Comparison Airway Devices in Nasotracheal Intubation in Manikin (MGR-AR2010A1)
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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 |
- 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 ]
- 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:
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:
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:
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 |
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
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 June 17, 2013