Intraoperative Ocular Pressure in Lumbar Spine Fusion Patients

Not Applicable

Completed

• Conditions: Raised Ocular Pressure
• Interventions: Procedure: Head in neutral position; Procedure: Head raised 10 degrees

• Registration Number: NCT02342288
• Lead Sponsor: West Virginia University

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.

Detailed Description

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.

Study Timeline

• Study Start: 2008-07
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Study First Submitted: 2015-01-08
• Study First Submitted QC: 2015-01-16
• Study First Posted: 2015-01-19
• Results First Submitted: 2015-04-09
• Status Verified: 2016-01
• Results First Submitted QC: 2016-01-27
• Last Update Submitted: 2016-01-27
• Results First Posted: 2016-02-24
• Last Update Posted: 2016-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

Inclusion Criteria

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

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Head in neutral position	Head in neutral position	Head in neutral position
Head raised 10 degrees	Head raised 10 degrees	Head raised 10 degrees from neutral position using Gardner Wells tongs

Primary Outcome Measures

Name	Time	Method
Change in Intraoperative Ocular Pressure in Lumbar Spine Fusion Patients Head Raised 10 Degrees or Kept in Neutral Position	Prone; 5 minutes after head raised to 10 degrees; every 15 minutes; 1 hr until end of 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).

Secondary Outcome Measures

Name	Time	Method
Change and Correlations in Intraoperative Ocular Pressure in Lumbar Spine Fusion Patients	prone; every 15 minutes; 1 hr until end of surgery	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.