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Comparison Airway Devices in Nasotracheal Intubation in Manikin (MGR-AR2010A1)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01311284
First Posted: March 9, 2011
Last Update Posted: January 5, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Manuel Ángel Gómez-Ríos, Complexo Hospitalario Universitario de A Coruña
  Purpose
Nasotracheal intubation is usually required in oral surgery to allow an unrestricted surgical approach. The standard method is generally performed using the Macintosh laryngoscope supported by Magill forceps. However, it is recommended to perform awake tracheal intubation in situations where a difficult airway is predicted, a scenario where this technique may be poorly tolerated by the patient. Although fibreoptic intubation is considered the "gold standard", sometimes it is difficult to perform and,therefore, alternatives are necessary. The hypothesis is that optical laryngoscopes as the Airtraq nasotracheal and Mcgrath can improve the time and/or success of nasotracheal intubation in a manikin.

Condition Intervention
Nasotracheal Intubation Device: Macintosh laryngoscope, Airtraq NT, Mcgrath laryngoscope Device: Macintosh laryngoscope Device: McGrath Device: Airtraq Nasotracheal

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Comparison of Airtraq Nasotracheal Mcgrath and Macintosh Laryngoscope in Nasotracheal Intubation: A Manikin Study

Further study details as provided by Manuel Ángel Gómez-Ríos, Complexo Hospitalario Universitario de A Coruña:

Primary Outcome Measures:
  • Time in seconds required for a successful intubation attempt with the Macintosh laryngoscope, Airtraq NT and Mcgrath. [ Time Frame: Two months ]

Secondary Outcome Measures:
  • Time visualization of the glottis [ Time Frame: Two months ]
  • Intubation time [ Time Frame: Two months ]
  • The duration of the first intubation attempt (whether successful or not) [ Time Frame: Two months ]
  • Number of intubation attempts. [ Time Frame: Two months ]
  • The success rate of placement of the endotracheal tube (ETT) in the trachea [ Time Frame: Two months ]
  • Cormack and Lehane Grade [ Time Frame: Two months ]
  • Number of operators needed [ Time Frame: Two months ]
  • Severity of dental trauma [ Time Frame: Two months ]
  • Satisfaction of the operators [ Time Frame: Two months ]

Enrollment: 63
Study Start Date: March 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Macintosh Device: Macintosh laryngoscope, Airtraq NT, Mcgrath laryngoscope
Each participant will use the Macintosh laryngoscope (blade No. 3), laryngoscope Airtraq NT and Mcgrath Laryngoscope under conditions of normal and difficult airway in different simulated scenarios.
Other Names:
  • Macintosh
  • Airtraq NT
  • Mcgrath
Device: Macintosh laryngoscope
intubate with the macintosh laryngoscope
Active Comparator: Mcgrath Device: Macintosh laryngoscope, Airtraq NT, Mcgrath laryngoscope
Each participant will use the Macintosh laryngoscope (blade No. 3), laryngoscope Airtraq NT and Mcgrath Laryngoscope under conditions of normal and difficult airway in different simulated scenarios.
Other Names:
  • Macintosh
  • Airtraq NT
  • Mcgrath
Device: McGrath
Intubate with McGrath device
Active Comparator: Airtraq Nasotracheal Device: Macintosh laryngoscope, Airtraq NT, Mcgrath laryngoscope
Each participant will use the Macintosh laryngoscope (blade No. 3), laryngoscope Airtraq NT and Mcgrath Laryngoscope under conditions of normal and difficult airway in different simulated scenarios.
Other Names:
  • Macintosh
  • Airtraq NT
  • Mcgrath
Device: Airtraq Nasotracheal
intubate with Airtraq Nasotracheal

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   23 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Be Component of service of anesthesiology C.H.U. A Coruña
  • Give voluntary consent to participate in the study

Exclusion Criteria:

  • Not meet the above criteria
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01311284


Locations
Spain
Complexo Hospitalario Universitario de A Coruña
A Coruña, Spain, 15004
Sponsors and Collaborators
Manuel Ángel Gómez-Ríos
  More Information

Publications:

Responsible Party: Manuel Ángel Gómez-Ríos, MD, Complexo Hospitalario Universitario de A Coruña
ClinicalTrials.gov Identifier: NCT01311284     History of Changes
Other Study ID Numbers: MGR-AR-2010-A1
First Submitted: March 7, 2011
First Posted: March 9, 2011
Last Update Posted: January 5, 2012
Last Verified: January 2012

Keywords provided by Manuel Ángel Gómez-Ríos, Complexo Hospitalario Universitario de A Coruña:
Nasotracheal intubation
Macintosh laryngoscope
Airtraq
McGrath
Manikin
airway management