Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06317168
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-19
First Post:
2024-03-11
Brief Title:
SIMPLifying Elements of Standardized Automated Office Blood Pressure Measurements Pilot Study
Sponsor:
Centre Integre Universitaire de Sante et Services Sociaux du Nord de lile de Montreal
Organization:
Centre Integre Universitaire de Sante et Services Sociaux du Nord de lile de Montreal
Study Overview
Official Title:
SIMPLifying Elements of Standardized Automated Office Blood Pressure Measurements Pilot Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SIMPLE-AOBP
Brief Summary:
This study aims to assess whether removing single elements of the standardized office BP measurement procedure will affect the accuracy towards the mean awake ambulatory BP Four arms are planned in a randomized order 1 full standardized procedure 2 standardized procedure but with cuff placed on a sleeve 3 standardized procedure but arm resting vertically 4 standardized procedure but with non-validated device
This is a pilot study to inform on the sample size required to perform adequately powered large scale studies
This is a pilot study to inform on the sample size required to perform adequately powered large scale studies
Detailed Description:
Accurate and reliable blood pressure BP measurements are key for hypertension management To this regard all hypertension societies recommend using highly standardized automated oscillometric office BP measurements AOBP as a way to minimise measurement biases enhance reproducibility and allow comparability The standardized AOBP procedure emphasizes the need to measure BP in a controlled environment with optimal body positioning the use of an appropriately sized cuff over a bare arm and a clinically validated oscillometric BP devices It is also recommended to average 2 measurements at 30-60 seconds intervals after several minutes of seated rest alone in a quiet room As such important barriers exist to implement standardized AOBP in real-life settings as this procedure requires time space and patient mobility
A 2017 meta-analysis evaluated the impact of several elements of oscillometric and auscultatory BP readings on systolic and diastolic BP levels It showed that while most components of BP measurements appear to influence BP the majority of included studies were of relatively low methodological quality including unstandardized BP measurements lack of randomisation auscultatory method absence or differences in rest periods single readings single cuff size and almost none were compared with th gold-standard BP measurement ie average awake ambulatory BP measurements ABPM Since two meta-analyses specifically assessing the effect of attendance during AOBP were published and showed conflicting results While important components of AOBP rest period and cuff size were recently tested using a rigorous methodology data is still missing for most elements
Simplifying the AOBP procedure could result in improvements in acceptability and implementation The need to perform this highly standardized procedure exerts pressure on patients providers and administrative staff Indeed patients need to be properly seated alone in a quiet dedicated room in a chair with an arm rest that need to be adjustable to position the upper arm at heart level This setup is seldom available apart in highly specialized hypertension clinics Also the arm must be bare which can bring discomfort to patients with the requirement to remove their clothing or roll up the sleeves which introduces another potential source of inaccuracy due to the tourniquet effect or the inability to completely uncover the upper arm It can also introduce significant time delays in a clinical setting for less mobile patients Furthermore the BP device must be clinically validated for its accuracy The lack of regulation and the ease of online purchase means many patients may be drawn to purchasing less expensive non-validated devices While this problem may be more widespread in the home setting not all office BP measuring devices are validated and recommended by Hypertension Canada
The primary objective of the SIMPLE-AOBP study is to assess whether foregoing or simplifying specific elements of the AOBP procedure affects its accuracy towards the gold-standard mean awake ABPM This study will employ a rigorous methodology highly standardized measurements identical settings and rest periods randomization blinded assessment of outcomes averaged multiple BP measurements to minimise measurement biases not related to the studies elements The study will focus on three easily addressable elements 1 the need the measure BP on a bare arm 2 the requirement of supporting the arm at heart level and 3 the need to use a validated BP device This trial will provide important pilot data to help design adequately powered large scale studies
A 2017 meta-analysis evaluated the impact of several elements of oscillometric and auscultatory BP readings on systolic and diastolic BP levels It showed that while most components of BP measurements appear to influence BP the majority of included studies were of relatively low methodological quality including unstandardized BP measurements lack of randomisation auscultatory method absence or differences in rest periods single readings single cuff size and almost none were compared with th gold-standard BP measurement ie average awake ambulatory BP measurements ABPM Since two meta-analyses specifically assessing the effect of attendance during AOBP were published and showed conflicting results While important components of AOBP rest period and cuff size were recently tested using a rigorous methodology data is still missing for most elements
Simplifying the AOBP procedure could result in improvements in acceptability and implementation The need to perform this highly standardized procedure exerts pressure on patients providers and administrative staff Indeed patients need to be properly seated alone in a quiet dedicated room in a chair with an arm rest that need to be adjustable to position the upper arm at heart level This setup is seldom available apart in highly specialized hypertension clinics Also the arm must be bare which can bring discomfort to patients with the requirement to remove their clothing or roll up the sleeves which introduces another potential source of inaccuracy due to the tourniquet effect or the inability to completely uncover the upper arm It can also introduce significant time delays in a clinical setting for less mobile patients Furthermore the BP device must be clinically validated for its accuracy The lack of regulation and the ease of online purchase means many patients may be drawn to purchasing less expensive non-validated devices While this problem may be more widespread in the home setting not all office BP measuring devices are validated and recommended by Hypertension Canada
The primary objective of the SIMPLE-AOBP study is to assess whether foregoing or simplifying specific elements of the AOBP procedure affects its accuracy towards the gold-standard mean awake ABPM This study will employ a rigorous methodology highly standardized measurements identical settings and rest periods randomization blinded assessment of outcomes averaged multiple BP measurements to minimise measurement biases not related to the studies elements The study will focus on three easily addressable elements 1 the need the measure BP on a bare arm 2 the requirement of supporting the arm at heart level and 3 the need to use a validated BP device This trial will provide important pilot data to help design adequately powered large scale studies
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None