Video Laryngoscope, New Intubation Device

NCT ID: NCT02095470

Last Updated: 2014-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

401 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2014-02-28

Brief Summary

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new glidoscope was tested on 401 patients

Detailed Description

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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

Conditions

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Elective Intubation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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videolaryngoscope group

video laryngoscopy was done for them

Group Type EXPERIMENTAL

video laryngoscope

Intervention Type DEVICE

newly developed innovatory device

traditional laryngoscope

comparison to active group with routine laryngoscope

Group Type PLACEBO_COMPARATOR

traditional laryngoscope

Intervention Type DEVICE

traditional way for intubation

Interventions

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video laryngoscope

newly developed innovatory device

Intervention Type DEVICE

traditional laryngoscope

traditional way for intubation

Intervention Type DEVICE

Other Intervention Names

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glidescope

Eligibility Criteria

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Inclusion Criteria

* elective operation who filled the consent

Exclusion Criteria

* poor intubation
* emergency cases
* hemodynamic derangement
Minimum Eligible Age

19 Years

Maximum Eligible Age

68 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Education Development Center, Inc.

INDUSTRY

Sponsor Role collaborator

Shiraz University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Javad Kojuri

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Shiraz Universty of Mesical Sciences

Shiraz, Fars, Iran

Site Status

Countries

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Iran

Other Identifiers

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93-4687

Identifier Type: OTHER

Identifier Source: secondary_id

93-4678

Identifier Type: -

Identifier Source: org_study_id

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