- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00378170
Laryngoscope Prototype Tested Against the Traditional Macintosh Blade
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ulrik Grevstad, MD
- Phone Number: +4525348390
- Email: basviola@get2net.dk
Study Contact Backup
- Name: Ann Møller, MD
- Phone Number: +4544884488
- Email: annmo@herlevhosp.kbhamt.dk
Study Locations
-
-
-
Herlev, Denmark, 2730
- Recruiting
- KAS Herlev university Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
succes rate - immediate evaluation
|
difficulty - immediate evaluation
|
Secondary Outcome Measures
Outcome Measure |
---|
Cormack & Lehane grading
|
Time to intubate
|
Interincissor gap
|
vissible complication
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Ann Møller, consultant
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Prototype vs Macintosh
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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