NCT03640429

Brief Summary

Arterial blood pressure (ABP) monitoring is a corner stone in perioperative management. However, proper control of SBP requires accurate measurement of ABP. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 18, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 21, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

August 21, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2019

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

November 25, 2019

Status Verified

November 1, 2019

Enrollment Period

8 months

First QC Date

August 18, 2018

Last Update Submit

November 22, 2019

Conditions

ObesityBlood Pressure

Outcome Measures

Primary Outcomes (1)

  • Systolic blood pressure

    Systolic blood pressure measured in mmHg

    3 hours

Secondary Outcomes (5)

  • Diastolic blood pressure

    3 hours

  • mean blood pressure

    3 hours

  • Heart rate

    3 hours

  • Body mass index

    5 minutes

  • Arm circumference

    5 minutes

Interventions

non-invasive blood pressure monitorDEVICE

non-invasive oscillometric blood pressure monitor will be applied at the arm, forearm, and at the wrist.

invasive blood pressure monitorDEVICE

invasive blood pressure monitor will be connected to a cannula inserted at the radial artery.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult, obese, patients scheduled to surgery under general anesthesia will be included in the study. Arterial catheter will be inserted and used as a reference for evaluation of non-invasive blood pressure monitor at different sites.

You may qualify if:

  • Adult patients (aged above 18 years)
  • obese (with body mass index above 30 Kg/squared meter)

You may not qualify if:

  • Peripheral vascular diseases
  • Upper limb operations
  • Upper limb scars
  • Upper limb deep venous thrombosis
  • Arrhythmias

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, Egypt

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ahmed Hasanin, Professor

    Assistant professor of anesthesia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

August 18, 2018

First Posted

August 21, 2018

Study Start

August 21, 2018

Primary Completion

April 25, 2019

Study Completion

May 1, 2019

Last Updated

November 25, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)