Intraocular Pressure During Abdominal Aortic Aneurysm (AAA) Repair

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amit Chopra, University of Manitoba
ClinicalTrials.gov Identifier:
NCT00450294
First received: March 21, 2007
Last updated: February 12, 2014
Last verified: February 2014
Results First Received: August 26, 2009  
Study Type: Observational
Study Design: Time Perspective: Prospective
Conditions: Problem With Vision Blindness
Intraocular Pressure
Ischemic Optic Neuropathy

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Ten patients were recruited into the study after informed consent at the preoperative anesthetic clinic during a twelve month period.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Because this is a purely OBSERVATIONAL STUDY, there was no group assignment. All patients enrolled in the study were assigned to one group, that is, all patients had intraocular pressure measurements performed.

Reporting Groups
  Description
Longitudinal Study Group This study is an OBSERVATIONAL STUDY. Ten patients were enrolled to determine what happens to eye pressure during surgery for abdominal aortic aneurysm repair. Therefore, all ten patients had intraocular pressure measurements made at different event intervals to determine if there was a change in intraocular pressure compared to their baseline intraocular pressure that was taken before surgery. No active intervention was performed to the patients based on intraocular pressure as clinicians were blinded to the intraocular pressure values.Measurement of Central venous pressure at event intervals during abdominal aortic aneurysm repair. Data are presented as mean +/- standard error.

Participant Flow:   Overall Study
    Longitudinal Study Group  
STARTED     10  
COMPLETED     10  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Longitudinal Group This study is an observational longitudinal design. Ten patients were enrolled to determine what happens to eye pressure during surgery for abdominal aortic aneurysm repair. Therefore, all ten patients had intraocular pressure measurements made at different event intervals to determine if there was a change in intraocular pressure compared to their baseline intraocular pressure that was taken before surgery. No active intervention was performed to the patients based on intraocular pressure as clinicians were blinded to the intraocular pressure values.

Baseline Measures
    Longitudinal Group  
Number of Participants  
[units: participants]
  10  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     3  
>=65 years     7  
Age  
[units: years]
Mean ± Standard Deviation
  68.5  ± 11.2  
Gender  
[units: participants]
 
Female     0  
Male     10  
Region of Enrollment  
[units: participants]
 
Canada     10  
Cross Clamp Duration  
[units: min]
Mean ± Standard Deviation
  58  ± 15.3  
Preop Right Intraocular Pressure  
[units: mm Hg]
Mean ± Standard Deviation
  16.9  ± 2.6  
Preop Left Intraocular Pressure  
[units: mm HG]
Mean ± Standard Deviation
  16.7  ± 2.7  
Body mass index  
[units: kg/m2]
Mean ± Standard Deviation
  27.3  ± 3.4  
Abdominal Aortic Aneurysm Size  
[units: cm]
Mean ± Standard Deviation
  5.7  ± 0.5  
Cerebrovascular Accident (CVA)  
[units: participants]
 
HAS CVA     4  
No CVA     6  
Diabetes mellitus  
[units: participants]
 
HAS DM     10  
NO DM     0  
Hypertension  
[units: participants]
 
HAS HTN     10  
NO HTN     0  
Hyperlipidemia  
[units: participants]
 
HAS Hyperlipidemia     10  
NO Hyperlipidemia     0  
Epidural  
[units: participants]
 
Epidural     10  
NO Epidural     0  
Cumulative Crystalloid  
[units: L]
Mean ± Standard Deviation
  2.84  ± 0.13  
Vasopressor infusion  
[units: participants]
 
Vasopressor Infusion     10  
NO vasopressor infusion     0  
Mannitol  
[units: participants]
 
Received Mannitol     10  
N) Mannitol     0  
ASA Physical Status [1]
[units: participants]
 
ASA I (healthy person)     0  
ASA II (mild systemic disease)     0  
AASA III (Severe systemic disease)     10  
ASA IV (Severe systemic disease, constant threat)     0  
ASA V (moribund person)     0  
[1]

ASA physical status classification is a score given to the patient by the anesthesiologist following a preoperative assessment. It pertains to the patient's preoperative fitness. The full categorization scheme is as follows:

  1. Healthy person.
  2. Mild systemic disease.
  3. Severe systemic disease.
  4. Severe systemic disease that is a constant threat to life.
  5. A moribund person who is not expected to survive without the operation.



  Outcome Measures
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1.  Primary:   Right Intraocular Pressure During Various Event Intervals in Open Abdominal Aortic Aneurysm Surgery.   [ Time Frame: Measurements made at baseline, post induction preincision, 1 min post clamp, 5 min post clamp, 1 min pre unclamp, 1 min post unclamp, 5 min post unclamp, skin closure ]

2.  Primary:   Left Intraocular Pressure   [ Time Frame: Measurements made at baseline, post induction preincision, 1 min post clamp, 5 min post clamp, 1 min pre unclamp, 1 min post unclamp, 5 min post unclamp, skin closure ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
There were no limitations to trial during course of study.  


Results Point of Contact:  
Name/Title: Dr. Amit Chopra
Organization: Department of Anesthesia
phone: 204-880-5370
e-mail: amitchopra1@live.com


Publications:
11 Hayreh SS. Anterior ischemic optic neuropathy. Clin Neurosci 1997;4:251-63.
13 Kayacan N, Gulbin A, Akar M, Karsli B. The effect of pneumoperitoneum and head-down position on intraocular pressure. Gynaecological Endoscopy 2002;11:383-87.


Responsible Party: Amit Chopra, University of Manitoba
ClinicalTrials.gov Identifier: NCT00450294     History of Changes
Other Study ID Numbers: B2006:180
Study First Received: March 21, 2007
Results First Received: August 26, 2009
Last Updated: February 12, 2014
Health Authority: Canada: Health Canada