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UTILITY OF SUPRA-GLOTTIC AIRWAY DEVICE IN CRITICAL CARE UNIT
CARE UNIT.
Varsha Verma
Junior resident, Department of Anaesthesiology and Critical Care, King George's
Medical University, Shahmina road, Lucknow, U.P., 226003.
Original Research Paper
Anaesthesiology
INTRODUCTION
The I-gel is non-inatable supraglottic airway device designed for
spontaneous or intermittent positive pressure ventilation. It was
introduced into clinical practice in the United Kingdom in 2007 and is
1
made of a thermoplastic elastomer, a soft gel-like substance . It has
easier insertion and uses, minimal risk of tissue compression and no
2.
position change after insertion It has a widened, attened stem with a
rigid bite block that acts as a buccal cavity stabilizer to reduce axial
3
rotation and mal-positioning, and a port for gastric tube insertion . It is
a latex-free device, and less expensive than other Supraglottic devices
(SGD). The gold standard for denitive airway remains endotracheal
intubation, but beca use of mini mizi ng interrupti ons to c hest
compression and to maximize coronary and cerebral perfusion
pressure, supraglottic airway devices could be a good substitute. The
difcult airway society guidelines recommend using laryngeal mask
airway to secure ventilation and oxygenation after failed optimized
4
attempts at direct laryngoscopy . The use of SGD during anaesthesia
5.
for spontaneously breathing patients was also reported There are case
reports on the use of SGD during pressure-controlled ventilation in
6
ICU for short term ventilation .
This prospective randomized study planned to evaluate the feasibility
of I-Gel, a supraglottic device for short term mechanical ventilation in
ICU patients and to compare its efcacy with the endotracheal tube in
terms of haemodynamic changes, and lung mechanics. The secondary
objective was to compare complications, duration of mechanical
ventilation and duration of stay in ICU.
Method
After approval of the institutional ethics committee, this prospective
randomized controlled study was conducted in the Department of
Anesthesiology at King George Medical University from September
2016 to August 2017. Total 40 patients with the age group of 16 -65
years of either sex who required short term of mechanical ventilation
up to 3 hours such as post-operative patients, seizure disorder patients
in the postictal phase admitted in the intensive care unit were included
in the study. Any patients with signs of irreversible brain injury, end-
stage renal, cardiac, and hepatic failure, severe hypoxemia, risk of
2,
gastroesophageal reux, Body mass index more than 30 kg/m neck
pathology, predictors for difcult intubation, mouth opening less than
20 mm, APACHE score-II more than 20 were excluded from the study.
All 40 patients were equally divided (20 each) randomly in two groups
( Group A: Supraglottic device i.e. I-gel, Group B: Endotracheal tube)
using a computer-generated randomization. Allocation concealment
was done using sequentially numbered opaque sealed envelopes. All
patients in either groups were anaesthetized with inj. Fentanyl
1µgm/kg , inj. Midazolam 0.05 mg/ kg , inj. propofol 1.5 to 2.5 mg/kg
titrated to their hemodynamic status. After checking adequate bag-
mask ventilation, injection Vecuronium 0.1 mg/kg was given and
patients were ventilated for 3 minutes.
In group A, the appropriate size of I-gel was inserted with standard
technique. Then p atients were conn ected to a venti lator with
appropriate settings. A nasogastric tube was inserted in the gastric
channel of I-gel. Any patients with signicant tidal volume loss were
excluded after two attempts for correction. In group B, direct
laryngoscopy was done using a Macintosh blade size 3 or 4 and vocal
cords were visualized. An appropriate size endotracheal
tube was introduced in the trachea. Then patients were connected to a
ventilator with appropriate settings any patients who could not be
intubated in two attempts were excluded from the study.
Sedation in ICU was maintained with continuous infusion of inj.
Fentanyl 0.0 5-0 .08 microgram/kg/min. and midazolam (1 -2
microgram/kg/min.) or inj. Propofol (5-30 microgram/kg/min).
The systolic blood pressure (SBP), diastolic blood pressure (DBP),
Heart rate (HR) at baseline Peak airway pressure (PAP), Static
compliance (SC) and P/F ratio (PaO /FiO ) were recorded before
2 2
intubation or insertion of i-gel at 1 hour, 3 and after removal at 1 hour,
12 hour and 24 hours. All patients were observed for any complication
related to airways such as Dislodgment, gastric insufation/aspiration,
sore throat and laryngospasm. Patients were ventilated till condition
improved and no further mechanical ventilation required however the
7,8
duration of ventilation was limited to a maximum of 8 hours to i-gel .
If any patients required prolonged ventilation more than 8 hours then
Background: Study was designed to evaluate the feasibility of I-Gel for short term mechanical ventilation in patients
admitted in ICU and to compare with the endotracheal tube in terms of haemodynamic changes, and lung mechanics.
Methods:Total 40 patients with the age of 16 -65 years of either sex who required short term of mechanical ventilation up to 3 hours, were
randomized allocated into two groups i.e. Group A and Group B. In group A, the appropriate size of I-gel was used with standard technique. In
group B, after direct laryngoscopy an appropriate size endotracheal tube was introduced in the trachea. Blood pressure, Heart rate, Airway
pressure, Static compliance and (PaO2/FiO2) ratio and complications were recorded. Mean insertion time for i-gel and ETT was Results:
[12.53±3.2sec] and [16.60±2.4sec] respectively. We did not found any statistically signicant changes in heart rate and systolic BP while
diastolic BP was noticed to be increased with time in group A. Mean P/F ratio in both groups compared to baseline, increase with time which was
higher in Group B as compared to Group A. The mean Ppeak in both groups, increase with time and was slightly higher in Group B as compared to
Group A. Static Compliance was lower in Group B than Group A at all periods. Mean duration of ventilation and ICU stay were comparable and
not statistically signicant. For the short term ventilation i-gel can be used as safe alternative to endotracheal intubation in selected Conclusion:
patients. It requires less amount of sedation so early withdrawal can be possible and less chances of VAP and other complication of prolong
ventilation.
ABSTRACT
INDIAN JOURNAL OF APPLIED RESEARCH
1
Volume - 11 | Issue - 02 | February - 2021 | . PRINT ISSN No 2249 - 555X | DOI : 10.36106/ijar
KEYWORDS :SAD, Mechanical Ventilation, I-gel
Dr. Zia Arshad*
Additional Professor, Department Of Anaesthesiology And Critical Care, King
George's Medical University, Shahmina Road, Lucknow, U.p., 226003.*Corresponding
Author
Ram Gopal
Maurya
Senior Resident, Department Of Anaesthesiology And Critical Care, King George's
Medical University, Shahmina Road, Lucknow, U.p., 226003.
G. P. Singh
Professor, Department Of Anaesthesiology And Critical Care, King George's Medical
University, Shahmina Road, Lucknow, U.P., 226003.
2
INDIAN JOURNAL OF APPLIED RESEARCH
SAD was removed patient in group A was intubated with an
endotracheal tube of appropriate size and were excluded from the
analysis.
Sample size and Statistical Analysis
PS Power and Sample Size Calculation Software ( version 3.0, January
2009, Noderivs 3.0 United States license) were used to calculate the
sample size for the present study using the “ hemodynamic ( mean
14
change in systolic blood pressure)” as the primary outcome variable.
Considering the difference of 25 mmHg in mean change in systolic
blood pre ssu re during ex tub ati on between I ge l group an d
endotracheal with level of condence of 95%, an alpha error of .05 and
a power of 80%, we calculated sample size of 16 patients per group
using formula for non-inferiority trial for continuous data. To
compensate drop-out and non-response rate, we decided to recruit 20
patients per group.
SPSS 17.0 (SPSS Inc, Chicago, Illinois) for the window was used for
statistical analysis. Shapiro Wilk”s test was used to test the normality
of the data. Continuous data were summarized as Mean ± SE (standard
error of the mean) while categorical in frequency and %. Continuous
groups were compared by independent Student's t test. For categorical
variables Chi-square test or Fisher exact test was used. All statistical
tests were two tailed and P<0.05 was considered statistically
signicant
RESULTS:
Total 39 patients completed study and included in analysis. One
Patient was excluded from Group A as the patient required prolonged
ventilation.
Both groups were having comparable demographic characteristics
(Age, sex, weight and APACHE 2 score) (Table 1). In Group A, mean
SBP did not change (p>0.05) with its baseline at any time point. While
in Group B, patients showed signicantly higher SBP compared to
baseline. (Figure 1) In both groups, the mean DBP were higher
signicantly with respective baseline. However, it did not differ
(p>0.05) between two groups at all periods. In both groups had the
signicantly (p<0.001) lower mean HR at all periods as compared to
baseline value. However, between groups, it did not differ (p>0.05).
The P/F ratio of two groups over the periods is summarized in Table 2.
In group A, it differ and higher signicantly (p<0.001) at from 3 hr after
intubation to till end while in Group B, it differ and higher signicantly
(p<0.001) at from 1 hr after intubation to till end as compared to
respective baseline. However, at other periods, it did not (p>0.05)
differ between the two groups i.e. found to be statistically the same.
The peak airway pressure (PAP) of two groups over the periods is
summarized in figure 2. In both groups, the mean PAP increase with
time and the increase was evident slightly higher in Group B as
compared to Group A. However, it did not (p>0.05) differ between the
two groups at all periods i.e. found to be statistically the same. The
mean Static Compliance SC remains comparatively lower in Group B
than Group A at all periods (i.e. from 1 hr after intubation to at
removal) (Figure 3). In Group A, the mean SC differ and signicantly
(p<0.01 or p<0.001) higher at 3 hr after intubation and at removal as
compareto at 1 hr after intubation. In contrast, in Group B, it did not
(p>0.05) differ as compared to at 1 hr after intubation at all periods i.e.
found to be statistically the same.
The Ventilation time and ICU stay of two groups is summarized in
Table 3 and on Comparing Student's t test showed similar (p>0.05)
ventilation time and ICU stay between the two groups though it was
1.9% and 6.9% higher respectively in Group B as compared to Group
A.
The complications during ventilation and after removal of airway of
two groups are summarized in Table 4. In both groups, complications
viz. gastric insufation and dislodgement were found absent (100.0%)
in all patients. In contrast, in Group B, the laryngospasm was found
present in 1 (5.0%) patient but in Group A, it was absent (100.0%) in all
pat ien ts a nd the differ ence wa s also insign ic ant (p> 0.0 5).
Conversely, sore throat was present in 2 (10.5%) patients in Group A
while 1 (5.0%) patient in Group B but the difference did not reach
statistical signicance i.e. found to be statistically the same. In both
groups endotracheal intubation was found absent in all the patients at
all the periods, i.e. both group A and B were comparable (100.0%)
DISCUSSION
The introduction of Supraglottic Airway Devices in clinical practice
revolutionized the airway management and has been recommended for
use in maintaining airway patency as it has added advantage of
improved haemodynamic stability, reduced anaesthetic requirement
for airway tolerance, lower frequency of coughing and improved
oxygen saturation during emergence. In our study, i-gel is a relatively
new, single use, noninatable, SAD has been compared with ETT to
assess their performance in articially ventilated adult patients
,
particularly in an Intensive Care setting. Belgin Akan Deniz Erdem,
Mahinur Demet Albayrak, Esra Aksoy, Fatma Akdur, Nermin Gogus et
al report a case in which they use SAD(I-gel) They did not encounter
any problem in mechanical ventilation lasting for 48 h in PCV mode.
There ndings show that the I- gel can be used in order to obtain airway
control and thereafter maintaining mechanical ventilation in difcult
tracheal intubation cases in ICUs.
In our study demographic prole (age, sex, body weight) and
APACHE SCORE II between two groups was comparable i.e.
statistically insignicant (p>0.05). Similar result was obtained by
9
other group of investigators in large number of patients
The airway insertion and intubation were uncomplicated in all the
patients and our data showed mean insertion time for i-gel and
intubation with ETT was [12. 53±3 .2sec] a nd [16.60±2. 4sec ]
respectively. The result was statistically signicant and it was higher in
group B (ETT) than Group A (i-gel). Our observation was similar to
some previous studies such as Anjan Das et al.
We did not found any statistically signicant changes in systolic blood
pressure (SBP) while diastolic blood pressure (DBP) was noticed to be
increased with time in group A i.e. i-gel throughout study interval.
[6,9]
Similar statement was also concluded in few other studies also . But
in group B i.e. ETT, the changes were statistically signicant in both
systolic and diastolic blood pressures throughout the interval but as
compared to group A increase in SBP was statistically signicant and
higher in group B.
The changes in heart rate from baseline when compared between two
groups were statistically insignicant. However, the mean heart rate
was decreased within both the groups throughout study interval. Thus
statistically signicant changes were observed in heart rate in group A
10
and B as compared to baseline. Ismail et al did a study to measure
haemodynamic responses in 60 patients.They divided patients into
three groups receiving lma classic, i-gel, ETT and found that i-gel
provides better stability of haemodynamic system.
In this study mean P/F ratio in both groups compared to respective
baseline, increase with time which was higher in Group B as compared
to Group A. In Group A, it is different and signicantly higher
(p<0.001) at 1 hr after insertion. While in Group B, it was highly
signicant (p<0.001) at 3 hr after intubation. However, at other
periods, it did not differ between the two groups i.e. found to be
statistically the same (p>0.05). As evident from above mentioned
observation, after mechanical ventilation both groups showed
11
improvement in oxygenation. Jaranzadeh et al. 2016 studied role of
ventilation mode using a laryngeal mask airway during gynecological
laparoscopy on lung mechanics, hemodynamic response and blood gas
analysis. They found that PaO was signicantly higher after 10 and 15
2
min in VCV (volume control ventilation) group compared to PCV
(pres sure co ntr ol venti latio n) group (p =0.00 5 a nd p=0.0 3,
respectively).The end tidal CO showed signicant increase after 10
2
and 15 min in VCV compared to PCV group.
On comparison of the mean peak airway pressure (PAP) in both
groups, increase with time and was slightly higher in Group B as
compared to Group A. However, it did not (p>0.05) differ between the
two groups at all periods i.e. found to be statistically insgnicant.
12
Sidiqui et al. found Average PAP were 16.21 ± 1.78 cm H O which
2
were adequate for controlled ventilation.
13
D. Olzdamar et al. 2010 compared classical LMA with ET tube,
change in PAP, SPO , and ET CO levels was Insignicant among
2 2
groups.
In our study static Compliance (SC) was lower in Group B than Group
A at all periods (i.e. from 1 hr after intubation to removal). In i-gel
group SC was signicantly (p<0.01) higher at 3 hr and at removal as
compared to at 1 hr.Conversely, between groups, compliance was
14
signicantly lower (p<0.01) in Group B. Russo et al compared i-gel®,
Volume - 11 | Issue - 02 | February - 2021 | . PRINT ISSN No 2249 - 555X | DOI : 10.36106/ijar
LMA Supreme®, and Laryngeal Tube Suction-D found i-gel® with
95% insertion success rate and the highest airway compliance. Sharma
.15
et al compared respiratory mechanics of I gel and LMA proseal found
that PLMA formed better seal but dynamic compliance was higher
with the i-gel (p<0.05).
In our study, mean duration of ventilation and stay in ICU were almost
comparable among groups with no signicant statistical difference. It
showed that in our study there was no effect of type of airway on
overall status of the ICU patients.
In bot h g rou ps, co mplicati ons vi z. gastr ic insufat ion an d
dislodgement were found absent (100.0%) in all patients. In contrast,
in Group B, the laryngospasm was found present in 1 (5.0%) patient
but in Group A, it was absent (100.0%) in all patients and the difference
was also insignicant (p>0.05). Conversely, sore throat was present in
2 (10.5%) patients in Group A while 1 (5.0%) patient in Group B but
the difference did not reach statistical signicance i.e. found to be
16
statistically the same. Luce et al. compared SAD vs tracheal
intubation in children:a quantitative meta-analysis of respiratory
complications: During recovery from anesthesia, the incidence of
desaturation (OR= 0.34 [0.19–0.62]), laryngospasm (OR = 0.34
[0.2–0.6]), cough(OR = 0.18 [0.11–0.27]), and breath holding (0.19
[0.05–0.68]) was lower when laryngeal mask airway was used to
17
secure the airway. Jadhav PA et al. 2015 compared I-gel and LMA
proseal in anaesthetized spontaneously breathing patients there were
no signicant differences in demographic and hemodynamic data.
12
Sidiqui et al. reported that after removal of I-gel no blood staining on
device was noted and coughing was observed in 6% patients and sore
throat was noted in only one case after 24 hours of surgery. Hence, i-gel
can be a safe and suitable alternative to ETT.
So we can say that Patients in both the groups were ventilated properly
and there was no inuence of type of airway used on overall morbidity
of patient in intensive care settings.
CONCLUSION
For the short term mechanical ventilation i-gel can be used as safe
alternative to endotracheal intubation in selected patients. By avoiding
int ubation we can overco me t he complic ati on a ssociat ed t o
endotracheal intubation and as it require less amount of sedation so
early withdrawal can be possible and there are less chances of
ventilator associated pneumonia and other complication of prolong
mechanical ventilation.
Tables:
Table 1. Demographic Characteristics of Two Groups
Table 2. P/F ratio (Mean ± SE) of Two Groups over the Periods
Table 3. Ventilation Time and ICU Stay (Mean ± SE) of Two
Groups
Table 4. Distribution of Complications during Ventilation and
after Removal of Airway of Two Groups
Figure 1. Mean SBP of Two Groups over the Periods
Figure 2. Mean PAP of Two Groups over the Periods
Figure 3. Mean SC of Two Groups Over the Periods
INDIAN JOURNAL OF APPLIED RESEARCH
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Volume - 11 | Issue - 02 | February - 2021 | . PRINT ISSN No 2249 - 555X | DOI : 10.36106/ijar
Demographic
Characteristics
Group A (N=19)
Group B (N=20)
Age (Yrs), Mean ± Se
30.95 ± 1.97
29.65 ± 1.70
Sex ( Female: Male)
18 :1
19 :1
Weight (Kg) , Mean ± Se
53.37 ± 1.11
54.80 ± 0.78
Apache 2 (Score), Mean ± Se
18.00 ± 0.43
17.30 ± 0.44
Time period
Group A (n=19)
Group B (n=20)
p Value
Baseline
220.74 ± 2.90
221.25 ± 4.11
0.929
1 hr
231.42 ± 4.61
250.10 ± 5.08
0.004
3 hr
249.68 ± 4.8
260.90 ± 3.27
0.128
1 hr after
removal
262.26 ± 2.55
272.75 ± 2.98
0.070
12 hr after
removal
282.37 ± 4.92
291.75 ± 4.79
0.105
24 after removal
331.26 ± 3.57
346.30 ± 4.27
0.009
Variable
Group A
(n=19)
Group B
(n=20)
t-value
p-value
Ventilation time (hrs):
Mean ± SE
5.79 ± 0.22
5.90 ± 0.24
0.34
0.739
Range (min to max)
4 to 7
4 to 8
Median
6
6
ICU stay (days):
Mean ± SE
3.21 ± 0.21
3.45 ± 0.22
0.78
0.441
Range (min to max)
2 to 5
2 to 5
Median
3
4
Complications
Group A
(n=19) (%)
Group B
(n=20) (%)
p-value
Gastric insufation:
No
19 (100.0)
20 (100.0)
-
Dislogement:
No
19 (100.0)
20 (100.0)
-
Laryngospasm:
No
Yes
19 (100.0)
0 (0.0)
19 (95.0)
1 (5.0)
0.323
Sore throat:
No
Yes
17 (89.5)
2 (10.5)
19 (95.0)
1 (5.0)
0.517
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INDIAN JOURNAL OF APPLIED RESEARCH
Volume - 11 | Issue - 02 | February - 2021 | . PRINT ISSN No 2249 - 555X | DOI : 10.36106/ijar