Accuracy of Non-invasive Blood Pressure Monitoring at the Wrist in Obese Patients
NCT ID: NCT03640429
Last Updated: 2019-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
40 participants
OBSERVATIONAL
2018-08-21
2019-05-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The aim of this work is to validate the wrist OBP monitor in obese patients and compare it to upper arm location (in accuracy, convenience, and trending) using invasive blood pressure monitor as a reference standard.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Non-invasive Blood Pressure (BP) Monitoring Compared to A-Line BP Monitoring
NCT00739700
Invasive Validation of Non-invasive Central Blood Pressure Measurements Using Oscillometric Pulse Wave Analysis
NCT03046264
Accuracy of Non-invasive Non-oscillometric Blood Pressure Wristband
NCT03629535
Validation of Wrist Type Oscillometric Blood Pressure Monitorings
NCT04633785
Non-invasive Validation of Non-invasive Central Blood Pressure Measurements Using Oscillometric Pulse Wave Analysis
NCT03049709
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The gold standard for ABP measurement is through a catheter placed in an artery. Being an invasive, measurement of BP through an arterial catheter is restricted to patients with rapid major fluid shifts. Many indirect methods are used for measurement of ABP. Oscillometric blood pressure (OBP) monitoring is considered the standard non-invasive monitor for use in most clinical situations. In OBP monitor, a pressure transducer located in the cuff senses the series of small oscillations heart-beat induced pulse volume changes. These oscillations are detected during deflation of the cuff pressure from above the SBP to diastolic blood pressure (DBP).
The upper arm is the standard location of application of the blood pressure cuff as it is aligned with the heart level regardless the patient position. In obese patients, OBP monitoring is considered superior to auscultatory method which is limited by faint auscultatory sounds. However, application of blood pressure cuff at the upper arm in this population is frequently limited by large arm circumference and asymmetrical arm contour. Thus, locating the cuff at the wrist might be a more feasible alternative for the upper arm. OBP monitoring at the wrist was previously compared to auscultatory measurement of ABP in non-surgical patients. A recent study investigated the accuracy of OBP at the upper forearm in obese patients. No data to the best of our knowledge validated OBP monitoring at the lower forearm in obese patients using invasive blood pressure monitor as a reference standard.
The aim of this work is to validate the wrist OBP monitor in obese patients and compare it to upper arm location (in accuracy, convenience, and trending) using invasive blood pressure monitor as a reference standard.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
non-invasive blood pressure monitor
non-invasive oscillometric blood pressure monitor will be applied at the arm, forearm, and at the wrist.
invasive blood pressure monitor
invasive blood pressure monitor will be connected to a cannula inserted at the radial artery.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* obese (with body mass index above 30 Kg/squared meter)
Exclusion Criteria
* Upper limb operations
* Upper limb scars
* Upper limb deep venous thrombosis
* Arrhythmias
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cairo University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ahmed Hasanin
Assistant professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ahmed Hasanin, Professor
Role: PRINCIPAL_INVESTIGATOR
Assistant professor of anesthesia
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cairo University
Cairo, , Egypt
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
N-72-2018
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.