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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2012 by Western Galilee Hospital-Nahariya.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01567761
First Posted: March 30, 2012
Last Update Posted: March 30, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Western Galilee Hospital-Nahariya
  Purpose

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.


Condition
Intra Ocular Hypertension

Study Type: Observational
Study Design: Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Western Galilee Hospital-Nahariya:

Estimated Enrollment: 50
Study Start Date: May 2012
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01567761


Contacts
Contact: Zvi Segal, M.D. 972-50-7887602 zvi.segal@naharia.health.gov.il

Sponsors and Collaborators
Western Galilee Hospital-Nahariya
  More Information

Responsible Party: Western Galilee Hospital-Nahariya
ClinicalTrials.gov Identifier: NCT01567761     History of Changes
Other Study ID Numbers: 3111
First Submitted: March 29, 2012
First Posted: March 30, 2012
Last Update Posted: March 30, 2012
Last Verified: March 2012

Keywords provided by Western Galilee Hospital-Nahariya:
IOP

Additional relevant MeSH terms:
Ocular Hypertension
Eye Diseases