Comparison of Blood Pressure Measurements in Upper and Lower Extremities in Children Under General Anesthesia

August 30, 2018 updated by: Joseph D. Tobias, Nationwide Children's Hospital
There is very little information comparing non-invasive blood pressure (BP) readings obtained from upper and lower limbs, as well as comparing invasive and non-invasive blood pressures in the children under anesthesia. This study seeks to determine the correlation between the non-invasive BP measurements between upper and lower extremities and compare these measurements with the invasive BP as the standard for comparison.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ohio
      • Columbus, Ohio, United States, 43205
        • Nationwide Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children undergoing a surgical procedure with planned arterial cannula placement at Nationwide Children's Hospital in Columbus, OH or King Fahad Medical City in Riyadh, Saudi Arabia.

Description

Inclusion Criteria:

  • ASA status 1-3
  • 0-10 years of age
  • Undergoing surgical procedure with planned arterial cannula placement

Exclusion Criteria:

  • ASA status >3
  • Older than 10 years of age
  • Patient unable to have BP taken on 1 upper and 1 lower extremity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Arterial line
Children undergoing surgical procedure with planned arterial cannula placement.
Blood pressure will be measured in both upper and lower extremities.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Deviation >5 mmHg in MAP
Time Frame: 45 minutes
Deviation >5 mmHg in MAP between one of the non-invasive measurements compared to invasive BP measurement at any point during the study.
45 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Deviation >10 mmHg
Time Frame: 45 minutes
Deviation >10 mmHg between the non-invasive and invasive measurements.
45 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 21, 2017

Primary Completion (Actual)

July 2, 2018

Study Completion (Actual)

July 2, 2018

Study Registration Dates

First Submitted

July 14, 2017

First Submitted That Met QC Criteria

July 14, 2017

First Posted (Actual)

July 18, 2017

Study Record Updates

Last Update Posted (Actual)

August 31, 2018

Last Update Submitted That Met QC Criteria

August 30, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • IRB17-00268

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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