Trial Outcomes & Findings for Intraoperative Ocular Pressure in Lumbar Spine Fusion Patients (NCT NCT02342288)
NCT ID: NCT02342288
Last Updated: 2016-02-24
Results Overview
The objective is to determine if slight elevation of the head (10 degrees up from neutral) can decrease the IOP compared to remaining in neutral position (standard of care) for the entire surgery. The mean values for Δ IOP measurements (i.e. two eye average maximum IOP - two eye average baseline IOP obtained at first prone measurement).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
79 participants
Primary outcome timeframe
Prone; 5 minutes after head raised to 10 degrees; every 15 minutes; 1 hr until end of surgery
Results posted on
2016-02-24
Participant Flow
Subjects were recruited in the orthopaedic clinic at West Virginia University beginning November 2008 and recruitment ended February 2014.
Seventy-nine patients were consented and enrolled. Sixty-three were randomized. Twenty-seven patients did not complete the study. Of the 27, 16 were never randomized. The number of patients who were randomized, started the study and received full treatment or placebo was 52. Reasons are listed below for those who did not complete the study.
Participant milestones
| Measure |
Head Raised 10 Degrees
Head raised 10 degrees from neutral position using Gardner Wells tongs
Head raised 10 degrees: Baseline measurement in seated position; anesthetization in the supine position. Prior to turning into the prone position, another measurement was taken. Five minutes after turning prone, a third IOP measurement was obtained. Head was raised to 10 degrees. After 5 minutes a fourth IOP measurement was performed. Repeat measurements were taken every 15 minutes until three sequential measurements were within plus or minus 3 mmHg of one another; thereafter, measurements were obtained every hour until end of case. A final measurement was taken after turning the patient supine and 5 minutes elapsed for equilibration.
|
Head in Neutral Position
Head in neutral position
Head in neutral position: Baseline measurement in seated position; anesthetization in the supine position. Prior to turning into the prone position, another measurement was taken. Five minutes after turning prone, a third IOP measurement was obtained. After 5 minutes a fourth IOP measurement was performed. Repeat measurements were taken every 15 minutes until three sequential measurements were within plus or minus 3 mmHg of one another; thereafter, measurements were obtained every hour until end of case. A final measurement was taken after turning the patient supine and 5 minutes elapsed for equilibration.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
33
|
|
Overall Study
COMPLETED
|
25
|
27
|
|
Overall Study
NOT COMPLETED
|
5
|
6
|
Reasons for withdrawal
| Measure |
Head Raised 10 Degrees
Head raised 10 degrees from neutral position using Gardner Wells tongs
Head raised 10 degrees: Baseline measurement in seated position; anesthetization in the supine position. Prior to turning into the prone position, another measurement was taken. Five minutes after turning prone, a third IOP measurement was obtained. Head was raised to 10 degrees. After 5 minutes a fourth IOP measurement was performed. Repeat measurements were taken every 15 minutes until three sequential measurements were within plus or minus 3 mmHg of one another; thereafter, measurements were obtained every hour until end of case. A final measurement was taken after turning the patient supine and 5 minutes elapsed for equilibration.
|
Head in Neutral Position
Head in neutral position
Head in neutral position: Baseline measurement in seated position; anesthetization in the supine position. Prior to turning into the prone position, another measurement was taken. Five minutes after turning prone, a third IOP measurement was obtained. After 5 minutes a fourth IOP measurement was performed. Repeat measurements were taken every 15 minutes until three sequential measurements were within plus or minus 3 mmHg of one another; thereafter, measurements were obtained every hour until end of case. A final measurement was taken after turning the patient supine and 5 minutes elapsed for equilibration.
|
|---|---|---|
|
Overall Study
no protocol anesthesiologist available
|
3
|
2
|
|
Overall Study
anesthesia leak in system
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
coordinator contaminated with blood
|
0
|
1
|
|
Overall Study
subject cannot tolerate numbing drops
|
0
|
1
|
|
Overall Study
coordinator not available
|
0
|
2
|
Baseline Characteristics
Intraoperative Ocular Pressure in Lumbar Spine Fusion Patients
Baseline characteristics by cohort
| Measure |
Head Raised 10 Degrees
n=25 Participants
Head raised 10 degrees from neutral position using Gardner Wells tongs
Head raised 10 degrees: Baseline measurement in seated position; anesthetization in the supine position. Prior to turning into the prone position, another measurement was taken. Five minutes after turning prone, a third IOP measurement was obtained. Head was raised to 10 degrees. After 5 minutes a fourth IOP measurement was performed. Repeat measurements were taken every 15 minutes until three sequential measurements were within plus or minus 3 mmHg of one another; thereafter, measurements were obtained every hour until end of case. A final measurement was taken after turning the patient supine and 5 minutes elapsed for equilibration.
|
Head in Neutral Position
n=27 Participants
Head in neutral position
Head in neutral position: Baseline measurement in seated position; anesthetization in the supine position. Prior to turning into the prone position, another measurement was taken. Five minutes after turning prone, a third IOP measurement was obtained. After 5 minutes a fourth IOP measurement was performed. Repeat measurements were taken every 15 minutes until three sequential measurements were within plus or minus 3 mmHg of one another; thereafter, measurements were obtained every hour until end of case. A final measurement was taken after turning the patient supine and 5 minutes elapsed for equilibration.
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
25 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
27 participants
n=7 Participants
|
52 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Prone; 5 minutes after head raised to 10 degrees; every 15 minutes; 1 hr until end of surgeryPopulation: Subjects who were undergoing elective lumbar spine surgery.
The objective is to determine if slight elevation of the head (10 degrees up from neutral) can decrease the IOP compared to remaining in neutral position (standard of care) for the entire surgery. The mean values for Δ IOP measurements (i.e. two eye average maximum IOP - two eye average baseline IOP obtained at first prone measurement).
Outcome measures
| Measure |
Head Raised 10 Degrees
n=25 Participants
Head raised 10 degrees from neutral position using Gardner Wells tongs
Head raised 10 degrees: Five minutes after turning prone, an IOP measurement was obtained. Head was raised to 10 degrees. After 5 minutes an IOP measurement was performed. Repeat measurements were taken every 15 minutes until three sequential measurements were within plus or minus 3 mmHg of one another; thereafter, measurements were obtained every hour until end of case. A final measurement was taken after turning the patient supine and 5 minutes elapsed for equilibration.
|
Head in Neutral Position
n=27 Participants
Head in neutral position
Head in neutral position: Five minutes after turning prone, an IOP measurement was obtained. After 5 minutes an IOP measurement was taken. Repeat measurements were taken every 15 minutes until three sequential measurements were within plus or minus 3 mmHg of one another; thereafter, measurements were obtained every hour until end of case. A final measurement was taken after turning the patient supine and 5 minutes elapsed for equilibration.
|
|---|---|---|
|
Change in Intraoperative Ocular Pressure in Lumbar Spine Fusion Patients Head Raised 10 Degrees or Kept in Neutral Position
|
9.26 mm Hg
Interval 6.65 to 11.87
|
13.79 mm Hg
Interval 10.6 to 16.97
|
SECONDARY outcome
Timeframe: prone; every 15 minutes; 1 hr until end of surgeryThe secondary outcome is to evaluate factors (age, gender, duration of procedure, blood loss, intraoperative fluids, blood pressure, and carbon dioxide levels) looking for correlations with intraocular pressure changes.
Outcome measures
Outcome data not reported
Adverse Events
Head Raised 10 Degrees
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Head in Neutral Position
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Head Raised 10 Degrees
n=25 participants at risk
Head raised 10 degrees from neutral position using Gardner Wells tongs
Head raised 10 degrees: Baseline measurement in seated position; anesthetization in the supine position. Prior to turning into the prone position, another measurement was taken. Five minutes after turning prone, a third IOP measurement was obtained. Head was raised to 10 degrees. After 5 minutes a fourth IOP measurement was performed. Repeat measurements were taken every 15 minutes until three sequential measurements were within plus or minus 3 mmHg of one another; thereafter, measurements were obtained every hour until end of case. A final measurement was taken after turning the patient supine and 5 minutes elapsed for equilibration.
|
Head in Neutral Position
n=27 participants at risk
Head in neutral position
Head in neutral position: Baseline measurement in seated position; anesthetization in the supine position. Prior to turning into the prone position, another measurement was taken. Five minutes after turning prone, a third IOP measurement was obtained. After 5 minutes a fourth IOP measurement was performed. Repeat measurements were taken every 15 minutes until three sequential measurements were within plus or minus 3 mmHg of one another; thereafter, measurements were obtained every hour until end of case. A final measurement was taken after turning the patient supine and 5 minutes elapsed for equilibration.
|
|---|---|---|
|
Eye disorders
mild corneal abrasion
|
4.0%
1/25 • Number of events 1 • One year
Follow up occurred at 2 weeks, 1 month, 3 month, 6 months, and 1 year.
|
0.00%
0/27 • One year
Follow up occurred at 2 weeks, 1 month, 3 month, 6 months, and 1 year.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place