Clinical trial NCT04386356: A Comparative Study of Airtraq Versus Macintosh Laryngoscope for Endotracheal Intubation by First Year Resident
Official title: Airtraq Video Laryngoscope Versus Macintosh Laryngoscope for Endotracheal Intubation by First Year Anaesthesia Trainee in Nepalese Population: A Comparative Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intubation; Difficult or Failed
Intubation Complication
Keywords: Macintosh laryngoscope, Airtraq video laryngoscope
Lead sponsor: B.P. Koirala Institute of Health Sciences
Sponsor class: OTHER
First posted: 2020-05-13
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Time required for tracheal intubation.
timeFrame: 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:
measure: Intubation difficulty scale (IDS) score18 for each device.
timeFrame: 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
measure: Rate of successful placement of endotracheal tube.
timeFrame: 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
measure: Number of optimization maneuvers required to perform tracheal intubation.
timeFrame: 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
measure: Changes in heart rate before and immediately following intubation.
timeFrame: From the randomization and before intubation to immediately following intubation and every 5 minutes till the end of surgery, upto 1 hour
measure: Incidence of trauma to the airway.
timeFrame: 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
measure: Changes in systolic, diastolic and mean blood pressure before and immediately following intubation
timeFrame: From the randomization and before intubation to immediately following intubation and every 5 minutes till the end of surgery, upto 1 hour
measure: Changes in oxygen saturation before and immediately following intubation
timeFrame: From the randomization and before intubation to immediately following intubation and every 5 minutes till the end of surgery, upto 1 hour
Other outcomes:
Locations:
city: Dharān Bāzār
country: Nepal
facility: B P Koirala Institute of Health Sciences
state: Province 1
Study officials:
affiliation: Assistant Professor, Department of Anaesthesiology and Critical Care
name: Sabin Bhandari, MD
role: PRINCIPAL_INVESTIGATOR
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