Video Laryngoscope, New Intubation Device

March 20, 2014 updated by: Javad Kojuri, Shiraz University of Medical Sciences

Advanced Video Laryngoscope, a New Practical Intubation Device: Randomized Clinical Trial in 401 Patients

new glidoscope was tested on 401 patients

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Four hundred and one patients who were scheduled for elective operation, were randomly assigned to be intubated by direct laryngoscopy using a Macintosh blade size 3rd (DL, n=196) or intubation using the video laryngoscope (VL, n=205). Prior to intubation all patients were given a similar regimen of induction of anesthesia. The patients were then intubated, using direct laryngoscopy or the VL, by a different anesthetist during which the larynx was inspected and given a laryngoscopy score. Time to intubate, failure rate, injuries, personnel pleasure and, aspiration rate were measured

Study Type

Interventional

Enrollment (Actual)

401

Phase

  • Phase 2
  • Phase 3

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

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

19 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • elective operation who filled the consent

Exclusion Criteria:

  • poor intubation
  • emergency cases
  • hemodynamic derangement

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: videolaryngoscope group
video laryngoscopy was done for them
Device: video laryngoscope
newly developed innovatory device
Other Names:
  • glidescope
Placebo Comparator: traditional laryngoscope
comparison to active group with routine laryngoscope
Device: traditional laryngoscope
traditional way for intubation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
laryngoscopy grade
Time Frame: hospital stay (average 48 hours)
grade of laryngoscopy
hospital stay (average 48 hours)
time to intubation
Time Frame: 60 minutes
time to successful intubation in minutes
60 minutes
unsuccessful attempts
Time Frame: 60 minutes
number of failure
60 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
aspiration
Time Frame: hospital stay ( 48 hours)
clinical aspiration or radiological
hospital stay ( 48 hours)

Collaborators and Investigators

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

Sponsor

Shiraz University of Medical Sciences

Collaborators

Education Development Center, Inc.

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, 2013

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

March 15, 2014

First Submitted That Met QC Criteria

March 20, 2014

First Posted (Estimate)

March 24, 2014

Study Record Updates

Last Update Posted (Estimate)

March 24, 2014

Last Update Submitted That Met QC Criteria

March 20, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 93-4678
  • 93-4687 (Other Identifier: shiraz university o medical sciences)

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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