NCT01271621

Brief Summary

Tracheal intubation with traditional Macintosh laryngoscope is associated with increase in intraocular pressure along with tachycardia and hypertension. These effects are not desirable in ophthalmic patients especially in patients with glaucoma. GlideScope video laryngoscope system is a new approach for laryngoscopy and tracheal intubation. It does not require a direct line of sight to the glottis when intubating with the Glidescope and as a result intubation is much less stimulating to the patient. Therefore GlideScope video laryngoscope assisted intubation could be a preferable technique for intraocular surgery offering advantages in terms of intraocular pressure and cardiovascular stability.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2010

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

June 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2010

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 7, 2011

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

October 21, 2021

Status Verified

October 1, 2021

Enrollment Period

2 years

First QC Date

November 15, 2010

Last Update Submit

October 14, 2021

Conditions

Effect of Intubation on Intraocular Pressure

Keywords

Airtraq, Intraocular pressure

Outcome Measures

Primary Outcomes (1)

  • Intraocular pressure

    one year

Study Arms (2)

Macintoch group

ACTIVE COMPARATOR

Intubation with Macintoch Laryngoscope

Device: Intubation

Glidescope

EXPERIMENTAL

Inubation by Glidescope

Device: Intubation

Interventions

IntubationDEVICE

Endotracheal intubation

GlidescopeMacintoch group

Eligibility Criteria

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

You may qualify if:

  • ASA physical status 1 or 2 with normal intra-ocular pressure.

You may not qualify if:

  • history or occurrence of difficult intubation.
  • presence of previous anterior segment pathology.
  • previous intraocular surgery.
  • patients with history of glaucoma.
  • brain pathology and other neurological disorder which might affect to their intraocular pressure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

king Khaled Eye Specialist Hospital

Riyadh, 11462, Saudi Arabia

Location

MeSH Terms

Interventions

Intubation

Intervention Hierarchy (Ancestors)

TherapeuticsInvestigative Techniques

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2010

First Posted

January 7, 2011

Study Start

June 1, 2010

Primary Completion

June 1, 2012

Study Completion

August 1, 2012

Last Updated

October 21, 2021

Record last verified: 2021-10

Locations

SA(1)