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

Intubation Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04386356
• Other study ID #: 490/076/077
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2020
• Est. completion date: December 1, 2020

Study information

• Verified date: May 2020
• Source: B.P. Koirala Institute of Health Sciences
• Contact: Sabin Bhandari, MD
• Phone: +977-9851161225
• Email: sabin7000[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 1, 2020
• Est. primary completion date: August 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Intubation Complication
• Intubation; Difficult or Failed

Intervention

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.

Locations

Country	Name	City	State
Nepal	B P Koirala Institute of Health Sciences	Dharan Bazar	Province 1

Sponsors (1)

Lead Sponsor	Collaborator
B.P. Koirala Institute of Health Sciences

Country where clinical trial is conducted

Nepal, 

References & Publications (28)

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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 — View Citation

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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

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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 — View Citation

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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. — View Citation

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. — View Citation

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. — View Citation

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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

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* Note: There are 28 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Intubation difficulty scale (IDS) score18 for each device.	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	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	Rate of successful placement of endotracheal tube.	Successful placement will be confirmed by chest rise, auscultation, and square wave on 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	Number of optimization maneuvers required to perform tracheal intubation.	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.	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	Changes in heart rate before and immediately following intubation.	The blood pressure will be recorded before intubation and assessed again immediately after intubation, and every 5 minutes till the end of the surgery	From the randomization and before intubation to immediately following intubation and every 5 minutes till the end of surgery, upto 1 hour
Secondary	Incidence of trauma to the airway.	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.	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	Changes in systolic, diastolic and mean blood pressure before and immediately following intubation	The blood pressure will be recorded before intubation and assessed again immediately after intubation, and every 5 minutes till the end of the surgery	From the randomization and before intubation to immediately following intubation and every 5 minutes till the end of surgery, upto 1 hour
Secondary	Changes in oxygen saturation before and immediately following intubation	The oxygen saturation will be recorded before intubation and assessed again immediately after intubation, and every 5 minutes till the end of the surgery	From the randomization and before intubation to immediately following intubation and every 5 minutes till the end of surgery, upto 1 hour