NCT03220906

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2017

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 14, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 18, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

August 21, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 2, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 2, 2018

Completed
Last Updated

August 31, 2018

Status Verified

August 1, 2018

Enrollment Period

11 months

First QC Date

July 14, 2017

Last Update Submit

August 30, 2018

Conditions

Surgery

Outcome Measures

Primary Outcomes (1)

  • Deviation >5 mmHg in MAP

    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 Outcomes (1)

  • Deviation >10 mmHg

    45 minutes

Study Arms (1)

Arterial line

Children undergoing surgical procedure with planned arterial cannula placement.

Other: Blood pressure measurement

Interventions

Blood pressure measurementOTHER

Blood pressure will be measured in both upper and lower extremities.

Arterial line

Eligibility Criteria

AgeUp to 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chairman, Dept. of Anesthesiology & Pain Medicine

Study Record Dates

First Submitted

July 14, 2017

First Posted

July 18, 2017

Study Start

August 21, 2017

Primary Completion

July 2, 2018

Study Completion

July 2, 2018

Last Updated

August 31, 2018

Record last verified: 2018-08

Locations

US(1)