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 because the information has not been verified recently.
Verified March 2012 by Western Galilee Hospital-Nahariya.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Western Galilee Hospital-Nahariya
ClinicalTrials.gov Identifier:
NCT01567761
First received: March 29, 2012
Last updated: NA
Last verified: March 2012
History: No changes posted
  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

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Western Galilee Hospital-Nahariya
ClinicalTrials.gov Identifier: NCT01567761     History of Changes
Other Study ID Numbers: 3111
Study First Received: March 29, 2012
Last Updated: March 29, 2012
Health Authority: Israel: Ethics Commission

Keywords provided by Western Galilee Hospital-Nahariya:
IOP

Additional relevant MeSH terms:
Hypertension
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases

ClinicalTrials.gov processed this record on September 18, 2014