Trial Outcomes & Findings for A Pilot Study of Optic Nerve Ultrasound Following Cardiopulmonary Bypass (NCT NCT03757312)
NCT ID: NCT03757312
Last Updated: 2021-09-13
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
14 participants
Primary outcome timeframe
Day of surgery
Results posted on
2021-09-13
Participant Flow
Participant milestones
| Measure |
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).
|
Non-Fontan
Patients undergoing other cardiac surgeries requiring cardiopulmonary bypass.
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
9
|
|
Overall Study
COMPLETED
|
5
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Fontan
n=5 Participants
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).
|
Non-Fontan
n=9 Participants
Patients undergoing other cardiac surgeries requiring cardiopulmonary bypass.
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
5 Participants
n=5 Participants
|
9 Participants
n=9 Participants
|
14 Participants
n=14 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=14 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=14 Participants
|
|
Age, Continuous
|
2.6 years
n=5 Participants
|
1.3 years
n=9 Participants
|
1.8 years
n=14 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
4 Participants
n=9 Participants
|
7 Participants
n=14 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
5 Participants
n=9 Participants
|
7 Participants
n=14 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
9 participants
n=9 Participants
|
14 participants
n=14 Participants
|
|
Weight
|
13.5 kilograms
n=5 Participants
|
9.3 kilograms
n=9 Participants
|
10.8 kilograms
n=14 Participants
|
|
Height
|
88.2 centimeters
n=5 Participants
|
74.3 centimeters
n=9 Participants
|
79.2 centimeters
n=14 Participants
|
|
American Society of Anesthesiologists (ASA) status
ASA 3
|
0 Participants
n=5 Participants
|
2 Participants
n=9 Participants
|
2 Participants
n=14 Participants
|
|
American Society of Anesthesiologists (ASA) status
ASA 4
|
5 Participants
n=5 Participants
|
7 Participants
n=9 Participants
|
12 Participants
n=14 Participants
|
PRIMARY outcome
Timeframe: Day of surgeryOptic 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.
Outcome measures
| Measure |
Fontan
n=5 Participants
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).
|
Non-Fontan
n=9 Participants
Patients undergoing other cardiac surgeries requiring cardiopulmonary bypass.
|
|---|---|---|
|
Optic Nerve Sheath Diameter
Following tracheal extubation in the OR
|
4.2 millimeters
Interval 3.2 to 5.3
|
3.7 millimeters
Interval 3.0 to 4.3
|
|
Optic Nerve Sheath Diameter
Post induction of anesthesia
|
4.0 millimeters
Interval 3.0 to 4.6
|
3.6 millimeters
Interval 3.1 to 3.9
|
|
Optic Nerve Sheath Diameter
After coming off of CPB
|
4.2 millimeters
Interval 3.5 to 5.1
|
3.5 millimeters
Interval 3.1 to 3.9
|
SECONDARY outcome
Timeframe: Day of surgeryShort CPB time defined as \<100 minutes. Long CPB time defined as ≥ 100 minutes.
Outcome measures
| Measure |
Fontan
n=7 Participants
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).
|
Non-Fontan
n=7 Participants
Patients undergoing other cardiac surgeries requiring cardiopulmonary bypass.
|
|---|---|---|
|
Optic Nerve Sheath Diameter: Short Versus Long Cardiopulmonary Bypass (CPB) Time
Post-induction of anesthesia
|
3.8 millimeters
Interval 3.6 to 4.0
|
3.6 millimeters
Interval 3.0 to 4.6
|
|
Optic Nerve Sheath Diameter: Short Versus Long Cardiopulmonary Bypass (CPB) Time
After coming off of CPB
|
3.6 millimeters
Interval 3.5 to 3.9
|
3.8 millimeters
Interval 3.1 to 5.1
|
|
Optic Nerve Sheath Diameter: Short Versus Long Cardiopulmonary Bypass (CPB) Time
Following tracheal extubation in the OR
|
3.8 millimeters
Interval 3.5 to 4.3
|
3.8 millimeters
Interval 3.0 to 5.3
|
Adverse Events
Fontan
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Non-Fontan
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place