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

NCT04386356 | Unknown DMC FDA Device

• 1 other identifier: 490/076/077
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Intubation; Difficult or Failed; Intubation Complication

Keywords

Macintosh laryngoscope, Airtraq video laryngoscope

Outcome Measures

Primary Outcomes (1)

• Time required for tracheal intubation.

  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

  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

Secondary Outcomes (7)

• Intubation difficulty scale (IDS) score18 for each device.

  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

• Rate of successful placement of endotracheal tube.

  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 optimization maneuvers required to perform tracheal intubation.

  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

• Changes in heart rate before and immediately following intubation.

  From the randomization and before intubation to immediately following intubation and every 5 minutes till the end of surgery, upto 1 hour

• Incidence of trauma to the airway.

  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

Study Arms (2)

Orotracheal intubation with macintosh laryngoscope

NO INTERVENTION

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.

Orotracheal intubation with Airtraq Video Laryngoscope

ACTIVE COMPARATOR

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.

Device: Orotracheal intubation with either Macintosh laryngoscope versus Airtraq video laryngoscope

Interventions

Orotracheal intubation with either Macintosh laryngoscope versus Airtraq video laryngoscope DEVICE

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.

Orotracheal intubation with Airtraq Video Laryngoscope

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA physical status I and II
• Age group 16-65 years of either gender
• Patient requiring orotracheal intubation under general anaesthesia.

You may not qualify if:

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

Sponsors & Collaborators

• B.P. Koirala Institute of Health Sciences: lead

Study Sites (1)

B P Koirala Institute of Health Sciences

Dharān, Koshi, 56700, Nepal

RECRUITING

Related Publications (28)

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  RESULT

• 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

  RESULT

• 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.

  PMID: 21550550 RESULT

• 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.

  PMID: 21447489 RESULT

• 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.

  PMID: 23242753 RESULT

• Macintosh RR. A NEW LARYNGOSCOPE. The Lancet. 1943; 241(6233), 205.

  RESULT

• Miller RA: A new laryngoscope. Anesthesiology. 1941, 2 (3): 310-316. 10.

  RESULT

• 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.

  PMID: 24741496 RESULT

• 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.

  PMID: 20887406 RESULT

• 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: 17585215 RESULT

• 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.

  PMID: 23233395 RESULT

• 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.

  PMID: 19104167 RESULT

• 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. doi: 10.1016/j.jclinane.2006.01.002.

  PMID: 16905081 RESULT

• 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: 16792613 RESULT

• 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. doi: 10.1097/00000542-200703000-00027. No abstract available.

  PMID: 17325521 RESULT

• 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.

  PMID: 19145529 RESULT

• 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. doi: 10.1097/00000542-199712000-00005.

  PMID: 9416711 RESULT

• 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: 17042849 RESULT

• 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: 18211999 RESULT

• 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.

  PMID: 19496764 RESULT

• 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: 19512871 RESULT

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• 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.

  PMID: 21179292 RESULT

• 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.

  PMID: 19164621 RESULT

• 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.

  PMID: 21048093 RESULT

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  PMID: 6507827 RESULT

Study Officials

• Sabin Bhandari, MD

  Assistant Professor, Department of Anaesthesiology and Critical Care

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sabin Bhandari, MD

CONTACT

+977-9851161225; sabin7000@gmail.com

Balkrishna Bhattarai, MD

CONTACT

+977-9842022693; bhattaraibk@bpkihs.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: An investigator not involved in assessing the patient outcome will open the sealed envelope according to the serial number of the patient enrolled into the study.Tracheal intubation will then be performed by first year anaesthesia trainee using either Airtraq or Macintosh laryngoscope according to the randomization sequence supervised by an experienced anaesthesiologist and data recorded by an independent observer. The data will be analysed by an investigator not involved in administering anaesthesia.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: First year anaesthesia trainee are those residents in their first year of anaesthesia training and has not had any prior experience using either laryngoscope. They will be given adequate training and instructions before intubation on patients. On the day of surgery, the baseline airway variables and the baseline hemodynamic values will be recorded. An investigator not involved in assessing the patient outcome will open the sealed envelope according to the serial number of the patient enrolled into the study. Following standard induction technique of preoxygenation with 100% oxygen, injection fentanyl, injection propofol, injection veruronium and mixture of isoflurane and oxygen, tracheal intubation will then be performed by first year anaesthesia trainee using either Airtraq or Macintosh laryngoscope according to the randomization sequence supervised by an experienced anaesthesiologist and data recorded by an independent observer.

Study Record Dates

• First Submitted: April 25, 2020
• First Posted: May 13, 2020
• Study Start: February 1, 2020
• Primary Completion: August 1, 2020
• Study Completion: December 1, 2020
• Last Updated: May 27, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

NE (1)