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A Pilot Study of Optic Nerve Ultrasound Following Cardiopulmonary Bypass

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ClinicalTrials.gov Identifier: NCT03757312
Recruitment Status : Completed
First Posted : November 28, 2018
Results First Posted : September 13, 2021
Last Update Posted : September 13, 2021
Sponsor:
Information provided by (Responsible Party):
Marco Corridore, Nationwide Children's Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Congenital Heart Disease Congenital Heart Defect Diagnostic Test: Ultrasound Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Pilot Study of Optic Nerve Ultrasound Following Cardiopulmonary Bypass
Actual Study Start Date : April 24, 2019
Actual Primary Completion Date : January 16, 2020
Actual Study Completion Date : January 16, 2020
Arms and Interventions
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Arm Intervention/treatment
Experimental: Fontan
Patients undergoing Fontan procedure to redirect blood flow from the lower body to the lungs.
 Diagnostic Test: Ultrasound
Ocular ultrasound to measure optic nerve sheath diameter (ONSD).
Active Comparator: Non-Fontan
Patients undergoing other cardiac surgeries requiring cardiopulmonary bypass.
 Diagnostic Test: Ultrasound
Ocular ultrasound to measure optic nerve sheath diameter (ONSD).


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03757312


Locations
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United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Marco Corridore
Investigators
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Principal Investigator: Marco Corridore, MD Nationwide Children's Hospital
  Study Documents (Full-Text)

Documents provided by Marco Corridore, Nationwide Children's Hospital:
Study Protocol and Statistical Analysis Plan  [PDF] December 10, 2018

More Information
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Responsible Party: Marco Corridore, Associate Professor of Anesthesiology, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT03757312    
Other Study ID Numbers: IRB18-01209
First Posted: November 28, 2018    Key Record Dates
Results First Posted: September 13, 2021
Last Update Posted: September 13, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Marco Corridore, Nationwide Children's Hospital:
cardiopulmonary bypass
Additional relevant MeSH terms:
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Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities