GlideScope Video Laryngoscope Versus Fiberoptic Intubation

October 26, 2016 updated by: The Cleveland Clinic

GlideScope Video Laryngoscope vs Fiberoptic Intubation

Following informed consent, patients will be randomly assigned to oral fiberoptic intubation or to oral intubation using the GlideScope Video Laryngoscope. Following the induction of general anesthesia a sealed envelope would be opened to reveal the technique to be used. A stop watch will be started at the beginning of the procedure. At the completion of intubation the stop watch will be stopped and the time recorded along with other data. Based on a sample size estimation process, it is the investigators plan to study fifty patients. The two techniques will be compared in terms of the average time needed to place the endotracheal tube and studied using a two-sided T-Test with a significance level of 0.05. To ensure comparability between the two methods, all intubators will be required to have at experienced at least 10 uses of the GlideScope and 10 uses with fiberoptic intubation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

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

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • at least 18 years old
  • scheduled for elective surgery requiring orotracheal intubation.

Exclusion Criteria:

  • known, difficult airway
  • loose teeth
  • pregnant
  • require a rapid sequence induction,
  • Body Mass Index under 30
  • unable to give consent
  • if special endotracheal tube (ETT) is needed for the case.

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Fiberoptic Intubation
Subjects will be intubated with the Fiberoptic laryngoscope.
Device: Intubation with Fiberoptic laryngoscope
Subjects will be intubated with the Fiberoptic laryngoscope.
Other Names:
  • Fiberoptic
  • laryngoscope
Active Comparator: GlideScope® Video Laryngoscope
Subjects will be intubated with the GlideScope® Video Laryngoscope.
Device: GlideScope® Video Laryngoscope
Patients will be intubated with the GlideScope® Video Laryngoscope.
Other Names:
  • GlideScope®
  • Video Laryngoscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Intubation (TTI) as Measured in Seconds
Time Frame: from start of intubation to successfully intubated up to 100 seconds
Time from insertion of either the GlideScope or in the case of fibreoptic intubation, a Williams airway (SunMed, Largo, FL, USA) into the mouth, to the time when end-tidal PCO2 exceeded 2.7 kPa (20 mmHg).
from start of intubation to successfully intubated up to 100 seconds

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intubation Difficulty Score
Time Frame: from start of intubation to successfully intubated
Intubation difficulty score is a 100-mm-long visual analogue scale (100 mm = extremely difficult);
from start of intubation to successfully intubated
Successful Intubation on 1st Attempt
Time Frame: from start of first intubation to end of first intubation attempt
from start of first intubation to end of first intubation attempt
Occurrence of Hypoxaemia
Time Frame: at 1 min prior to intubation, intubation, and 2, 4, 6, 8, and 10 min after
Arterial oxygen saturation was recorded at 1 min prior to intubation, intubation, and 2, 4, 6, 8, and 10 min after; hypoxaemia was defined as occurrence of arterial oxygen saturation <90% at any of the above measurements.
at 1 min prior to intubation, intubation, and 2, 4, 6, 8, and 10 min after
Trace Bleeding
Time Frame: Right after intubation
Trace bleeding is a binary outcome: yes or no, which is determined based on amount of post-intubation bleeding present in the suction tube
Right after intubation
Sore Throat Grade
Time Frame: On the first postoperative day
On the first postoperative day
Number of Intubation Attempts
Time Frame: from start of intubation to successfully intubated
from start of intubation to successfully intubated

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

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, 2008

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

March 9, 2010

First Submitted That Met QC Criteria

March 23, 2010

First Posted (Estimate)

March 24, 2010

Study Record Updates

Last Update Posted (Estimate)

December 20, 2016

Last Update Submitted That Met QC Criteria

October 26, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 08-079

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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