3. Objectives Primary objectives 1. To compare the laryngoscopic view between Miller and McCoy blades in adults. 2. To compare the ease of tracheal intubation between Miller and McCoy blades in adults. 4. Methodology Source of data: The study group comprises of patients admitted in teaching hospital of Mandya Institute of Medical Sciences, Mandya, scheduled for surgery requiring general anaesthesia with orotracheal intubation. Study setting: Department of Anaesthesiology, Mandya Institute of Medical Sciences, Mandya. Study design: Randomized control trial Study period: 12 months (May 2023 to April 2024) Sample size: 83 in each group Sample size is calculated using formula: n = (poqo+p1q1)(z 1-α/2 +z1-β/2 )2/(p1-p0)2 Based on the results of one of the previous study (Study by Yadav P et al.6), POGO scores in group A (Macintosh) and group B (Miller) was 68.2 (Po) and 86 (P1) respectively. z(1-α)/2 = 1.96 = value of standard normal distribution corresponding to a significance level of α z(1-β)/2 = 0.84 = value of the standard normal distribution corresponding to the desired level of power po = proportion of controls = 68.2 qo = (1- po) p1 = proportion of cases = 86 q1 = (1- p1) So, n = 83.4 Sample size taken for study is 166 patients, with 83 patients in each group. Sampling Method: Simple random sampling Inclusion Criteria: Patients fulfilling the following criteria  Patients aged 18-60 years.  Patients with ASA class I and class II.  Patients willing to participate in the study with informed consent. Exclusion Criteria  Systemic hypertension  Morbid obesity(Body Mass Index > 30)  Coronary artery disease  H/o cerebrovascular accidents  Valvular heart diseases  If rapid sequence induction is required Data collection: Study population will include 166 patients fulfilling our inclusion and exclusion criteria posted for surgeries under general anaesthesia. The study will be a randomized control trial. The procedure will be explained and informed consent will be obtained. Patients requiring orotracheal intubation will be randomly allocated into two groups each containing 83 patients Group I: patients undergoing laryngoscopy and intubation first with Miller blade and then with McCoy blade. Group II: patients undergoing laryngoscopy and intubation first with McCoy blade and then with Miller blade. A day prior to the planned procedure, detailed history of the patient will be taken during the pre-operative assessment visit. A thorough clinical examination will be conducted and necessary investigations will be sent and results will be noted. Based on the pre-anesthetic airway assessment, patients’ airway will be classified into different grades integrating three predictive tests. The predictive tests used will be 1) Modified Mallampati’s grading.3- Measures the relative tongue/pharyngeal size. The observer classifies the airway according to the pharyngeal structures seen: · Grade 1 = soft palate, fauces, uvula, anterior and posterior tonsillar pillars (1 point) · Grade 2 = soft palate, fauces, uvula (2 points) · Grade 3 = soft palate, base of uvula (3 points) · Grade 4 = soft palate not visible at all (4 points) 2) Atlanto-occipital joint extension.3(AOJE)- When the AOJ is extended, the angle between the erect and extended planes of the occlusal surface of the upper teeth quantitates the degree of AOJE · Grade 1 = AOJE ≥ 35° (1 point) · Grade 2 = AOJE ≥22° and < 35° (2 points) · Grade 3 = AOJE ≥ 13° and < 22° (3 points) · Grade 4 = AOJE < 13° (4 points) 3) Mandibular space.3- Includes the thyromental distance (TMD) and the horizontal length of the mandible (LM) · Grade 1 = TMD≥ 6 cm and LM ≥ 9 cm (1 point) · Grade 2 = TMD ≥ 6 cm and LM < 9 cm (2 points) · Grade 3 = TMD < 6 cm and LM ≥ 9 cm (3 points) · Grade 4 = TMD < 6 cm and LM < 9 cm (4 points). Addition of the points generates a nominal score (intubation prediction score.3) and is classified as: · Grade 1: easy intubation is predicted (3–4 points) · Grade 2: moderately difficult intubation is predicted (5–8 points) · Grade 3: difficult intubation is predicted (9–12 points) After classifying patients to different grades based on the intubation prediction score, patients in each grade will be randomly allocated into either Group I or Group II. The randomization for each group will be done using computer generated randomization table. All patients will be kept nil per oral for 6 hours before surgery and premedicated with tablet alprazolam 0.25mg and capsule omeprazole 20mg orally at bedtime. On the day of planned procedure, patients will be shifted to the operation theatre and connected to the standard monitors like Electrocardiograph (ECG), pulse oximeter, non-invasive blood pressure (NIBP) and baseline values of heart rate, blood pressure, SpO2 will be noted. Intravenous access will be obtained using 18G intravenous cannula. Anesthetic technique will be standardized. Patients will be pre-oxygenated with 100% O2 for 3 minutes using the circle system through face mask. Patients will be premedicated intravenously with midazolam 0.01mg/kg, fentanyl 2µg/kg, lignocaine hydrochloride (preservative free) 1.5mg/kg, followed by intravenous induction with propofol 2 mg/kg. After confirming the ability to mechanically ventilate the patient using circle system through face mask, intravenous vecuronium 0.1 mg/kg will be administered to facilitate endotracheal intubation. Mechanical ventilation with 100% oxygen and 1-2% Sevoflurane will be done for 3 minutes. Heart rate, systolic blood pressure, diastolic blood pressure and mean arterial pressure will be noted (value just before laryngoscopy). Laryngoscopy will then be performed by an experienced anaesthesiologist first with Miller blade in Group I or McCoy blade in Group II and patients will be intubated with appropriate size endotracheal tube. CL grade and ease of intubation will be assessed and hemodynamic parameters will be noted for 10 minutes. After 10 minutes endotracheal tube will be removed, bag and mask ventilation will be continued and intravenous Propofol will be given in titrated doses if necessary to bring the hemodynamic parameters to near baseline values. Now, laryngoscopy and intubation will be performed in the same patient for the second time with McCoy blade in Group I or with Miller blade in Group II. CL grade and ease of intubation will be assessed and hemodynamic response will be noted for 10 minutes. While performing laryngoscopy with McCoy blade, the tip will be gently introduced in the vallecula followed by upward and forward movement of the blade for visualizing the larynx. Laryngeal view will be assessed, first without using lever and then with lever and CL grade will be noted in both instances. Miller laryngoscope blade will be gently introduced and tip of the blade will be passed behind the epiglottis. By lifting the laryngoscope upward and forward, the epiglottis will be lifted directly exposing the larynx. Intubation with Miller blade will always be done using intubating stylet to straighten the endotracheal tube. The laryngeal view will be classified according to Cormack and Lehane.7 as follows: · Grade 1: full view of glottis · Grade 2a: partial view of the glottis · Grade 2b: arytenoids or posterior of the vocal cords only just visible · Grade 3: only epiglottis visible · Grade 4: no glottis structure visible The degree of difficulty with intubation will be rated as: · Grade 1- intubation easy · Grade 2- intubation requiring an increased anterior lifting force and assistance to pull the right corner of the mouth laterally to augment space · Grade 3- intubation requiring multiple attempts, BURP maneuver and stylet (use of stylet only in case of McCoy blade) · Grade 4- failure to intubate with the assigned laryngoscope Time taken for tracheal intubation will be defined as time taken from insertion of laryngoscope blade into the oral cavity to successful passage of endotracheal tube into the glottis. Heart rate, blood pressure values (systolic blood pressure, diastolic blood pressure, mean arterial pressure) and SpO2 just before (0th minute) and 1st, 3rd, 5th, 10th minute after laryngoscopy and intubation with each blade will be noted. Plan for data analysis: The collected data will be analyzed using Microsoft Excel software with SPSS trial version. Descriptive statistics {mean, standard deviation, proportions etc.}, inferential statistics {t- test (to know the difference between means), chi-square test (to know the association)}, and other relevant statistical tests will be used. |