A Pilot Study of Optic Nerve Ultrasound Following Cardiopulmonary Bypass

NCT ID: NCT03757312

Last Updated: 2021-09-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-24
• Study Completion Date: 2020-01-16

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.

Conditions

Congenital Heart Disease; Congenital Heart Defect

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Fontan

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

Group Type: EXPERIMENTAL

Ultrasound

Intervention Type: DIAGNOSTIC_TEST

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

Non-Fontan

Patients undergoing other cardiac surgeries requiring cardiopulmonary bypass.

Group Type: ACTIVE_COMPARATOR

Ultrasound

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Ultrasound

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• None

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Marco Corridore

OTHER

Sponsor Role: lead

Responsible Party

Marco Corridore

Associate Professor of Anesthesiology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Marco Corridore, MD

Role: PRINCIPAL_INVESTIGATOR

Nationwide Children's Hospital

Locations

Nationwide Children's Hospital

Columbus, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB18-01209

Identifier Type: -

Identifier Source: org_study_id