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Comparison of Airtraq Versus MacIntosh Intubation Via Nasal Approach

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Kliniken Essen-Mitte.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Kliniken Essen-Mitte
ClinicalTrials.gov Identifier:
NCT00847184
First received: February 11, 2009
Last updated: February 18, 2009
Last verified: February 2009
  Purpose

Time, success rate, and number of optimising maneuvers for tracheal intubation via the nasal approach are not different when Aitraq technique is used compared to a standard MacIntosh blade.


Condition Intervention
Tracheal Intubation
Device: Intubation
Device: Airtraq

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Comparison of Airtraq vs. MacIntosh Intubation Via Nasal Approach

Further study details as provided by Kliniken Essen-Mitte:

Primary Outcome Measures:
  • Time for intubation [ Time Frame: 10 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Success rate for intubation [ Time Frame: 10 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: February 2009
Estimated Study Completion Date: November 2009
Estimated Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1. Airtraq
Intubation with the use of the Airtraq technique
Device: Airtraq
Intubation with the use of the Airtraq technique
Other Name: Aitraq, Prodol Meditec S.A., Vizcaya, Spain
Active Comparator: 2. MacIntosh
Intubation using the standard MacIntosh blade
Device: Intubation
Intubation using the standard MacIntosh blade

Detailed Description:

One hundred adult patients with an expected easy intubation and 100 patients with an expected difficult intubation are enrolled. Intubations are performed by two experienced fully boarded anesthesiologists. The design of the study is prospective and randomised.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Scheduled for nasal intubation
  • Adult

Exclusion Criteria:

  • Age under 18 years
  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: NCT00847184

Locations
Germany
Prof. Dr. Harald Groeben Recruiting
Essen, Germany, 45136
Contact: Harald Groeben, M.D.    ##49 201 174 31109    h.groeben@kliniken-essen-mitte.de   
Principal Investigator: Harald Groeben, M.D.         
Sponsors and Collaborators
Kliniken Essen-Mitte
Investigators
Principal Investigator: Harald Groeben, M.D. Kliniken Essen-Mitte
  More Information

Publications:
Responsible Party: Prof. Dr. Harald Groeben, Kliniken Essen-Mitte
ClinicalTrials.gov Identifier: NCT00847184     History of Changes
Other Study ID Numbers: Airtraqnasal2009
Study First Received: February 11, 2009
Last Updated: February 18, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Kliniken Essen-Mitte:
nasal intubation
Aitraq
difficult intubation

ClinicalTrials.gov processed this record on November 20, 2014