A Pilot Study of Optic Nerve Ultrasound Following Cardiopulmonary Bypass

NCT03757312 | Completed Results FDA Device

• 1 other identifier: IRB18-01209
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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

Keywords

cardiopulmonary bypass

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  Day of surgery

Study Arms (2)

Fontan

EXPERIMENTAL

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

Diagnostic Test: Ultrasound

Non-Fontan

ACTIVE COMPARATOR

Patients undergoing other cardiac surgeries requiring cardiopulmonary bypass.

Diagnostic Test: Ultrasound

Interventions

Ultrasound DIAGNOSTIC_TEST

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

Fontan; Non-Fontan

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Marco Corridore: lead

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Results Point of Contact

• Title: Marco Corridore, MD
• Organization: Nationwide Children's Hospital

Marco.Corridore@nationwidechildrens.org

614-722-4200

Study Officials

• Marco Corridore, MD

  Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology

Study Record Dates

• First Submitted: November 27, 2018
• First Posted: November 28, 2018
• Study Start: April 24, 2019
• Primary Completion: January 16, 2020
• Study Completion: January 16, 2020
• Last Updated: September 13, 2021
• Results First Posted: September 13, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)