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Nasotracheal IntubationMGR-AR2010A1NCT01311284

Comparison Airway Devices in Nasotracheal Intubation in Manikin

A study testing Macintosh laryngoscope, Airtraq NT, Mcgrath laryngoscope, Macintosh laryngoscope and McGrath in people with Nasotracheal Intubation, run by Manuel Ángel Gómez-Ríos at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 23 to 65 years
Conditions the study is for
Nasotracheal Intubation
What is being tested?
Macintosh laryngoscope, Airtraq NT, Mcgrath laryngoscope, Macintosh laryngoscope and McGrath
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
63 participants
Where
1 siteSpain
Study dates
Mar 2011to Dec 2011
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 23 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Not meet the above criteria

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Complexo Hospitalario Universitario de A Coruña

    A Coruña, A Coruña, 15004

Other trials in Spain

About this study

Official title: 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.

Being tested
Macintosh laryngoscope, Airtraq NT, Mcgrath laryngoscope, Macintosh laryngoscope, McGrath, Airtraq Nasotracheal
Keywords
Nasotracheal intubation, Macintosh laryngoscope, Airtraq, McGrath, Manikin, airway management

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Macintosh laryngoscope, Airtraq NT, Mcgrath laryngoscopeDevice

    Also called Macintosh, Airtraq NT, 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.

  • Macintosh laryngoscopeDevice

    intubate with the macintosh laryngoscope

  • McGrathDevice

    Intubate with McGrath device

  • Airtraq NasotrachealDevice

    intubate with Airtraq Nasotracheal

Study groups in NCT01311284
Study groupRoleWhat they receive
MacintoshActive comparatorNot described
Receives: Device: Macintosh laryngoscope, Airtraq NT, Mcgrath laryngoscope; Device: Macintosh laryngoscope
McgrathActive comparatorNot described
Receives: Device: Macintosh laryngoscope, Airtraq NT, Mcgrath laryngoscope; Device: McGrath
Airtraq NasotrachealActive comparatorNot described
Receives: Device: Macintosh laryngoscope, Airtraq NT, Mcgrath laryngoscope; Device: Airtraq Nasotracheal

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Two months

Secondary outcomes (9)

  1. Time visualization of the glottis

    Measured: Two months

  2. Intubation time

    Measured: Two months

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

    Measured: Two months

  4. Number of intubation attempts.

    Measured: Two months

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

    Measured: Two months

  6. Cormack and Lehane Grade

    Measured: Two months

  7. Number of operators needed

    Measured: Two months

  8. Severity of dental trauma

    Measured: Two months

  9. Satisfaction of the operators

    Measured: Two months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Mar 2011 (estimated)
  2. Study startMar 2011
  3. Primary completionDec 2011
  4. Study completionDec 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
63 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01311284
Sponsor's protocol ID
MGR-AR-2010-A1
Acronym
MGR-AR2010A1
Status last verified
Jan 2012
First submitted
7 Mar 2011
Last updated
5 Jan 2012
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 12603455

  • 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.

    PubMed 20890692

  • 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.

    PubMed 20958276

  • 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.

    PubMed 20528836

  • 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.

    PubMed 20422847

  • 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.

    PubMed 20357149

  • 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.

    PubMed 20337620

  • 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.

    PubMed 19522050

  • 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.

    PubMed 19512871

  • 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.

    PubMed 19032306

  • 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.

    PubMed 18211999

  • 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.

    PubMed 18211450

  • 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.

    PubMed 17585215

  • 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.

    PubMed 17042849

  • 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.

    PubMed 16792613

Questions about this trial

What is this clinical trial studying?

A study testing Macintosh laryngoscope, Airtraq NT, Mcgrath laryngoscope, Macintosh laryngoscope and McGrath in people with Nasotracheal Intubation, run by Manuel Ángel Gómez-Ríos at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time in seconds required for a successful intubation attempt with the Macintosh laryngoscope, Airtraq NT and Mcgrath. (time frame: Two months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01311284, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2012.

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