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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00378170
Other study ID # Prototype vs Macintosh
Secondary ID
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
Est. completion date
Est. primary completion date
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


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
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