Laryngoscope Prototype Tested Against the Traditional Macintosh Blade

NCT ID: NCT00378170

Last Updated: 2006-12-04

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Brief Summary

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The primary objective is to evaluate a knewly developed blade (for intubating patients about to undergo surgery) and compare it to the traditional Macintosh blade

Detailed Description

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Intubation of patiens can be difficult, even impossible. It can result in different complications as damage to the teeth, lacerations of the mucosa, bleeding, fractures/luxations, hypoxia, hypercapnia, reflex bradycardia and in worst case braindamage and death.

The more difficult the intubation is the more frequent complicationrate. We believe to have developed a laryngoscopeblade that hopefully eases the intubationproces and thereby reduces the complicationrisk.

The patients included in this study is patients who are undergoing elective surgery requering intubation.

Conditions

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Anesthesia, Intravenous

Keywords

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intubation difficulty Macintosh dental damage complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Interventions

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intubation of patients undergoing elective surgery

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* age over 18
* ASA 1-III
* Patients undergoing elective surgery requering intubation at KAS Herlev

Exclusion Criteria

* Prior difficult intubation indicating awake fiberoptic intubation
* pathology in the airways predicting difficult intubation
* columna cervicalis fractures
* pregnancy
* Requirement for Rapid sequence induction
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Herlev Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Ann Møller, consultant

Role: STUDY_DIRECTOR

Locations

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KAS Herlev university Hospital

Herlev, Herlev, Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Ulrik Grevstad, MD

Role: CONTACT

Phone: +4525348390

Email: [email protected]

Ann Møller, MD

Role: CONTACT

Phone: +4544884488

Email: [email protected]

Other Identifiers

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Prototype vs Macintosh

Identifier Type: -

Identifier Source: org_study_id