Study title

Comparison of face-to-face tracheal intubation and conventional head-end tracheal intubation using video-laryngoscope in adults.

Rationale: Endotracheal intubation is one of the basic procedures for securing the airway. Video-laryngoscopy is a reliable, faster and comfortable method of laryngoscopy and tracheal intubation and is a good substitute for direct laryngoscopy especially in difficult airway management. Airtraq is a new intubation aid to facilitate intubation in patients with normal or difficult airways. Airtraq laryngoscope with its video-assistance, can be used for endotracheal intubation by inserting the device from any relative operator-to-patient position. Several intubation positions have been described to facilitate intubation especially when there is limited access to the patient, including the straddling, inverse, face-to-face, ice-pick, claw-hammer and lying position.

The studies have shown that Airtraq video-laryngoscope is easier to use and when compared to other devices, success rate of face-to-face tracheal intubation with Airtraq is superior. However, very limited literature is available describing face-to-face tracheal intubation in patients and not enough work has been done comparing face-to-face and conventional head-end tracheal intubation using video-laryngoscope.

So, we plan to compare face-to-face tracheal intubation and conventional head-end tracheal intubation using video-laryngoscope in adults with normal airway undergoing elective surgeries under general anaesthesia.

Aim: To compare face-to-face tracheal intubation and conventional head-end tracheal intubation using video-laryngoscope in adult patients requiring tracheal intubation.

Objectives:

Primary objective is to know the time taken for successful tracheal intubation.

Secondary objectives would be to know about the Intubating conditions such as device Insertion time, glottic view according to POGO score and Cormack & Lehane grading, ease of intubation, number of intubation attempts, need for optimisation manoeuvres, incidence of failed intubation, rate of successful intubation; Changes in hemodynamic parameters such as SBP, DBP, HR, SpO₂ and Complications, if any.

Place of study: The proposed study will be conducted in Department of Anaesthesiology, Critical Care and Pain Medicine, University College of Medical Sciences & Guru Teg Bahadur Hospital, Delhi.

Study period: The duration of the study will be from November 2018 to April 2020.

Study design: After obtaining approval from the Institutional Ethics Committee, this randomized single-blind trial will be undertaken after taking written informed consent from all the participating subjects.

Sample size: Considering the variability of intubation time in face-to-face tracheal intubation of 2.46 seconds (interquartile range=10.3-18.8) with a median of 14 seconds. Assuming the same variability in head-end tracheal intubation, to estimate an absolute difference of 2 seconds in median intubation time at α=5% and power=80%, a sample of 25 patients is required in each group.

Patient selection: A total of 50 (25 in each group) adult patients of either sex posted for elective surgical procedures requiring general anaesthesia with tracheal intubation will be included in each group.

Inclusion criteria: Patients between the age group 18-60 years, belonging to ASA physical status I-II, Modified Mallampati Grade I and II, having mouth opening >3 finger breadths, thyromental distance >6 cms and BMI <30kg/m²  will be included in this study.

Exclusion criteria: Patients who do not give consent to participate in the study; patients with anticipated difficult airway or any airway tumor or prior neck or thyroid surgery; patients with history of recent upper respiratory tract infection within past 15 days, cervical spine disorders, coagulation disorders or having features of raised intracranial pressure; or full stomach patients will be excluded from this study.

Randomization and group allocation: Using a computer generated random number table, the patients will be randomly allocated to one of the two groups and tracheal intubation with Airtraq video-laryngoscope will be done accordingly.

Group F: Face-to-face tracheal intubation by Airtraq video-laryngoscope

Group H: Conventional head-end tracheal intubation by Airtraq video-laryngoscope

Outcome measures: Primary outcome measure is time taken for successful intubation. The secondary outcome measures will include intubating conditions like glottic view according to Percentage of Glottic Opening (POGO) score, Cormack and Lehane (C&L) score, ease of intubation, need for additional manoeuvres to facilitate intubation, attempts of intubation, incidence of failed intubation and hemodynamic response to laryngoscopy and intubation and complication if any.