Laryngoscope Prototype Tested Against the Traditional Macintosh Blade

This study is currently recruiting participants.

Verified by Herlev Hospital, November 2006

First Received: September 18, 2006 Last Updated: December 1, 2006 History of Changes

Sponsored by:	Herlev Hospital
Information provided by:	Herlev Hospital
ClinicalTrials.gov Identifier:	NCT00378170

Purpose

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	Intervention
Anesthesia, Intravenous	Device: intubation of patients undergoing elective surgery

MedlinePlus related topics: Surgery

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Further study details as provided by Herlev Hospital:

Primary Outcome Measures:

succes rate - immediate evaluation
difficulty - immediate evaluation

Secondary Outcome Measures:

Cormack & Lehane grading
Time to intubate
Interincissor gap
vissible complication

Estimated Enrollment:	210
Study Start Date:	January 2006

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00378170

Contacts

Contact: Ulrik Grevstad, MD	+4525348390	basviola@get2net.dk
Contact: Ann Møller, MD	+4544884488	annmo@herlevhosp.kbhamt.dk

Locations

Denmark
KAS Herlev university Hospital	Recruiting
Herlev, Denmark, 2730

Sponsors and Collaborators

Herlev Hospital

Investigators

Study Director:

Ann Møller, consultant

unaffiliated

More Information

No publications provided

Study ID Numbers:	Prototype vs Macintosh
Study First Received:	September 18, 2006
Last Updated:	December 1, 2006
ClinicalTrials.gov Identifier:	NCT00378170 History of Changes
Health Authority:	Denmark: Ethics Committee

Keywords provided by Herlev Hospital:

intubation
difficulty
Macintosh
dental damage
complications

ClinicalTrials.gov processed this record on May 07, 2009