NCT02474394

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2013

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

June 15, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 17, 2015

Completed
Last Updated

June 26, 2015

Status Verified

June 1, 2015

Enrollment Period

2.3 years

First QC Date

June 15, 2015

Last Update Submit

June 25, 2015

Conditions

Intubation Complication

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Mcgrath

ACTIVE COMPARATOR

The endotracheal intubation will be provided using Mcgrath series 5 video laryngoscope

Device: Mcgrath

Macintosh

ACTIVE COMPARATOR

The endotracheal incubation will be provided using macintosh laryngoscope

Device: Macintosh

Interventions

McgrathDEVICE

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

Also known as: videolaryngoscope
Mcgrath
MacintoshDEVICE

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

Also known as: Conventional Laryngoscope
Macintosh

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • American society of anesthesiologist physical status I
  • Non-ophthalmic elective surgery under general anesthesia

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziosmanpasa University Medical School

Tokat Province, 60100, Turkey (Türkiye)

Location

Study Officials

  • Tugba Karaman, M.D.

    Gaziosmanpasa University Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, M.D.

Study Record Dates

First Submitted

June 15, 2015

First Posted

June 17, 2015

Study Start

February 1, 2013

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

June 26, 2015

Record last verified: 2015-06

Locations

TU(1)