Laryngoscope Prototype Tested Against the Traditional Macintosh Blade

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00378170
Recruitment Status : Unknown
Verified November 2006 by Herlev Hospital.
Recruitment status was:  Recruiting
First Posted : September 19, 2006
Last Update Posted : December 4, 2006
Information provided by:
Herlev Hospital

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Anesthesia, Intravenous Device: intubation of patients undergoing elective surgery Not Applicable

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  (Clinical Trial)
Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Prevention
Study Start Date : January 2006

Primary Outcome Measures :
  1. succes rate - immediate evaluation
  2. difficulty - immediate evaluation

Secondary Outcome Measures :
  1. Cormack & Lehane grading
  2. Time to intubate
  3. Interincissor gap
  4. vissible complication

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00378170

Contact: Ulrik Grevstad, MD +4525348390
Contact: Ann Møller, MD +4544884488

KAS Herlev university Hospital Recruiting
Herlev, Denmark, 2730
Sponsors and Collaborators
Herlev Hospital
Study Director: Ann Møller, consultant Identifier: NCT00378170     History of Changes
Other Study ID Numbers: Prototype vs Macintosh
First Posted: September 19, 2006    Key Record Dates
Last Update Posted: December 4, 2006
Last Verified: November 2006

Keywords provided by Herlev Hospital:
dental damage