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Clinical Trials/NCT03757312
NCT03757312
Completed
Not Applicable

A Pilot Study of Optic Nerve Ultrasound Following Cardiopulmonary Bypass

Marco Corridore1 site in 1 country14 target enrollmentApril 24, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Congenital Heart Disease
Sponsor
Marco Corridore
Enrollment
14
Locations
1
Primary Endpoint
Optic Nerve Sheath Diameter
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

The purpose of the proposed study is to evaluate the incidence of subtle increases in intracranial pressure (ICP) following cardiopulmonary bypass (CPB) using optic nerve sheath diameter (ONSD), measured by non-invasive ultrasound. As direct measurements of ICP are not feasible following CPB, ONSD will be used as a correlate of ICP. ONSD has been shown to be effective in the ICU and emergency room setting for detecting increased ICP and is an accepted standard for such measurements. The primary hypothesis is that changes in ICP occur following CPB without clinically appreciable signs and symptoms. These changes in ICP will be reflected by changes in ONSD. If there is a significant incidence of sub-clinical cerebral edema and increased ICP postoperatively, these findings may impact postoperative hemodynamic and ventilation goals and techniques.

Registry
clinicaltrials.gov
Start Date
April 24, 2019
End Date
January 16, 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Marco Corridore
Responsible Party
Sponsor Investigator
Principal Investigator

Marco Corridore

Associate Professor of Anesthesiology

Nationwide Children's Hospital

Eligibility Criteria

Inclusion Criteria

  • Patients less than 18 years of age undergoing cardiac bypass.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Optic Nerve Sheath Diameter

Time Frame: Day of surgery

Optic nerve sheath diameter normal values: ≤4.0 mm for patients \<1 year and ≤4.5 mm used for patients ≥1 year of age, thus there is potential for worse outcomes with higher diameters.

Secondary Outcomes

  • Optic Nerve Sheath Diameter: Short Versus Long Cardiopulmonary Bypass (CPB) Time(Day of surgery)

Study Sites (1)

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