A Pilot Study of Optic Nerve Ultrasound Following Cardiopulmonary Bypass

Not Applicable

Completed

• Conditions: Congenital Heart Disease; Congenital Heart Defect
• Interventions: Diagnostic Test: Ultrasound

• Registration Number: NCT03757312
• Lead Sponsor: Marco Corridore

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-11-27
• Study First Submitted QC: 2018-11-27
• Study First Posted: 2018-11-28
• Study Start: 2019-04-24
• Primary Completion: 2020-01-16
• Study Completion: 2020-01-16
• Results First Submitted: 2021-08-16
• Status Verified: 2021-09
• Results First Submitted QC: 2021-09-10
• Last Update Submitted: 2021-09-10
• Results First Posted: 2021-09-13
• Last Update Posted: 2021-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

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

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fontan	Ultrasound	Patients undergoing Fontan procedure to redirect blood flow from the lower body to the lungs.
Non-Fontan	Ultrasound	Patients undergoing other cardiac surgeries requiring cardiopulmonary bypass.

Primary Outcome Measures

Name	Time	Method
Optic Nerve Sheath Diameter	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 Outcome Measures

Name	Time	Method
Optic Nerve Sheath Diameter: Short Versus Long Cardiopulmonary Bypass (CPB) Time	Day of surgery	Short CPB time defined as \<100 minutes. Long CPB time defined as ≥ 100 minutes.

Trial Locations

Locations (1)

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States