity and mortality. Classically, a degree of knowledge of 50% of the hypertensive population has been considered; 50% of these received treatment, and 50% of the latter were controlled, which means a control of 25% of known hypertensive patients. The causes that lead to this deficit control are varied: Low degree of treatment completion, therapeutic inertia - static therapeutic attitude to the poorly controlled patient - and the incorrect measurement of blood pressure values. Therefore, within the control measures to control hypertension, an effort should be made to improve blood pressure measurement techniques. Accurate knowledge of blood pressure (BP) figures is critical for diagnosis, prognosis and therapeutic decision. However, despite the magnitude of the problem and the huge amount of clinical studies, physicians continue to need an optimal technique that can be applied in daily practice. Even in the main population-based studies, such as NHANES, they compared the control of BP with different measurement methods. More recently, the method applied in the SPRINT study has raised great controversy. This technique consists in the measurement of automatic BP in office without the presence of health personnel(ABPM-office), largely avoiding the white coat effect. Their results have influenced the change in the diagnostic figures of hypertension and therapeutic objectives in the recommendations of the American and European guidelines.
This new method was recommended by some scientific societies and in the future could become a reference technique for measuring BP in appointment. A has been shown to obtain readings similar to those of 24h-ABPM and its clinical utility has been demonstrated in a large randomized clinical trial, CAMBO. This method was used in the SPRINT study and some scientific societies have proposed it for the diagnosis of hypertension and recommending it if we do not have 24h-ABPM or it is necessary to perform repeated assessments of BP. The Canadian Society of Hypertension has officially recommended its use and the technique is regularly used by more than 50% of primary care physicians. Despite the positive results, both in US and Europe, this technique has drawbacks that limit its generalization in real-life. The setting of commercial devices are limited and their are compact, table-top device that does not allow patient mobilization. Finally, examination should be performed with the patient alone, in a quiet place and close to the consultation that is rarely available in many health systems.
Therefore,availability of an easy-to-use, portable BP device, which allows BP measured automatically while the patient waits in the medical consultation room, could avoid the white coat effect by providing a accurate BP measurement and avoid a large number of studies.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: JUAN F SANCHEZ MUÑOZ-TORRERO, Ph D
- Phone Number: 0034656259939
- Email: juanf.sanchezm@gmail.com
Study Contact Backup
- Name: JONHATAN GOMEZ RAJA, Dr
- Phone Number: 0034620962640
- Email: jonathan.gomez@fundesalud.es
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Group 1: Patients with clinical indication to perform 24-h BP measurement study due to hypertension diagnostic
Group 2: Patients with clinical indication to perform 24-h BP measurement study due to hypertension control
Description
Inclusion Criteria:
- Indication for 24-h holter pressure study for hypertension diagnosis.
- Indication for 24-h holter pressure study for assess hypertension control
Exclusion Criteria:
- Any inability to perform 24-h ambulatory BP measurements.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Hypertension Diagnosis
Subject need 24-h BP monitor for hypertension diagnosis
|
Automatic Blood pressure measurement with QMon-20 device in the waiting room for 20 minutes every 5 minutes.
Other Names:
|
|
hypertension control evaluation
Patients need 24-h BP monitor for assessment hypertension control
|
Automatic Blood pressure measurement with QMon-20 device in the waiting room for 20 minutes every 5 minutes.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
concordance of systolic and diastolic BP mean between waiting room measurements and 24-h monitor mean.
Time Frame: 6 MONTHS
|
mm Hg differences between measurements in the office with 24-h monitor
|
6 MONTHS
|
|
concordance of systolic and diastolic BP mean between waiting room measurements and 24-h diurnal monitor mean.
Time Frame: 6 MONTHS
|
mm Hg differences between measurements in the office with 24-h monitor
|
6 MONTHS
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: JUAN F SANCHEZ M-TORRERO, PhD, Universidad Extremadura
Publications and helpful links
General Publications
- Robles NR, Sanchez Munoz-Torrero JF. Automated blood pressure measurement in consultation. Med Clin (Barc). 2020 Jan 24;154(2):59-60. doi: 10.1016/j.medcli.2019.04.009. Epub 2019 Jun 11. No abstract available. English, Spanish.
- Rico-Martin S, Sanchez-Bacaicoa M, Calderon-Garcia JF, Labrador-Gomez PJ, De Nicolas Jimenez JM, Villa-Rincon J, Robles NR, Guijarro C, Iammarino C, Rodilla-Salas E, Sanchez Munoz-Torrero JF. Validation of the QMon-20 oscillometric blood pressure monitor for professional office use in the general population according to the ANSI/ESH/ISO 81060-2:2018 protocol. Blood Press Monit. 2021 Oct 1;26(5):393-395. doi: 10.1097/MBP.0000000000000540.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DTS19/00003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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