NCT01311284

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

March 7, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 9, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

January 5, 2012

Status Verified

January 1, 2012

Enrollment Period

9 months

First QC Date

March 7, 2011

Last Update Submit

January 3, 2012

Conditions

Keywords

Nasotracheal intubationMacintosh laryngoscopeAirtraqMcGrathManikinairway management

Outcome Measures

Primary Outcomes (1)

  • Time in seconds required for a successful intubation attempt with the Macintosh laryngoscope, Airtraq NT and Mcgrath.

    Two months

Secondary Outcomes (9)

  • Time visualization of the glottis

    Two months

  • Intubation time

    Two months

  • The duration of the first intubation attempt (whether successful or not)

    Two months

  • Number of intubation attempts.

    Two months

  • The success rate of placement of the endotracheal tube (ETT) in the trachea

    Two months

  • +4 more secondary outcomes

Study Arms (3)

Macintosh

ACTIVE COMPARATOR
Device: Macintosh laryngoscope, Airtraq NT, Mcgrath laryngoscopeDevice: Macintosh laryngoscope

Mcgrath

ACTIVE COMPARATOR
Device: Macintosh laryngoscope, Airtraq NT, Mcgrath laryngoscopeDevice: McGrath

Airtraq Nasotracheal

ACTIVE COMPARATOR
Device: Macintosh laryngoscope, Airtraq NT, Mcgrath laryngoscopeDevice: Airtraq Nasotracheal

Interventions

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.

Also known as: Macintosh, Airtraq NT, Mcgrath
Airtraq NasotrachealMacintoshMcgrath

intubate with the macintosh laryngoscope

Macintosh
McGrathDEVICE

Intubate with McGrath device

Mcgrath

intubate with Airtraq Nasotracheal

Airtraq Nasotracheal

Eligibility Criteria

Age23 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Not meet the above criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Complexo Hospitalario Universitario de A Coruña

A Coruña, A Coruña, 15004, Spain

Location

Related Publications (20)

  • 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.

    PMID: 12603455BACKGROUND
  • 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.

    PMID: 20890692BACKGROUND
  • 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.

    PMID: 20958276BACKGROUND
  • 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.

    PMID: 20528836BACKGROUND
  • 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.

    PMID: 20422847BACKGROUND
  • 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.

    PMID: 20357149BACKGROUND
  • 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.

    PMID: 20337620BACKGROUND
  • 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.

    PMID: 19522050BACKGROUND
  • 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.

    PMID: 19512871BACKGROUND
  • 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.

    PMID: 19032306BACKGROUND
  • 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.

    PMID: 18211999BACKGROUND
  • 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.

    PMID: 18211450BACKGROUND
  • 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.

    PMID: 17585215BACKGROUND
  • 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.

    PMID: 17042849BACKGROUND
  • 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.

    PMID: 16792613BACKGROUND
  • 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.

    PMID: 16674623BACKGROUND
  • 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.

    PMID: 17300305BACKGROUND
  • 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.

    PMID: 19713258BACKGROUND
  • 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.

    PMID: 19825056BACKGROUND
  • 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.

    PMID: 19605408BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 7, 2011

First Posted

March 9, 2011

Study Start

March 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

January 5, 2012

Record last verified: 2012-01

Locations