A Comparative Study of Airtraq Versus Macintosh Laryngoscope for Endotracheal Intubation by First Year Resident

Overview

This study evaluates the learning and performance of tracheal intubation by first year anaesthesia trainee in Nepalese population using either Airtraq or Macintosh laryngoscopes.

Full Title of Study: “Airtraq Video Laryngoscope Versus Macintosh Laryngoscope for Endotracheal Intubation by First Year Anaesthesia Trainee in Nepalese Population: A Comparative Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Health Services Research
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: August 1, 2020

Detailed Description

The airway is primarily a conduit for air to reach the lungs. Maintaining a stable, patent airway is a fundamental element of safe perioperative care for all anesthesiologists. Though maintaining airway patency seems conceptually straightforward, a wide variety of clinical circumstances, patients, and tools can make the task of ensuring a stable, open airway under all clinical conditions extremely challenging. In spite of endotracheal intubation being a lifesaving skill, problems like delayed intubation, misplaced tracheal tube, or airway trauma are frequently encountered, and can cause death or hypoxic brain damage. The magnitude of problems during airway management constitute 17% of anaesthesia closed claims in UK, with difficult intubation being the most common at a rate of 5%.The American Society of Anesthesiologists' Closed Claims Project (ASACCP) reports that though the proportion of claims for respiratory complications decreased from 34% in the 1970s to 15% in the 1990s, the 'big three' (inadequate ventilation, oesophageal intubation, and difficult tracheal intubation) still accounted for >50% of claims leading to death or permanent brain damage. Direct laryngoscopy (DL) remains the gold standard technique for securing the airway. Successful DL involves the creation of a new (non-anatomic) visual axis, through maximal alignment of the axes of the oral and pharyngeal cavities and displacement of the tongue that requires manipulations of head, neck and larynx and other stressful movements. These manipulations of the airway have numerous adverse implications including significant hemodynamic disturbances, cervical instability, injury to oral and pharyngeal tissues, and dental damage. It is thus, a complicated technical skill with a variable learning curve and requires regular training, experience, and practice to acquire and maintain. The video laryngoscope (VL) is a recently developed device with a camera and light source on the tip of its blade that provides indirect glottic view. The Airtraq laryngoscope is a recently developed video laryngoscope. It has an anatomically shaped blade which contains two parallel channels, one, the guiding channel, for the insertion of the endotracheal tube (ETT) and the other, the optical channel, containing a series of lenses, prisms, and mirrors that transfer the image from the illuminated tip to a proximal viewfinder, giving a high-quality wide-angle view of the glottis and surrounding structures. As compared to DL, Airtraq VL requires the application of lesser force to the base of the tongue and is thus less likely to stimulate stress response and induce local tissue injury, produces less cervical movement, and has a faster learning curve relative to DL. It has also been demonstrated to be beneficial in the difficult airway scenario, when compared with the Macintosh laryngoscope, by reducing the number of failed intubations, the duration of intubation attempts and the amount of airway manipulation required, making them suitable for use by medical personnel who intubate infrequently. The purpose of this study is to evaluate learning and performance of tracheal intubation by first year anaesthesia trainee using either Airtraq VL or Macintosh laryngoscopes.

Interventions

  • Device: Orotracheal intubation with either Macintosh laryngoscope versus Airtraq video laryngoscope
    • Tracheal intubation will be performed by first year anaesthesia trainee using either Macintosh laryngoscope or Airtraq video laryngoscope according to the randomization sequence supervised by an experienced anaesthesiologist and data recorded by an independent observer on one group of patients.

Arms, Groups and Cohorts

  • No Intervention: Orotracheal intubation with macintosh laryngoscope
    • Following standard intubation protocol, tracheal intubation will be performed by first year anaesthesia trainee using Macintosh laryngoscope according to the randomization sequence supervised by an experienced anaesthesiologist and data recorded by an independent observer on one group of patients. Duration of intubation attempt, failed intubation, optimization maneuvers required to perform tracheal intubation, glottic view according to the Cormack and Lehane grading will be evaluated. Similarly, the maximum fall in oxygen saturation during intubation, HR, SBP and DBP will be documented immediately following intubation and then every 5 minutes till the end of surgery. The occurrence of minor complications (visible trauma to lip or oral mucosa, and presence of blood on laryngoscope blade), and the postoperative sore throat and hoarseness will be evaluated at the end of surgery in the postoperative recovery room.
  • Active Comparator: Orotracheal intubation with Airtraq Video Laryngoscope
    • Following standard intubation protocol, tracheal intubation will be performed by first year anaesthesia trainee using Airtraq video laryngoscope according to the randomization sequence supervised by an experienced anaesthesiologist and data recorded by an independent observer on one group of patients. Duration of intubation attempt, failed intubation, optimization maneuvers required to perform tracheal intubation, glottic view according to the Cormack and Lehane grading will be evaluated. Similarly, the maximum fall in oxygen saturation during intubation, HR, SBP and DBP will be documented immediately following intubation and then every 5 minutes till the end of surgery. The occurrence of minor complications (visible trauma to lip or oral mucosa, and presence of blood on laryngoscope blade), and the postoperative sore throat and hoarseness will be evaluated at the end of surgery in the postoperative recovery room.

Clinical Trial Outcome Measures

Primary Measures

  • Time required for tracheal intubation.
    • Time Frame: From the time of randomization and insertion of the blade of the laryngoscope between the dental arches until the endotracheal tube is placed through the vocal cords upto start of surgery, assessed upto 15 minutes
    • Duration of intubation attempt will be defined as the time elapsed from insertion of the blade of laryngoscope between the dental arches until the endotracheal tube is placed through the vocal cords and confirmed by chest rise, auscultation, and square wave capnography

Secondary Measures

  • Intubation difficulty scale (IDS) score18 for each device.
    • Time Frame: From the time of randomization and insertion of the blade of the laryngoscope between the dental arches until the endotracheal tube is placed through the vocal cords upto start of surgery, assessed upto 15 minutes
    • Number of attempts >1: N1; Each additional attempts add 1 point Number of operators >1: N2; Each additional operators add 1 point Number of alternative techniques: N3; Each techniques add 1 point Cormack Lehane grade: N4; 0 if successful blind intubation; 1 if grade at first attempt is 1 Lifting force required : N5; 0 if normal force required; 1 if increased force required Laryngeal pressure : N6; 0 if not applied; 1 if applied Vocal cord mobility : N7; 0 if abduction 1 if adduction Total IDS : Sum of scores = N1+N2+N3+N4+N5+N6+N7
  • Rate of successful placement of endotracheal tube.
    • Time Frame: From the time of randomization and insertion of the blade of the laryngoscope between the dental arches until the endotracheal tube is placed through the vocal cords upto start of surgery, assessed upto 15 minutes
    • Successful placement will be confirmed by chest rise, auscultation, and square wave on capnography.
  • Number of optimization maneuvers required to perform tracheal intubation.
    • Time Frame: From the time of randomization and insertion of the blade of the laryngoscope between the dental arches until the endotracheal tube is placed through the vocal cords upto start of surgery, assessed upto 15 minutes
    • Optimization maneuvers required to perform tracheal intubation will be assessed on a score of 0 to 2: 0. No maneuvers required. External laryngeal pressure. Use of stylet.
  • Changes in heart rate before and immediately following intubation.
    • Time Frame: From the randomization and before intubation to immediately following intubation and every 5 minutes till the end of surgery, upto 1 hour
    • The blood pressure will be recorded before intubation and assessed again immediately after intubation, and every 5 minutes till the end of the surgery
  • Incidence of trauma to the airway.
    • Time Frame: From the time of randomization and insertion of the blade of the laryngoscope between the dental arches until the endotracheal tube is placed through the vocal cords upto start of surgery, assessed upto 15 minutes
    • The occurrence of minor complications (visible trauma to lip or oral mucosa, and presence of blood on laryngoscope blade), and the postoperative sore throat and hoarseness will be evaluated at the end of surgery in the postoperative recovery room.
  • Changes in systolic, diastolic and mean blood pressure before and immediately following intubation
    • Time Frame: From the randomization and before intubation to immediately following intubation and every 5 minutes till the end of surgery, upto 1 hour
    • The blood pressure will be recorded before intubation and assessed again immediately after intubation, and every 5 minutes till the end of the surgery
  • Changes in oxygen saturation before and immediately following intubation
    • Time Frame: From the randomization and before intubation to immediately following intubation and every 5 minutes till the end of surgery, upto 1 hour
    • The oxygen saturation will be recorded before intubation and assessed again immediately after intubation, and every 5 minutes till the end of the surgery

Participating in This Clinical Trial

Inclusion Criteria

1. ASA physical status I and II 2. Age group 16-65 years of either gender 3. Patient requiring orotracheal intubation under general anaesthesia. Exclusion Criteria:

1. Patient having respiratory tract (oropharynx, larynx) pathology, 2. Patient with predicted difficult airway (such as mouth opening <2 cm), 3. Patient having gastroesophageal reflux disease, hiatus hernia, and pregnancy.

Gender Eligibility: All

Minimum Age: 16 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • B.P. Koirala Institute of Health Sciences
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dr Sabin Bhandari, Assistant Professor – B.P. Koirala Institute of Health Sciences
  • Overall Official(s)
    • Sabin Bhandari, MD, Principal Investigator, Assistant Professor, Department of Anaesthesiology and Critical Care
  • Overall Contact(s)
    • Sabin Bhandari, MD, +977-9851161225, sabin7000@gmail.com

References

Rosenblatt WH, Sukhupragaran W. Airway management. In: Barash PG, Cullen BF, Stoelting RK, Cahalan MK, Stock MC, Ortega R, editors. Clinical Anesthesia. 7th ed. Philadelphia, PA: Wolters Kluwer Health/Lippincott Williams & Wilkins; 2013. p. 774.

Berry JM, Harvey S. Laryngoscopic Orotracheal and Nasotracheal Intubation. In: Benumof and Hagberg"s Airway Management; Hagberg CA, Gabel JC, editors, 3rd ed. Philadelphia, PA: Elsevier/Saunders; 2013. p.346-347.

Citations Reporting on Results

Zafirova Z, Tung A. The Difficult Airway: Definitions and Algorithms. In: Glick DB, Cooper RM, Ovassapian A, editors. The difficult airway. New York: Springer; 2013. p.1.

Woodall NM, Benger JR, Harper JS, et al. Airway management complications during anaesthesia, in intensive care units and in emergency departments in the UK. Trends in Anaesthesia and Critical Care. 2012; 2(2), 58-64. doi:10.1016/j.tacc.2012.02.005

Metzner J, Posner KL, Lam MS, Domino KB. Closed claims' analysis. Best Pract Res Clin Anaesthesiol. 2011 Jun;25(2):263-76. doi: 10.1016/j.bpa.2011.02.007. Review.

Cook TM, Woodall N, Harper J, Benger J; Fourth National Audit Project. Major complications of airway management in the UK: results of the Fourth National Audit Project of the Royal College of Anaesthetists and the Difficult Airway Society. Part 2: intensive care and emergency departments. Br J Anaesth. 2011 May;106(5):632-42. doi: 10.1093/bja/aer059. Epub 2011 Mar 29.

Cook TM, MacDougall-Davis SR. Complications and failure of airway management. Br J Anaesth. 2012 Dec;109 Suppl 1:i68-i85. doi: 10.1093/bja/aes393. Review.

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Chemsian R, Bhananker S, Ramaiah R. Videolaryngoscopy. Int J Crit Illn Inj Sci. 2014 Jan;4(1):35-41. doi: 10.4103/2229-5151.128011.

Niforopoulou P, Pantazopoulos I, Demestiha T, Koudouna E, Xanthos T. Video-laryngoscopes in the adult airway management: a topical review of the literature. Acta Anaesthesiol Scand. 2010 Oct;54(9):1050-61. doi: 10.1111/j.1399-6576.2010.02285.x. Epub 2010 Jul 28. Review.

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.

Paolini JB, Donati F, Drolet P. Review article: video-laryngoscopy: another tool for difficult intubation or a new paradigm in airway management? Can J Anaesth. 2013 Feb;60(2):184-91. doi: 10.1007/s12630-012-9859-5. Epub 2012 Dec 12. Review.

Nouruzi-Sedeh P, Schumann M, Groeben H. Laryngoscopy via Macintosh blade versus GlideScope: success rate and time for endotracheal intubation in untrained medical personnel. Anesthesiology. 2009 Jan;110(1):32-7. doi: 10.1097/ALN.0b013e318190b6a7.

Kaplan MB, Hagberg CA, Ward DS, Brambrink A, Chhibber AK, Heidegger T, Lozada L, Ovassapian A, Parsons D, Ramsay J, Wilhelm W, Zwissler B, Gerig HJ, Hofstetter C, Karan S, Kreisler N, Pousman RM, Thierbach A, Wrobel M, Berci G. Comparison of direct and video-assisted views of the larynx during routine intubation. J Clin Anesth. 2006 Aug;18(5):357-62.

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.

Dhonneur G, Ndoko S, Amathieu R, Housseini LE, Poncelet C, Tual L. Tracheal intubation using the Airtraq in morbid obese patients undergoing emergency cesarean delivery. Anesthesiology. 2007 Mar;106(3):629-30.

Nowicki TA, Suozzi JC, Dziedzic M, Kamin R, Donahue S, Robinson K. Comparison of use of the the Airtraq with direct laryngoscopy by paramedics in the simulated airway. Prehosp Emerg Care. 2009 Jan-Mar;13(1):75-80. doi: 10.1080/10903120802471881.

Adnet F, Borron SW, Racine SX, Clemessy JL, Fournier JL, Plaisance P, Lapandry C. The intubation difficulty scale (IDS): proposal and evaluation of a new score characterizing the complexity of endotracheal intubation. Anesthesiology. 1997 Dec;87(6):1290-7.

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.

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.

Malin E, Montblanc Jd, Ynineb Y, Marret E, Bonnet F. Performance of the Airtraq laryngoscope after failed conventional tracheal intubation: a case series. Acta Anaesthesiol Scand. 2009 Aug;53(7):858-63. doi: 10.1111/j.1399-6576.2009.02011.x. Epub 2009 Jun 3.

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.

Chalkeidis O, Kotsovolis G, Kalakonas A, Filippidou M, Triantafyllou C, Vaikos D, Koutsioumpas E. A comparison between the Airtraq and Macintosh laryngoscopes for routine airway management by experienced anesthesiologists: a randomized clinical trial. Acta Anaesthesiol Taiwan. 2010 Mar;48(1):15-20. doi: 10.1016/S1875-4597(10)60004-5.

Koh JC, Lee JS, Lee YW, Chang CH. Comparison of the laryngeal view during intubation using Airtraq and Macintosh laryngoscopes in patients with cervical spine immobilization and mouth opening limitation. Korean J Anesthesiol. 2010 Nov;59(5):314-8. doi: 10.4097/kjae.2010.59.5.314. Epub 2010 Nov 25.

Hirabayashi Y, Seo N. Airtraq optical laryngoscope: tracheal intubation by novice laryngoscopists. Emerg Med J. 2009 Feb;26(2):112-3. doi: 10.1136/emj.2008.059659.

Di Marco P, Scattoni L, Spinoglio A, Luzi M, Canneti A, Pietropaoli P, Reale C. Learning curves of the Airtraq and the Macintosh laryngoscopes for tracheal intubation by novice laryngoscopists: a clinical study. Anesth Analg. 2011 Jan;112(1):122-5. doi: 10.1213/ANE.0b013e3182005ef0. Epub 2010 Nov 3.

Cormack RS, Lehane J. Difficult tracheal intubation in obstetrics. Anaesthesia. 1984 Nov;39(11):1105-11.

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