The Effect of Two Different Artificial Respiration Methods on the Intraocular Pressure During Surgery Under General Anesthesia
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|ClinicalTrials.gov Identifier: NCT01567761|
Recruitment Status : Unknown
Verified March 2012 by Western Galilee Hospital-Nahariya.
Recruitment status was: Not yet recruiting
First Posted : March 30, 2012
Last Update Posted : March 30, 2012
|First Submitted Date||March 29, 2012|
|First Posted Date||March 30, 2012|
|Last Update Posted Date||March 30, 2012|
|Study Start Date||May 2012|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures||Not Provided|
|Original Primary Outcome Measures||Not Provided|
|Change History||No Changes Posted|
|Current Secondary Outcome Measures||Not Provided|
|Original Secondary Outcome Measures||Not Provided|
|Current Other Outcome Measures||Not Provided|
|Original Other Outcome Measures||Not Provided|
|Brief Title||The Effect of Two Different Artificial Respiration Methods on the Intraocular Pressure During Surgery Under General Anesthesia|
|Official Title||A Prospective, Randomized and Double Blind Study on The Effect of Two Different Artificial Respiration Methods on the Intraocular Pressure During Surgery Under General Anesthesia|
The purpose of this study is to examine whether the intraocular pressure of operated people under general anesthesia is affected by the artificial respiration method. If it is proven that there is such influence, the findings may lead to select the best method for patients with increased intraocular pressure.
In this study, the investigators will monitor the changes observed in intraocular pressure caused during an operation in two different artificial respiration methods:
Study recruited 50 patients aged 18 - 40, candidates to elective orthopedic surgery in the limbs. These patients do not suffer from general diseases that restrict their daily functioning.
The selection of the type of surgery was done to prevent the involvement of any other factor, except the respiration method, determination of intraocular pressure.
All patients operated under general anesthesia using total intravenous anesthesia )TIVA) method.
All patients will be resuscitating half of the time of surgery using IPPV, and in the second half of surgery using HFJV.
During the surgery the IOP will be measured by an ophthalmologist who is unaware of the respiration method.
Correction will be made to the intraocular pressure values, depending on the thickness of the cornea.
The results of the measurements will be collected and the clinical significance will be reviewed by acceptable statistical methods.
|Detailed Description||Not Provided|
|Study Design||Time Perspective: Prospective|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Probability Sample|
|Study Population||Patients aged 18 - 40, candidates to elective orthopedic surgery in the limbs. These patients do not suffer from general diseases that restrict their daily functioning.|
|Condition||Intra Ocular Hypertension|
|Study Groups/Cohorts||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status||Unknown status|
|Original Estimated Enrollment||Same as current|
|Study Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Ages||18 Years to 40 Years (Adult)|
|Accepts Healthy Volunteers||Yes|
|Contacts||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries||Not Provided|
|Removed Location Countries|
|Other Study ID Numbers||3111|
|Has Data Monitoring Committee||No|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Western Galilee Hospital-Nahariya|
|Study Sponsor||Western Galilee Hospital-Nahariya|
|PRS Account||Western Galilee Hospital-Nahariya|
|Verification Date||March 2012|