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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fontan | Experimental | Patients undergoing Fontan procedure to redirect blood flow from the lower body to the lungs. |
|
| Non-Fontan | Active Comparator | Patients undergoing other cardiac surgeries requiring cardiopulmonary bypass. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound | Diagnostic Test | Ocular ultrasound to measure optic nerve sheath diameter (ONSD). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day of surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marco Corridore, MD | Nationwide Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Fontan | Patients undergoing Fontan procedure to redirect blood flow from the lower body to the lungs. Ultrasound: Ocular ultrasound to measure optic nerve sheath diameter (ONSD). |
| FG001 | Non-Fontan | Patients undergoing other cardiac surgeries requiring cardiopulmonary bypass. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fontan | Patients undergoing Fontan procedure to redirect blood flow from the lower body to the lungs. Ultrasound: Ocular ultrasound to measure optic nerve sheath diameter (ONSD). |
| BG001 | Non-Fontan |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Full Range | millimeters | Day of surgery |
|
24 hours post-op
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fontan | Patients undergoing Fontan procedure to redirect blood flow from the lower body to the lungs. Ultrasound: Ocular ultrasound to measure optic nerve sheath diameter (ONSD). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marco Corridore, MD | Nationwide Children's Hospital | 614-722-4200 | Marco.Corridore@nationwidechildrens.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 10, 2018 | Aug 12, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
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| ID | Term |
|---|---|
| D014463 | Ultrasonography |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Patients undergoing other cardiac surgeries requiring cardiopulmonary bypass.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Weight | Mean | Full Range | kilograms |
|
| Height | Mean | Full Range | centimeters |
|
| American Society of Anesthesiologists (ASA) status | ASA 1 - normal healthy patient, ASA 2 - mild disease, ASA 3 - severe systemic disease, ASA 4 - severe systemic disease that is a constant threat to life | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | 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. | Posted | Mean | Full Range | millimeters | Day of surgery |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | Non-Fontan | Patients undergoing other cardiac surgeries requiring cardiopulmonary bypass. | 0 | 9 | 0 | 9 | 0 | 9 |
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| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| Following tracheal extubation in the OR |
|