Intraocular Pressure During Abdominal Aortic Aneurysm (AAA) Repair
|First Received Date ICMJE||March 21, 2007|
|Last Updated Date||February 12, 2014|
|Start Date ICMJE||March 2007|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00450294 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Intraocular Pressure During Abdominal Aortic Aneurysm (AAA) Repair|
|Official Title ICMJE||The Effect of Aortic Infrarenal Clamping and Unclamping On Intraocular Pressure During Abdominal Aortic Aneurysm (AAA) Repair|
The objective of this study will be to answer a clinical question that has not already been investigated; that is, what are the effects of aortic infra-renal clamping and unclamping on intraocular pressure during Abdominal Aortic Aneurysm (AAA) repair? Depending on the results, this study may raise or alleviate concern that vascular surgery for abdominal aortic aneurysm could contribute to early perioperative exacerbation of pre-existing eye disease and increase a patient's vulnerability to developing a type of blindness known as ischemic optic neuropathy. The purpose of this observational study is to evaluate whether intraocular pressure measurements with a handheld tonometer will detect changes in intraocular pressure related to intraoperative events during aortic cross clamping and unclamping that may provide information on causes of perioperative blindness.
Perioperative blindness in nonocular surgery has gained significant clinical interest as an overwhelming complication with an increasing incidence. Initial published studies suggested a rare occurrence with an estimated postoperative visual loss of 0.002% and 0.0008% (1,2). However, retrospective reviews in spinal and cardiac surgery demonstrated higher rates of perioperative blindness; that is, between 0.2% and 0.06% respectively (3,4). The difference in published reports suggests that the true incidence is likely underestimated because of fears regarding litigation, ineffective means of reporting and extra work involved. Fortunately, numerous case reports and series in the middle to late 1990s were published; prompting the American Society of Anesthesiologists (ASA) Committee on Professional Liability to establish the ASA Postoperative Visual Loss Registry (POVL) in 1999 as a medium to collect confidential, comprehensive perioperative data on patients developing postoperative blindness.
The POVL registry, along with other case series, has demonstrated that the most common cause of visual loss is non-arteritic ischemic optic neuropathy (5,6,7). Perioperative non-arteritic ischemic optic neuropathy (ION) is a consequence of patient and surgery specific factors that results from hypoperfusion and infarction of the optic nerve head (8). Anatomical factors such as variation in the number of short posterior ciliary arteries (sPCA) supplying the optic nerve head, location of sPCA watershed zone, and small optic cup to disk ratio increase susceptibility to optic nerve ischemia (8,9). Surgery specific factors involve profound blood loss, anemia, hypotension, prone positioning and duration of surgery (5,6,7,10). The interaction of these surgical variables and patient specific anatomical factors can decrease ocular perfusion pressure (the difference between mean arterial pressure and intraocular pressure) and result in ION (11).
Based on the determinants of ocular perfusion pressure (OPP), low mean arterial pressure (MAP) and/or high intraocular pressure (IOP) can decrease OPP and lead to ION. Therefore, it is necessary to investigate changes in IOP incurred from different types of surgery that may increase vulnerability to developing ION. Normal IOP is between 12 - 20 mm Hg. Studies have been published assessing intraocular changes with prone positioning, laparoscopic surgery and cardiopulmonary bypass (12,13,14). However, there has been no literature evaluating intraocular pressure during abdominal aortic aneurysm (AAA) repair. AAA repair is a high-risk surgery associated with blood loss, hypotension and has been reported in a case series associated with ION (6). The surgery involves clamping and unclamping of the aorta to facilitate excision of the aneurysm and graft repair. Aortic cross clamping and unclamping is an intense physiologic insult affecting venous return, systemic vascular resistance, cardiac output, and acid base status. These physiologic changes are further pronounced with more proximal cross-clamping and longer duration. Because infrarenal abdominal aortic aneurysms are the most common type of AAA repair, we will be assessing IOP with patients undergoing elective infrarenal abdominal aortic reconstruction.
Infrarenal aortic cross clamping is associated with increases in venous return, central venous pressure and arterial blood pressure (15). The hemodynamic changes with infrarenal unclamping entail decreases in venous return, central venous pressure and arterial blood pressure (15). The determinants of intraocular pressure involve extraocular muscle tone, aqueous flow, choroidal blood volume and central venous pressure (16). The volume redistribution proximal to the aortic cross-clamp should cause a rise in venous pressure, increase resistance to aqueous drainage and increase choroidal blood volume thereby increasing intraocular pressure. However, after aortic unclamping, choroidal blood volume and IOP should decrease as venous return and central venous pressure decline. Therefore, our hypothesis is that IOP will be increased during aortic cross clamping and decreased following aortic unclamping.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Time Perspective: Prospective|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Non-Probability Sample|
All patients with known infrarenal abdominal aortic aneurysm for open repair will be screened through the preadmission anesthetic clinic. If they do not meet exclusion criteria and have signed informed consent for the the study, they will be enrolled to assess for changes in intraocular pressure during open abdominal aortic aneurysm repair.
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||August 2007|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years and older|
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||Canada|
|NCT Number ICMJE||NCT00450294|
|Other Study ID Numbers ICMJE||B2006:180|
|Has Data Monitoring Committee||Yes|
|Responsible Party||Amit Chopra, University of Manitoba|
|Study Sponsor ICMJE||University of Manitoba|
|Collaborators ICMJE||Not Provided|
|Information Provided By||University of Manitoba|
|Verification Date||February 2014|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP