- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02474394
Effects of Videolaryngoscope on Intraocular Pressure
June 25, 2015 updated by: Tuğba Karaman, Tokat Gaziosmanpasa University
The Comparison of the Effects of McGrath Video Laryngoscope and the Macintosh Laryngoscope on Intraocular Pressure: A Randomized Trial
This study is designed to compare the effects of the McGrath Series 5 video laryngoscope and Macintosh laryngoscope on intraocular pressure during laryngoscopy.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The stability of the intraocular pressure plays an important role during ophthalmic surgery.
The systemic blood pressure, aqueous humor dynamics, choroidal blood volume, central venous pressure, extra-ocular muscle tone, and also conventional laryngoscopy affect the intraocular pressure.It was shown that the new devices for laryngoscopy, such as video laryngoscopes provide minimal hemodynamic changes when compared to direct laryngoscopes.
However there is no current data about the effects of the intubation with McGrath videolaryngoscope on intraocular pressure.
The main objective of this study to compare the effects of the McGrath Series 5 video laryngoscope and Macintosh laryngoscope on intraocular pressure during laryngoscopy.
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Tokat, Turkey, 60100
- Gaziosmanpasa University Medical School
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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 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- American society of anesthesiologist physical status I
- Non-ophthalmic elective surgery under general anesthesia
Exclusion Criteria:
- A history of pre-existing glaucoma or previous intraocular surgery
- Thyromental distance below 6cm
- Maximum mouth opening below 3cm
- Mallampati score of III or IV
- Pre-anesthetic intraocular pressure above 20 mmHg
- Number of intubation attempts more than 2
- Obstetric or laparoscopic surgery
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
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Mcgrath
The endotracheal intubation will be provided using Mcgrath series 5 video laryngoscope
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The patient will be intubated using McGrath series 5 video laryngoscope and the intraocular pressure of the patient will be evaluated with Tonopen XL tonometer
Other Names:
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Active Comparator: Macintosh
The endotracheal incubation will be provided using macintosh laryngoscope
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The patient will be intubated using Macintosh laryngoscope and the intraocular pressure of the patient will be evaluated with Tonopen XL tonometer
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intraocular pressure
Time Frame: during laryngoscopy
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The intraocular pressure measurement will be performed using a Tono-Pen XL tonometer (Reichert Inc., USA) by an ophthalmologist who is blind to the intubation device used.
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during laryngoscopy
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
February 1, 2013
Primary Completion (Actual)
June 1, 2015
Study Completion (Actual)
June 1, 2015
Study Registration Dates
First Submitted
June 15, 2015
First Submitted That Met QC Criteria
June 16, 2015
First Posted (Estimate)
June 17, 2015
Study Record Updates
Last Update Posted (Estimate)
June 26, 2015
Last Update Submitted That Met QC Criteria
June 25, 2015
Last Verified
June 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- IOP-1
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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