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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Manuel Ángel Gómez-Ríos, Complexo Hospitalario Universitario de A Coruña
ClinicalTrials.gov Identifier:
NCT01311284
First received: March 7, 2011
Last updated: January 3, 2012
Last verified: January 2012
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Comparison of Airtraq Nasotracheal Mcgrath and Macintosh Laryngoscope in Nasotracheal Intubation: A Manikin Study

Further study details as provided by 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time visualization of the glottis [ Time Frame: Two months ] [ Designated as safety issue: No ]
  • Intubation time [ Time Frame: Two months ] [ Designated as safety issue: No ]
  • The duration of the first intubation attempt (whether successful or not) [ Time Frame: Two months ] [ Designated as safety issue: No ]
  • Number of intubation attempts. [ Time Frame: Two months ] [ Designated as safety issue: No ]
  • The success rate of placement of the endotracheal tube (ETT) in the trachea [ Time Frame: Two months ] [ Designated as safety issue: No ]
  • Cormack and Lehane Grade [ Time Frame: Two months ] [ Designated as safety issue: No ]
  • Number of operators needed [ Time Frame: Two months ] [ Designated as safety issue: No ]
  • Severity of dental trauma [ Time Frame: Two months ] [ Designated as safety issue: No ]
  • Satisfaction of the operators [ Time Frame: Two months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   23 Years to 65 Years
Genders Eligible for Study:   Both
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
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: 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
Study First Received: March 7, 2011
Last Updated: January 3, 2012
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Complexo Hospitalario Universitario de A Coruña:
Nasotracheal intubation
Macintosh laryngoscope
Airtraq
McGrath
Manikin
airway management

ClinicalTrials.gov processed this record on October 20, 2014