A Pilot Study of Optic Nerve Ultrasound Following Cardiopulmonary Bypass

Congenital Heart Disease Clinical Trial

Official title:

A Pilot Study of Optic Nerve Ultrasound Following Cardiopulmonary Bypass

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03757312
• Other study ID #: IRB18-01209
• Status: Completed
• Phase: N/A
• Start date: April 24, 2019
• Est. completion date: January 16, 2020

Study information

• Verified date: September 2021
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: January 16, 2020
• Est. primary completion date: January 16, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Congenital Heart Defect
• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases

Intervention

Diagnostic Test:
• Ultrasound
Ocular ultrasound to measure optic nerve sheath diameter (ONSD).

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Marco Corridore

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Optic Nerve Sheath Diameter	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.	Day of surgery
Secondary	Optic Nerve Sheath Diameter: Short Versus Long Cardiopulmonary Bypass (CPB) Time	Short CPB time defined as <100 minutes. Long CPB time defined as = 100 minutes.	Day of surgery