- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03757312
A Pilot Study of Optic Nerve Ultrasound Following Cardiopulmonary Bypass
September 10, 2021 updated by: Marco Corridore
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
14
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43205
- Nationwide Children's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients less than 18 years of age undergoing cardiac bypass.
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Fontan
Patients undergoing Fontan procedure to redirect blood flow from the lower body to the lungs.
|
Ocular ultrasound to measure optic nerve sheath diameter (ONSD).
|
Active Comparator: Non-Fontan
Patients undergoing other cardiac surgeries requiring cardiopulmonary bypass.
|
Ocular ultrasound to measure optic nerve sheath diameter (ONSD).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Optic Nerve Sheath Diameter
Time Frame: 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.
|
Day of surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Optic Nerve Sheath Diameter: Short Versus Long Cardiopulmonary Bypass (CPB) Time
Time Frame: Day of surgery
|
Short CPB time defined as <100 minutes.
Long CPB time defined as ≥ 100 minutes.
|
Day of surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Marco Corridore, MD, Nationwide Children's Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 24, 2019
Primary Completion (Actual)
January 16, 2020
Study Completion (Actual)
January 16, 2020
Study Registration Dates
First Submitted
November 27, 2018
First Submitted That Met QC Criteria
November 27, 2018
First Posted (Actual)
November 28, 2018
Study Record Updates
Last Update Posted (Actual)
September 13, 2021
Last Update Submitted That Met QC Criteria
September 10, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB18-01209
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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