ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Videolaryngoscope on Intraocular Pressure

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.
ClinicalTrials.gov Identifier: NCT02474394
Recruitment Status : Completed
First Posted : June 17, 2015
Last Update Posted : June 26, 2015
Sponsor:
Information provided by (Responsible Party):
Tuğba Karaman, Tokat Gaziosmanpasa University

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

Condition or disease Intervention/treatment Phase
Intubation Complication Device: Mcgrath Device: Macintosh Phase 4

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  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Screening
Official Title: The Comparison of the Effects of McGrath Video Laryngoscope and the Macintosh Laryngoscope on Intraocular Pressure: A Randomized Trial
Study Start Date : February 2013
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Arm Intervention/treatment
Active Comparator: Mcgrath
The endotracheal intubation will be provided using Mcgrath series 5 video laryngoscope
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
Other Name: videolaryngoscope

Active Comparator: Macintosh
The endotracheal incubation will be provided using macintosh laryngoscope
Device: Macintosh
The patient will be intubated using Macintosh laryngoscope and the intraocular pressure of the patient will be evaluated with Tonopen XL tonometer
Other Name: Conventional Laryngoscope




Primary Outcome Measures :
  1. Intraocular pressure [ Time Frame: during laryngoscopy ]
    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.



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 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02474394


Locations
Turkey
Gaziosmanpasa University Medical School
Tokat, Turkey, 60100
Sponsors and Collaborators
Tokat Gaziosmanpasa University
Investigators
Principal Investigator: Tugba Karaman, M.D. Gaziosmanpasa University Medical School

Responsible Party: Tuğba Karaman, Assistant Professor, M.D., Tokat Gaziosmanpasa University
ClinicalTrials.gov Identifier: NCT02474394     History of Changes
Other Study ID Numbers: IOP-1
First Posted: June 17, 2015    Key Record Dates
Last Update Posted: June 26, 2015
Last Verified: June 2015