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NCT02474394 Clinical Trial

Effects of Videolaryngoscope on Intraocular Pressure

Intubation Complication Clinical Trial

Official title:
The Comparison of the Effects of McGrath Video Laryngoscope and the Macintosh Laryngoscope on Intraocular Pressure: A Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02474394
Other study ID # IOP-1
Secondary ID
Status Completed
Phase Phase 4
First received June 15, 2015
Last updated June 25, 2015
Start date February 2013
Est. completion date June 2015

Study information
Verified date June 2015
Source Tokat Gaziosmanpasa University
Contact n/a
Is FDA regulated No
Health authority Turkey: Drug and Medical Device Institution
Study type Interventional

Clinical Trial Summary

This study is designed to compare the effects of the McGrath Series 5 video laryngoscope and Macintosh laryngoscope on intraocular pressure during laryngoscopy.

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.

Recruitment information / eligibility
Status Completed
Enrollment 80
Est. completion date June 2015
Est. primary completion date June 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Screening

Related Conditions & MeSH terms

Intervention

Device:
• Mcgrath
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
• Macintosh
The patient will be intubated using Macintosh laryngoscope and the intraocular pressure of the patient will be evaluated with Tonopen XL tonometer

Locations
Country Name City State
Turkey Gaziosmanpasa University Medical School Tokat

Sponsors (1)
Lead Sponsor Collaborator
Tokat Gaziosmanpasa University

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Intraocular pressure 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. during laryngoscopy Yes
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