The Effect of Two Different Artificial Respiration Methods on the Intraocular Pressure During Surgery Under General Anesthesia

March 29, 2012 updated by: Western Galilee Hospital-Nahariya

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:

  1. Intermittent positive pressure ventilation (IPPV)
  2. High frequency jet ventilation (HFJV)

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.

Exclusion Criteria:

  • Patients who are unable to provide an Informed Consent
  • Patients suffering from any eye disease
  • Patients with corneal thickness less than 450 microns or more than 600 microns
  • Smokers
  • Patients with pulmonary disease restrictive or obstructive
  • Patients using bronchodilator

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

  • Patients aged 18 - 40
  • Patients candidates to elective orthopedic surgery in the limbs
  • Patients do not suffer from general diseases that restrict their daily functioning.

Exclusion Criteria:

  • Patients who are unable to provide an Informed Consent
  • Patients suffering from any eye disease
  • Patients with corneal thickness less than 450 microns or more than 600 microns
  • Smokers
  • Patients with pulmonary disease restrictive or obstructive
  • Patients using bronchodilator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Western Galilee Hospital-Nahariya

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Study Registration Dates

First Submitted

March 29, 2012

First Submitted That Met QC Criteria

March 29, 2012

First Posted (ESTIMATE)

March 30, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

March 30, 2012

Last Update Submitted That Met QC Criteria

March 29, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3111

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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