Back to resultsA Pilot Study of Optic Nerve Ultrasound Following Cardiopulmonary Bypass
Primary Purpose
Congenital Heart Disease, Congenital Heart Defect
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ultrasound
Sponsored by
About this trial
This is an interventional diagnostic trial for Congenital Heart Disease focused on measuring cardiopulmonary bypass
Eligibility Criteria
Inclusion Criteria:
- Patients less than 18 years of age undergoing cardiac bypass.
Exclusion Criteria:
- None
Sites / Locations
- Nationwide Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Fontan
Non-Fontan
Arm Description
Patients undergoing Fontan procedure to redirect blood flow from the lower body to the lungs.
Patients undergoing other cardiac surgeries requiring cardiopulmonary bypass.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03757312
Brief Title
A Pilot Study of Optic Nerve Ultrasound Following Cardiopulmonary Bypass
Official Title
A Pilot Study of Optic Nerve Ultrasound Following Cardiopulmonary Bypass
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
April 24, 2019 (Actual)
Primary Completion Date
January 16, 2020 (Actual)
Study Completion Date
January 16, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Marco Corridore
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Disease, Congenital Heart Defect
Keywords
cardiopulmonary bypass
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fontan
Arm Type
Experimental
Arm Description
Patients undergoing Fontan procedure to redirect blood flow from the lower body to the lungs.
Arm Title
Non-Fontan
Arm Type
Active Comparator
Arm Description
Patients undergoing other cardiac surgeries requiring cardiopulmonary bypass.
Intervention Type
Diagnostic Test
Intervention Name(s)
Ultrasound
Intervention Description
Ocular ultrasound to measure optic nerve sheath diameter (ONSD).
Primary Outcome Measure Information:
Title
Optic Nerve Sheath Diameter
Description
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.
Time Frame
Day of surgery
Secondary Outcome Measure Information:
Title
Optic Nerve Sheath Diameter: Short Versus Long Cardiopulmonary Bypass (CPB) Time
Description
Short CPB time defined as <100 minutes. Long CPB time defined as ≥ 100 minutes.
Time Frame
Day of surgery
10. Eligibility
Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients less than 18 years of age undergoing cardiac bypass.
Exclusion Criteria:
None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marco Corridore, MD
Organizational Affiliation
Nationwide Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Pilot Study of Optic Nerve Ultrasound Following Cardiopulmonary Bypass
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