Comparison Airway Devices in Nasotracheal Intubation in Manikin

Nasotracheal Intubation Clinical Trial

— MGR-AR2010A1  

Official title:

Comparison of Airtraq Nasotracheal Mcgrath and Macintosh Laryngoscope in Nasotracheal Intubation: A Manikin Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01311284
• Other study ID #: MGR-AR-2010-A1
• Status: Completed
• Phase: N/A
• First received: March 7, 2011
• Last updated: January 3, 2012
• Start date: March 2011
• Est. completion date: December 2011

Study information

• Verified date: January 2012
• Source: Complexo Hospitalario Universitario de A Coruña
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 23 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Nasotracheal Intubation

Intervention

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.
• Macintosh laryngoscope
intubate with the macintosh laryngoscope
• McGrath
Intubate with McGrath device
• Airtraq Nasotracheal
intubate with Airtraq Nasotracheal

Locations

Country	Name	City	State
Spain	Complexo Hospitalario Universitario de A Coruña	A Coruña

Sponsors (1)

Lead Sponsor	Collaborator
Manuel Ángel Gómez-Ríos

Country where clinical trial is conducted

Spain, 

References & Publications (20)

Gómez-Ríos MA, Serradilla LN. Use of the Airtraq® 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. — View Citation

Hall CE, Shutt LE. Nasotracheal intubation for head and neck surgery. Anaesthesia. 2003 Mar;58(3):249-56. Review. — View Citation

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. — View Citation

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. — View Citation

López-Negrete IL, Salinas Aguirre U, Castrillo Villán JL, Rodríguez 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. Spanish. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time in seconds required for a successful intubation attempt with the Macintosh laryngoscope, Airtraq NT and Mcgrath.		Two months	No
Secondary	Time visualization of the glottis		Two months	No
Secondary	Intubation time		Two months	No
Secondary	The duration of the first intubation attempt (whether successful or not)		Two months	No
Secondary	Number of intubation attempts.		Two months	No
Secondary	The success rate of placement of the endotracheal tube (ETT) in the trachea		Two months	No
Secondary	Cormack and Lehane Grade		Two months	No
Secondary	Number of operators needed		Two months	No
Secondary	Severity of dental trauma		Two months	No
Secondary	Satisfaction of the operators		Two months	No