Congenital Heart Defect, Congenital Heart Disease
Conditions
Keywords
cardiopulmonary bypass
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.
Interventions
DIAGNOSTIC_TESTUltrasound
Ocular ultrasound to measure optic nerve sheath diameter (ONSD).
Sponsors
Marco Corridore
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
Inclusion criteria
* Patients less than 18 years of age undergoing cardiac bypass.
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Optic Nerve Sheath Diameter | 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
| Measure | Time frame | Description |
|---|---|---|
| Optic Nerve Sheath Diameter: Short Versus Long Cardiopulmonary Bypass (CPB) Time | Day of surgery | Short CPB time defined as \<100 minutes. Long CPB time defined as ≥ 100 minutes. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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). | 5 |
| Non-Fontan Patients undergoing other cardiac surgeries requiring cardiopulmonary bypass. | 9 |
| Total | 14 |
Baseline characteristics
| Characteristic | Fontan | Non-Fontan | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 5 Participants | 9 Participants | 14 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 2.6 years | 1.3 years | 1.8 years |
| American Society of Anesthesiologists (ASA) status ASA 3 | 0 Participants | 2 Participants | 2 Participants |
| American Society of Anesthesiologists (ASA) status ASA 4 | 5 Participants | 7 Participants | 12 Participants |
| Height | 88.2 centimeters | 74.3 centimeters | 79.2 centimeters |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 5 participants | 9 participants | 14 participants |
| Sex: Female, Male Female | 3 Participants | 4 Participants | 7 Participants |
| Sex: Female, Male Male | 2 Participants | 5 Participants | 7 Participants |
| Weight | 13.5 kilograms | 9.3 kilograms | 10.8 kilograms |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 9 |
| other Total, other adverse events | 0 / 5 | 0 / 9 |
| serious Total, serious adverse events | 0 / 5 | 0 / 9 |
Outcome results
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.
Time frame: Day of surgery
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Fontan | Optic Nerve Sheath Diameter | Post induction of anesthesia | 4.0 millimeters |
| Fontan | Optic Nerve Sheath Diameter | After coming off of CPB | 4.2 millimeters |
| Fontan | Optic Nerve Sheath Diameter | Following tracheal extubation in the OR | 4.2 millimeters |
| Non-Fontan | Optic Nerve Sheath Diameter | Post induction of anesthesia | 3.6 millimeters |
| Non-Fontan | Optic Nerve Sheath Diameter | After coming off of CPB | 3.5 millimeters |
| Non-Fontan | Optic Nerve Sheath Diameter | Following tracheal extubation in the OR | 3.7 millimeters |
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.
Time frame: Day of surgery
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Fontan | Optic Nerve Sheath Diameter: Short Versus Long Cardiopulmonary Bypass (CPB) Time | Post-induction of anesthesia | 3.8 millimeters |
| Fontan | Optic Nerve Sheath Diameter: Short Versus Long Cardiopulmonary Bypass (CPB) Time | After coming off of CPB | 3.6 millimeters |
| Fontan | Optic Nerve Sheath Diameter: Short Versus Long Cardiopulmonary Bypass (CPB) Time | Following tracheal extubation in the OR | 3.8 millimeters |
| Non-Fontan | Optic Nerve Sheath Diameter: Short Versus Long Cardiopulmonary Bypass (CPB) Time | Post-induction of anesthesia | 3.6 millimeters |
| Non-Fontan | Optic Nerve Sheath Diameter: Short Versus Long Cardiopulmonary Bypass (CPB) Time | After coming off of CPB | 3.8 millimeters |
| Non-Fontan | Optic Nerve Sheath Diameter: Short Versus Long Cardiopulmonary Bypass (CPB) Time | Following tracheal extubation in the OR | 3.8 millimeters |