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Laryngoscope Prototype Tested Against the Traditional Macintosh Blade

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2006 by Herlev Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Herlev Hospital
ClinicalTrials.gov Identifier:
NCT00378170
First received: September 18, 2006
Last updated: December 1, 2006
Last verified: November 2006
  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

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
  More Information

No publications provided

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

Keywords provided by Herlev Hospital:
intubation
difficulty
Macintosh
dental damage
complications

ClinicalTrials.gov processed this record on November 27, 2014