- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01311284
Comparison Airway Devices in Nasotracheal Intubation in Manikin (MGR-AR2010A1)
January 3, 2012 updated by: Manuel Ángel Gómez-Ríos
Comparison of Airtraq Nasotracheal Mcgrath and Macintosh Laryngoscope in Nasotracheal Intubation: A Manikin Study
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
63
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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A Coruña, Spain, 15004
- Complexo Hospitalario Universitario de A Coruña
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
23 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Macintosh
|
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:
intubate with the macintosh laryngoscope
|
Active Comparator: Mcgrath
|
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:
Intubate with McGrath device
|
Active Comparator: Airtraq Nasotracheal
|
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:
intubate with Airtraq Nasotracheal
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time in seconds required for a successful intubation attempt with the Macintosh laryngoscope, Airtraq NT and Mcgrath.
Time Frame: Two months
|
Two months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time visualization of the glottis
Time Frame: Two months
|
Two months
|
Intubation time
Time Frame: Two months
|
Two months
|
The duration of the first intubation attempt (whether successful or not)
Time Frame: Two months
|
Two months
|
Number of intubation attempts.
Time Frame: Two months
|
Two months
|
The success rate of placement of the endotracheal tube (ETT) in the trachea
Time Frame: Two months
|
Two months
|
Cormack and Lehane Grade
Time Frame: Two months
|
Two months
|
Number of operators needed
Time Frame: Two months
|
Two months
|
Severity of dental trauma
Time Frame: Two months
|
Two months
|
Satisfaction of the operators
Time Frame: Two months
|
Two months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Maassen R, Lee R, Hermans B, Marcus M, van Zundert A. A comparison of three videolaryngoscopes: the Macintosh laryngoscope blade reduces, but does not replace, routine stylet use for intubation in morbidly obese patients. Anesth Analg. 2009 Nov;109(5):1560-5. doi: 10.1213/ANE.0b013e3181b7303a. Epub 2009 Aug 27.
- Maharaj CH, Higgins BD, Harte BH, Laffey JG. Evaluation of intubation using the Airtraq or Macintosh laryngoscope by anaesthetists in easy and simulated difficult laryngoscopy--a manikin study. Anaesthesia. 2006 May;61(5):469-77. doi: 10.1111/j.1365-2044.2006.04547.x.
- Turkstra TP, Pelz DM, Jones PM. Cervical spine motion: a fluoroscopic comparison of the AirTraq Laryngoscope versus the Macintosh laryngoscope. Anesthesiology. 2009 Jul;111(1):97-101. doi: 10.1097/ALN.0b013e3181a8649f.
- Hall CE, Shutt LE. Nasotracheal intubation for head and neck surgery. Anaesthesia. 2003 Mar;58(3):249-56. doi: 10.1046/j.1365-2044.2003.03034.x.
- Liu L, Tanigawa K, Kusunoki S, Tamura T, Ota K, Yamaga S, Kida Y, Otani T, Sadamori T, Takeda T, Iwasaki Y, Hirohashi N. Tracheal intubation of a difficult airway using Airway Scope, Airtraq, and Macintosh laryngoscope: a comparative manikin study of inexperienced personnel. Anesth Analg. 2010 Apr 1;110(4):1049-55. doi: 10.1213/ANE.0b013e3181d2aad7.
- Maharaj CH, O'Croinin D, Curley G, Harte BH, Laffey JG. A comparison of tracheal intubation using the Airtraq or the Macintosh laryngoscope in routine airway management: A randomised, controlled clinical trial. Anaesthesia. 2006 Nov;61(11):1093-9. doi: 10.1111/j.1365-2044.2006.04819.x.
- Savoldelli GL, Schiffer E, Abegg C, Baeriswyl V, Clergue F, Waeber JL. Learning curves of the Glidescope, the McGrath and the Airtraq laryngoscopes: a manikin study. Eur J Anaesthesiol. 2009 Jul;26(7):554-8. doi: 10.1097/eja.0b013e3283269ff4.
- Maharaj CH, Costello JF, Harte BH, Laffey JG. Evaluation of the Airtraq and Macintosh laryngoscopes in patients at increased risk for difficult tracheal intubation. Anaesthesia. 2008 Feb;63(2):182-8. doi: 10.1111/j.1365-2044.2007.05316.x.
- Gomez-Rios MA, Serradilla LN. Use of the Airtraq(R) optical laryngoscope for nasotracheal intubation in predicted difficult airway management in oral surgery. Can J Anaesth. 2010 Dec;57(12):1136-7. doi: 10.1007/s12630-010-9390-5. Epub 2010 Oct 2. No abstract available.
- Lewis AR, Hodzovic I, Whelan J, Wilkes AR, Bowler I, Whitfield R. A paramedic study comparing the use of the Airtraq, Airway Scope and Macintosh laryngoscopes in simulated prehospital airway scenarios. Anaesthesia. 2010 Dec;65(12):1187-93. doi: 10.1111/j.1365-2044.2010.06514.x. Epub 2010 Oct 19.
- Ueshima H, Asai T. Tracheal intubation in daylight and in the dark: a randomised comparison of the Airway Scope, Airtraq, and Macintosh laryngoscope in a manikin. Anaesthesia. 2010 Jul;65(7):684-7. doi: 10.1111/j.1365-2044.2010.06366.x. Epub 2010 May 28.
- Lopez-Negrete IL, Salinas Aguirre U, Castrillo Villan JL, Rodriguez Delgado T, Colomino Alumbreros J, Aguilera Celorrio L. [Comparison of the view of the glottic opening through Macintosh and AirTraq laryngoscopes in patients undergoing scheduled surgery]. Rev Esp Anestesiol Reanim. 2010 Mar;57(3):147-52. doi: 10.1016/s0034-9356(10)70189-4. Spanish.
- McElwain J, Malik MA, Harte BH, Flynn NM, Laffey JG. Comparison of the C-MAC videolaryngoscope with the Macintosh, Glidescope, and Airtraq laryngoscopes in easy and difficult laryngoscopy scenarios in manikins. Anaesthesia. 2010 May;65(5):483-9. doi: 10.1111/j.1365-2044.2010.06307.x. Epub 2010 Mar 19.
- Savoldelli GL, Schiffer E, Abegg C, Baeriswyl V, Clergue F, Waeber JL. Comparison of the Glidescope, the McGrath, the Airtraq and the Macintosh laryngoscopes in simulated difficult airways*. Anaesthesia. 2008 Dec;63(12):1358-64. doi: 10.1111/j.1365-2044.2008.05653.x.
- Ndoko SK, Amathieu R, Tual L, Polliand C, Kamoun W, El Housseini L, Champault G, Dhonneur G. Tracheal intubation of morbidly obese patients: a randomized trial comparing performance of Macintosh and Airtraq laryngoscopes. Br J Anaesth. 2008 Feb;100(2):263-8. doi: 10.1093/bja/aem346.
- Maharaj CH, Buckley E, Harte BH, Laffey JG. Endotracheal intubation in patients with cervical spine immobilization: a comparison of macintosh and airtraq laryngoscopes. Anesthesiology. 2007 Jul;107(1):53-9. doi: 10.1097/01.anes.0000267529.71756.f0.
- Maharaj CH, Costello JF, Higgins BD, Harte BH, Laffey JG. Learning and performance of tracheal intubation by novice personnel: a comparison of the Airtraq and Macintosh laryngoscope. Anaesthesia. 2006 Jul;61(7):671-7. doi: 10.1111/j.1365-2044.2006.04653.x.
- Maharaj CH, Costello J, Higgins BD, Harte BH, Laffey JG. Retention of tracheal intubation skills by novice personnel: a comparison of the Airtraq and Macintosh laryngoscopes. Anaesthesia. 2007 Mar;62(3):272-8. doi: 10.1111/j.1365-2044.2007.04938.x.
- Ray DC, Billington C, Kearns PK, Kirkbride R, Mackintosh K, Reeve CS, Robinson N, Stewart CJ, Trudeau T. A comparison of McGrath and Macintosh laryngoscopes in novice users: a manikin study. Anaesthesia. 2009 Nov;64(11):1207-10. doi: 10.1111/j.1365-2044.2009.06061.x.
- Walker L, Brampton W, Halai M, Hoy C, Lee E, Scott I, McLernon DJ. Randomized controlled trial of intubation with the McGrath Series 5 videolaryngoscope by inexperienced anaesthetists. Br J Anaesth. 2009 Sep;103(3):440-5. doi: 10.1093/bja/aep191. Epub 2009 Jul 15.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2011
Primary Completion (Actual)
December 1, 2011
Study Completion (Actual)
December 1, 2011
Study Registration Dates
First Submitted
March 7, 2011
First Submitted That Met QC Criteria
March 8, 2011
First Posted (Estimate)
March 9, 2011
Study Record Updates
Last Update Posted (Estimate)
January 5, 2012
Last Update Submitted That Met QC Criteria
January 3, 2012
Last Verified
January 1, 2012
More Information
Terms related to this study
Other Study ID Numbers
- MGR-AR-2010-A1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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