A Pilot Study of Optic Nerve Ultrasound Following Cardiopulmonary Bypass

Marco Corridore

Status: Completed

Conditions: Congenital Heart Defect; Congenital Heart Disease

Treatments: Diagnostic Test: Ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT03757312

IRB18-01209

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• None

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 2 patient groups

Fontan

Experimental group

Description:

Patients undergoing Fontan procedure to redirect blood flow from the lower body to the lungs.

Treatment:

Diagnostic Test: Ultrasound

Non-Fontan

Active Comparator group

Description:

Patients undergoing other cardiac surgeries requiring cardiopulmonary bypass.

Treatment:

Diagnostic Test: Ultrasound