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OpenTrials
Completed

NCT Number: NCT03757312

A Pilot Study of Optic Nerve Ultrasound Following Cardiopulmonary Bypass

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.

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Key information

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Ultrasound

Diagnostic Test

Ocular ultrasound to measure optic nerve sheath diameter (ONSD).

Primary outcomes

  1. 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

  1. Optic Nerve Sheath Diameter: Short Versus Long Cardiopulmonary Bypass (CPB) Time

    Time frame: Day of surgery

    Short CPB time defined as <100 minutes. Long CPB time defined as ≥ 100 minutes.

Sponsors and collaborators

Lead sponsor

Marco Corridore

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 28, 2018
Registry last updated
Sep 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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