Laryngoscope Prototype Tested Against the Traditional Macintosh Blade

Anesthesia, Intravenous Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00378170
• Other study ID #: Prototype vs Macintosh
• Status: Recruiting
• Phase: N/A
• First received: September 18, 2006
• Last updated: December 1, 2006
• Start date: January 2006

Study information

• Verified date: November 2006
• Source: Herlev Hospital
• Contact: Ulrik Grevstad, MD
• Phone: +4525348390
• Email: basviola[@]get2net.dk
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anesthesia, Intravenous

Intervention

Device:
• intubation of patients undergoing elective surgery

Locations

Country	Name	City	State
Denmark	KAS Herlev university Hospital	Herlev

Sponsors (1)

Lead Sponsor	Collaborator
Herlev Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	succes rate - immediate evaluation
Primary	difficulty - immediate evaluation
Secondary	Cormack & Lehane grading
Secondary	Time to intubate
Secondary	Interincissor gap
Secondary	vissible complication