Laryngoscope Prototype Tested Against the Traditional Macintosh Blade

December 1, 2006 updated by: Herlev Hospital
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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment

210

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

  • Denmark
      • Herlev, Denmark, 2730
        • Recruiting
        • KAS Herlev university Hospital

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:

  • 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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
succes rate - immediate evaluation
difficulty - immediate evaluation

Secondary Outcome Measures

Outcome Measure
Cormack & Lehane grading
Time to intubate
Interincissor gap
vissible complication

Collaborators and Investigators

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

Sponsor

Herlev Hospital

Investigators

  • Study Director: Ann Møller, consultant

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

January 1, 2006

Study Registration Dates

First Submitted

September 18, 2006

First Submitted That Met QC Criteria

September 18, 2006

First Posted (Estimate)

September 19, 2006

Study Record Updates

Last Update Posted (Estimate)

December 4, 2006

Last Update Submitted That Met QC Criteria

December 1, 2006

Last Verified

November 1, 2006

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Prototype vs Macintosh

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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