a) Study setting –Clinical setting
b) Study population: Patients admitted in SSG hospital and requiring general
anaesthesia with endotracheal intubation for planned surgeries.
c)Study duration- From October-2017 to October-2018
d)Study design- Prospective Randomized Controlled Study.
e)
Sampling and sample size:
“Airtraq versus Macintosh
laryngoscope in intubation performance in the pediatric populationâ€
Waleed Riad, Ashraf Moussa,1 and David T. Wong
Department of Anesthesia, Toronto Western Hospital, Canada.
Saudi Journal of Anaesthesia,2012
With reference to the study mentioned
above and with the help of nMaster 2.0 software, considering α error=0.05,
confidence interval=99% and power=90%, sample size comes to be 30 in each
group. We will be taking 30 patients in each group.
f) Inclusion Criteria:
1.
Patients posted for elective surgery under general anesthesia
requiring Endotracheal Intubation
2.
Age:3-12yrs
3.
Sex-male/female
4.
Mallampatti grade I & II
5.
ASA I & II
g) Exclusion Criteria:
1.
Sore
Throat
2.
URTI
(upper respiratory tract infection)
3.
The
patient suffering from any respiratory disease that might cause airway
narrowing
4.
Preexisting
laryngeal or tracheal pathology
5.
Any
lesion that could cause airway deformity due to fibrosis
6.
Anticipated
difficult airway (mouth opening of < 2cm, Mallampatti class IV, limited
neck extension, anatomical abnormality of airway)
7. Patient not willing for participation.
h) Pre-operative
Preparation
patient to be kept nil by
mouth(NBM) for minimum 6-8 hours and Secure iv line
i)Intervention and its method
•
After
thorough pre-anesthetic evaluation all the patients falling in the inclusion
criteria will be selected and informed written consent will be taken from
patient’s guardian(attached separately)
• Trolley
preparation:
Cylinders and circuits to be checked, airway equipment and drugs to be kept
ready before induction.
• After taking patient inside the
operation theatre, multipara monitor will be attached and baseline vital
parameters will be noted.
• Video
laryngoscope preparation:
For Airtraq video laryngoscope,
the CMOS camera will be mounted on
it and checked by watching the image on the monitor. The tube to be used will
be lubricated with lignocaine jelly. The device will be preloaded with
appropriate size tube in tube guiding channel and ensured that tube is
sliding smoothly through the channel
Premedication:
• Inj. Glycopyrrolate 5 mcq/kg IV
(5 min before induction)
•
Inj.
Peracetamol 5 mg/kg IV (5 minutes before induction)
•
Inj.
Midazolam 0.5 mg IV (5 min before induction)
• Inj. Ondensatron 0.1 mg/kg IV (5
min. before induction)
Grouping Of Patients:
The
patients will be randomly allocated into two groups of 30 patients each using
ENVELOPE method.
1) Group- A
in which Airtraq (pediatric size)
will be used for endotracheal intubation
2) Group- M
in which conventional Macintosh
laryngoscope will be used for endotracheal intubation
Induction:
•
Preoxygenation
with 100% O2 for 3min
•
Inj.
Xylocard 1 mg/kg IV
•
Inj.
Propofol 2 mg/kg IV till loss of eye lash reflex.
• Inj. Suxamethonium Chloride 1.5-2
mg/kg IV given after check ventilation.
• intubation
done by respective devices after disappearance of
fasciculations.
All the intubation procedures will be done by Myself.(I have taken
training by doing 10 pilot cases.)
•
Inj.
Vecuronium bromide 0.1 mg/kg loading dose.
Method of Endotracheal intubation:
q
Group
A (with Airtraq)
•
Patients
head will be kept in neutral position.
•
The
Airtraq of pediatric size with pre-loaded tube will be advanced from the center
of tongue towards the glottis by viewing on the screen of the monitor kept on
the side so that it will barely lift the epiglottis with the tip of the
blade.
•
Simultaneously
with the view of glottis on monitor, tube will be advanced into the trachea
under direct observation on the video screen.
•
Selection of size of Airtraq done as per
manufactures guidelines.
Airtraq
size
|
ET
which can be used
|
Age
group
|
Pediatric
|
4,4.5,5,5.5
|
2-8 years
|
Adult small
|
6,6.5,7,7.5
|
8-15 years
|
q
Group M
(with Macintosh)
•
Patient’s head will be kept in morning
sniffing position so that oro pharyngeal and tracheal axis will come in
alignment.
•
Macintosh laryngoscope of appropriate size will be advanced from
right side of the mouth.
MAC blade
|
Age group
|
No,2
|
2-10 years
|
No.3
|
10-15 years
|
•
Blade will be approached up to base of tounge, and vallecula
will be seen.
•
Vallecula will be lifted and through the glottic opening tube
will be advanced in the trachea.
Maximum
2 attempts with the selected laryngoscope will be allowed.
Failed
intubation will be defined as an attempt in which patient could not be
intubated even with optimization maneuvers or > 120 secs required to
perform the procedures.
In case of failure, the patient will be excluded from the study.
-
Optimization
maneuvers required to perform will be assessed on a score of 0 to 2.
o
0-no
maneuvers required
o
1-external laryngeal pressure /jaw thrust
o
2-use of bougie
j)
Maintenance
Oâ‚‚+Nâ‚‚O (50:50) with sevoflurane and vecuronium bromide 0.02 mg/kg.
k) Reversal
At
the end of surgery N2O and anesthetic agent to be stopped before
10 mins and patient to be ventilated with 100% oxygen. Reversal of residual
neuromuscular block to be done, once patient starts spontaneous breathing,
with following agents-
Inj. Neostigmine - 50
mcg/kg IV
Inj. Glycopyrrolate - 10
mcg/kg IV
During this period patient will be ventilated with 100%
oxygen with fresh gas flow of 4- 6 liters/min. Patient will be extubated when
regular spontaneous breathing pattern become established and patient is able
to open the eyes on command. Patient will now shifted to post anaesthesia
care unit (PACU).
l)Monitoring
1.Intubation time: The time from first picking up the laryngoscope until the first
capnography upstroke following intubation.(considering only successful
attempt)
2. No. of attempts of device insertion (maximum 2)
3.Quality of visualization of
glottic aperture
Cormack
and Lehane grading
•
Grade I: Visualization of entire vocal cords
•
Grade II: Visualization of posterior part of the laryngeal aperture
•
Grade III: Visualization of epiglottis
•
Grade IV: No glottis structure seen
CORMACK & LEHANE GRADE
|
Group A
|
Group M
|
grade I
|
|
|
grade II
|
|
|
grade III
|
|
|
grade IV
|
|
|
4. Optimization maneuvers required for intubation like jaw thrust,
external laryngeal pressure or using a bougie.
Maneuvers required
|
Score
|
No maneuvers required
N1=0
|
|
External laryngeal pressure
/jaw thrust
N2=1
|
|
Use
of bougie
N3=2
|
|
Total (N1+N2+N3)
|
|
5.Vital parameters: Hemodynamic parameters like heart rate, mean
blood pressure, SpO2 and EtCO2 will be noted.
Parameters
(time in minutes)
|
Baseline
|
At the time of induction
|
At the time of intubation
|
1
|
2
|
3
|
4
|
5
|
10
|
20
|
30
|
60
|
90
|
120
|
Post
op
|
Pulse
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mean BP
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SpO2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EtCO2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6. Incidence of airway trauma and complications:
Traumatic intubation was deï¬ned as the presence of any of the following: blood
soiling on the tracheal tube on extubation; hoarse cry voice; and sore throat
either immediately after extubation or at 24–48 h postoperatively
intraoperative complication
Bronchospasm, Desaturation
Postoperative
complication
Sore
throat, hoarseness of voice, Coughing, Dysphagia
|