Intra Ocular HypertensionNCT01567761
The Effect of Two Different Artificial Respiration Methods on the Intraocular Pressure During Surgery Under General Anesthesia
An observational study of Intra Ocular Hypertension, run by Western Galilee Hospital-Nahariya.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Intra Ocular Hypertension
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- May 2012to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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:
Read more
- Intermittent positive pressure ventilation (IPPV)
- 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.
- Conditions
- Intra Ocular Hypertension
- Keywords
- IOP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2012 (estimated)
- Study startMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intra Ocular HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western Galilee Hospital-Nahariya
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01567761
- Sponsor's protocol ID
- 3111
- Status last verified
- Mar 2012
- First submitted
- 29 Mar 2012
- Last updated
- 30 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01567761
- Acronym / sponsor ID
- 3111
- Conditions
- Intra Ocular Hypertension
- Keywords
- IOP
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Western Galilee Hospital-NahariyaOther government
- Study start
- May 2012
- First posted
- 30 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Intermittent positive pressure ventilation (IPPV)
- 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 design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Intra Ocular Hypertension, run by Western Galilee Hospital-Nahariya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zvi Segal, M.D. (972-50-7887602, zvi.segal@naharia.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2012.