- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03220906
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
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.
Sponsor
Collaborators
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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