Intraoperative Ocular Pressure in Lumbar Spine Fusion Patients

NCT02342288 | Completed Results

• 1 other identifier: 1409441146
• Study Type: interventional
• Target: 79
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Raised Ocular Pressure

Keywords

Intraoperative ocular pressure

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Change and Correlations in Intraoperative Ocular Pressure in Lumbar Spine Fusion Patients

  prone; every 15 minutes; 1 hr until end of surgery

Study Arms (2)

Head raised 10 degrees

EXPERIMENTAL

Head raised 10 degrees from neutral position using Gardner Wells tongs

Procedure: Head raised 10 degrees

Head in neutral position

ACTIVE COMPARATOR

Head in neutral position

Procedure: Head in neutral position

Interventions

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.

Head raised 10 degrees

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.

Head in neutral position

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing elective lumbar spinal fusion surgery; ages 18-80

You may not qualify if:

• Less than 18 years of age
• Glaucoma, previous eye surgery, eye injury, or eye trauma, cervical myelopathy, prior cervical spine surgery, current neoplasm, patients who have neck pain with 10 degrees active extension.

Sponsors & Collaborators

• West Virginia University: lead

Related Publications (4)

• 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.

  PMID: 15385367 BACKGROUND

• 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.

  PMID: 24456677 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.

  PMID: 17978659 BACKGROUND

• 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.

  PMID: 26582611 DERIVED

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr. Sanford Emery
• Organization: West Virginia University

semery@hsc.wvu.edu

304-293-1170

Study Officials

• Sanford E Emery, MD, MBA

  West Virginia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chairman WVU Department of Orthopaedics

Study Record Dates

• First Submitted: January 8, 2015
• First Posted: January 19, 2015
• Study Start: July 1, 2008
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: February 24, 2016
• Results First Posted: February 24, 2016

Record last verified: 2016-01

Data Sharing

• IPD Sharing: Will not share