Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A rare but terrible complication of vision loss has been known to occur after surgery, including spine surgery. It is commonly thought that increased intraocular pressure (IOP) is one of the reasons for this rare vision loss. It has been shown that the prone position can increase the IOP, and that tilting the patient with the head down can also increase IOP. The investigators will be measuring IOP before, during, and after a posterior spine surgery to see if the investigators can influence the intraocular pressure with elevated head position change. Two groups will be studied: one group of patients will receive standard care with the head in neutral position, while the other group will have the head slightly elevated 10 degrees during prone spine surgery.
It has been reported that postoperative vision loss after lumbar surgery is increasing. It is an uncommon but devastating complication. One of the risk factors that has been reported is increased intraocular pressure (IOP), which may decrease perfusion pressure to the optic nerve. Intraocular pressure in anesthetized, prone spine patients has been studied with the head in neutral position. The prone position and duration of the procedure did increase the IOP. Our hypothesis is that adjusting the position of the head in space will alter the intraocular pressure, with an extended position decreasing IOP. This study is a, randomized, controlled design: neutral head position (standard care) or extended head position (intervention group). Patients who qualify for spinal fusion surgery and meet the inclusion criteria will be randomized to either the neutral (standard practice) or the intervention group.Randomization of patients will be computer generated.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Head raised 10 degrees | Experimental | Head raised 10 degrees from neutral position using Gardner Wells tongs |
|
| Head in neutral position | Active Comparator | Head in neutral position |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Head raised 10 degrees | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Intraoperative Ocular Pressure in Lumbar Spine Fusion Patients Head Raised 10 Degrees or Kept in Neutral Position | 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). | Prone; 5 minutes after head raised to 10 degrees; every 15 minutes; 1 hr until end of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Change and Correlations in Intraoperative Ocular Pressure in Lumbar Spine Fusion Patients | The 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. | prone; every 15 minutes; 1 hr until end of surgery |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sanford E Emery, MD, MBA | West Virginia University | Principal Investigator |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15385367 | Background | Ozcan MS, Praetel C, Bhatti MT, Gravenstein N, Mahla ME, Seubert CN. The effect of body inclination during prone positioning on intraocular pressure in awake volunteers: a comparison of two operating tables. Anesth Analg. 2004 Oct;99(4):1152-1158. doi: 10.1213/01.ANE.0000130851.37039.50. | |
| 24456677 | Background |
Not provided
Not provided
Group data will be published. Not individual data.
Not provided
Not provided
Not provided
Not provided
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.
Subjects were recruited in the orthopaedic clinic at West Virginia University beginning November 2008 and recruitment ended February 2014.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
no significant differences in baseline demographics between the groups
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| 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 | Change in Intraoperative Ocular Pressure in Lumbar Spine Fusion Patients Head Raised 10 Degrees or Kept in Neutral Position | 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). | Subjects who were undergoing elective lumbar spine surgery. | Posted | Mean | 95% Confidence Interval | mm Hg | Prone; 5 minutes after head raised to 10 degrees; every 15 minutes; 1 hr until end of surgery |
|
One year
Follow up occurred at 2 weeks, 1 month, 3 month, 6 months, and 1 year.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| mild corneal abrasion | Eye disorders | Systematic Assessment | One patient sustained a mild corneal abrasion that resolved in 24 hours using ophthalmic ointment. |
The main limitation of our trial is that these were not consecutive cases, due to availability of the technician and a limited number of anesthesiologists on the protocol.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sanford Emery | West Virginia University | 304-293-1170 | semery@hsc.wvu.edu |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Head in neutral position | Procedure | 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. |
|
| Carey TW, Shaw KA, Weber ML, DeVine JG. Effect of the degree of reverse Trendelenburg position on intraocular pressure during prone spine surgery: a randomized controlled trial. Spine J. 2014 Sep 1;14(9):2118-26. doi: 10.1016/j.spinee.2013.12.025. Epub 2014 Jan 20. |
| 17978659 | Background | Walick KS, Kragh JE Jr, Ward JA, Crawford JJ. Changes in intraocular pressure due to surgical positioning: studying potential risk for postoperative vision loss. Spine (Phila Pa 1976). 2007 Nov 1;32(23):2591-5. doi: 10.1097/BRS.0b013e318158cc23. |
| 26582611 | Derived | Emery SE, Daffner SD, France JC, Ellison M, Grose BW, Hobbs GR, Clovis NB. Effect of Head Position on Intraocular Pressure During Lumbar Spine Fusion: A Randomized, Prospective Study. J Bone Joint Surg Am. 2015 Nov 18;97(22):1817-23. doi: 10.2106/JBJS.O.00091. |
| Withdrawal by Subject |
|
| coordinator contaminated with blood |
|
| subject cannot tolerate numbing drops |
|
| coordinator not available |
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Head in Neutral Position | 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. |
|
|
| Secondary | Change and Correlations in Intraoperative Ocular Pressure in Lumbar Spine Fusion Patients | The 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. | Not Posted | prone; every 15 minutes; 1 hr until end of surgery |
| 0 |
| 25 |
| 1 |
| 25 |
| EG001 | 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. | 0 | 27 | 0 | 27 |
|
Not provided
Not provided