Objectives
Primary objectives
1. To compare the laryngoscopic view
between Miller and Macintosh blades in adults.
2. To compare the ease of tracheal
intubation between Miller and Macintosh blades in adults.
Secondary objectives
1. To compare the haemodynamic stress
response to laryngoscopy and tracheal intubation between Miller and Macintosh
blades
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: Randomised control trial
Study period: 12 months (August 2022 to July
2023)
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
ï‚· Patients
aged 18-60 years.
ï‚· Patients
with ASA class I and class II.
ï‚· Patients
willing to participate in the study with informed consent.
Exclusion
Criteria
ï‚· Systemic
hypertension
ï‚· Morbid
obesity(Body Mass Index > 30)
ï‚· Coronary
artery disease
ï‚· H/o
cerebrovascular accidents
ï‚· Valvular
heart diseases
ï‚· 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 in whom laryngoscopy will be planned with either Miller or
Macintosh blade. 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. So study
population will include a group of 83 who will undergo laryngoscopy and
intubation with Miller blade and another group of 83 patients who will
undergo laryngoscopy and intubation with Macintosh 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-anaesthetic 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 tonsilla 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 classes based on the intubation prediction score,
patients in each class will be randomly allocated into either group MC
(patients undergoing laryngoscpy with Macintosh blade) or group ML (patients
undergoing laryngoscopy with Miller blade). The randomization for each class
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 monitor and parameters
like ECG, SpO2, non-invasive blood pressure and heart rate will be monitored.
Intravenous access will be obtained using 18G intravenous cannula. Anaesthetic
technique will be standardized. Patients will be pre-oxygenated with 100% O2
for 3 minutes using the circle system through face mask. Patient will be premedicated
with inj.midazolam 0.01mg/kg, inj.fentanyl 2mcg/kg, inj.lignocaine
hydrochloride (preservative free) 1.5mg/kg, followed by propofol 2 mg/kg over
30s given intravenously. After confirming the ease of mechanical ventilation
using circle system through face mask, inj.vecuronium 0.1 mg/kg will be administered
to facilitate endotracheal intubation. Mechanical ventilation with 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. Laryngoscopy
will then be performed by an experienced anaesthesiologist (with either Miller
or Macintosh laryngoscope blade) enabling a clear view of the vocal cords.
Macintosh laryngoscope blade will be gently introduced and
the tip of the blade will be placed in the vallecula. By lifting the
laryngoscope upward and forward, the epiglottis will be lifted indirectly
exposing the larynx.
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.
The laryngeal view
will be classified according to Cormack and Lehane.9 as follows:
· Grade
1: full view of glottis
· Grade
2: only posterior commissure 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
· 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) just before (0th minute) and 1st, 3rd,
5th, 10th, 15th, 20th minute
after laryngoscopy and intubation 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.
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