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Clinical Trials/NCT00378170
NCT00378170UnknownNot Applicable

Laryngoscope Prototype Tested Against the Traditional Macintosh Blade

Herlev Hospital1 site in 1 country210 target enrollmentStarted: January 1, 2006Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
210
Locations
1
Primary Endpoint
succes rate - immediate evaluation

Study Overview

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

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
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

Outcomes

Primary Outcomes

succes rate - immediate evaluation

difficulty - immediate evaluation

Secondary Outcomes

  • Cormack & Lehane grading
  • Time to intubate
  • Interincissor gap
  • vissible complication

Investigators

Sponsor Class
Other

Study Sites (1)

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