Baska Vs - I.gel
Baska Vs - I.gel
Baska Vs - I.gel
101407
Department of Anaesthesiology and Intensive Care, School of Medical Sciences, Universiti Sains Malaysia, Kubang Kerian,
Kelantan, Malaysia
Hospital USM, Universiti Sains Malaysia, Kubang Kerian, Kelantan, Malaysia Country, Malaysia
The invention of supraglottic airway devices The i-gel (Intersurgical Ltd, Wokingham, UK) is
(SGADs) has initiated a new era of modern airway an evolutionary example of the second generation
management and it is considered to be an impor- of SGADs (Figures 1 and 2). It takes its name from
tant milestone towards improving patient safety the soft gel-like material from which it is made. Its
during anaesthesia. The LMA-Classic (inTRAvent shape, softness and contours accurately mirror the
Medical, Maidenhead, UK) was the first SGAD intro- perilaryngeal anatomy to create the perfect fit and
duced into clinical practice in 1983 by Archie Brain a reliable perilaryngeal seal without the need for an
and was regarded as a first-generation SGAD [1]. inflatable cuff. This key feature means the insertion
First-generation SGADs were just a simple airway of the i-gel is designed to be easy, rapid and consis-
tube that was initially designed for securing the air- tently reliable. There are a few other special features
way as an alternative to an endotracheal tube dur- of the i-gel that can provide additional benefits,
ing emergency situations. It subsequently showed including a gastric channel, an integral bite block,
benefits for patients undergoing general anaesthe- a buccal cavity stabiliser and an epiglottic rest.
sia [2]. Over the years, numerous enhancements The gastric channel has proximal and distal ends that
have resulted in the creation of improved second- can provide an early warning of regurgitation, allow-
generation SGADs that aimed to allow a higher ing for the passage of a nasogastric tube to empty
positive airway pressure while reducing the risk of the stomach contents and facilitate venting; the
pulmonary aspiration by adding a gastric access integral bite block reduces the possibility of airway
port for evacuation of the stomach contents [3]. channel occlusion; the buccal cavity stabiliser aids in
383
Thanesh Kumar Sinasamy, Wan Mohd Nazaruddin Wan Hassan, Rhendra Hardy Mohamad Zaini, Praveena Seevaunnamtum, Laila Ab Mukmin
FIGURE 1. Comparison of i-gel and Baska Mask supraglottic airway FIGURE 2. Comparison of i-gel and Baska Mask supraglottic airway
devices from anterior view; top: Baska Mask, bottom: i-gel devices from lateral view; top: Baska Mask, bottom: i-gel
insertion and eliminates the potential for rotation; of insertion, quality of ventilation and incidence of
and the epiglottic rest reduces the possibility of epi- post-insertion complications than the i-gel.
glottic ‘down folding’ and airway obstruction [4, 5].
The Baska mask (Logikal Health Products, Moris- METHODS
set, NSW, Australia) is another innovative SGAD (Fig- This was a single-blinded, randomised con-
ures 1 and 2). It is marketed as a third-generation trolled trial, comparing the Baska mask and i-gel
SGAD, but this claim is questioned and challenged in patients undergoing elective surgery. The study
by some authors [6]. It has an advanced self-sealing was conducted after obtaining approval from
variable pressure cuff that can produce an effective the Human Research Ethics Committee of the
seal with the larynx, which increases proportionately Universiti Sains Malaysia (approval code: USM/
with the increase of airway pressure during positive JEPeM/17050246) and written consent from patients.
pressure ventilation. The airway opening is also ad- The inclusion criteria were patients aged 18 to
vanced, which provides superior seal patency and 60 years, of American Society of Anesthesiologists
increased protection against gastric overflow. It also (ASA) class I and II, and who had a body mass index
has superior gastric reflux drainage with a large distal (BMI) of less than 35 kg m-2. Patients were excluded
aperture located at the upper oesophagus and open from the study if they were pregnant, undergoing
to the sump cavity for easy drainage of gastric fluid. laparoscopic or head and neck surgery, had a previ-
A suction attachment is available and suitable for ous history of difficult intubation or were at risk of
placement on either side of the drainage to keep the gastric aspiration. Patients who required unforeseen
sump area clear and minimise the risk of aspiration. tracheal intubation, muscle paralysis or unplanned
There is also a bite block to protect the airway tube intensive care unit admission post-operatively were
from being compressed by a patient’s bite. The Baska withdrawn from this study.
mask also has an additional part that further differen- Patient eligibility screening was conducted
tiates it from the i-gel called an insertion tab, which during pre-operative assessment at least a day be-
is used for manually curving the mask for easy inser- fore surgery. A total of 80 adult patients who were
tion. The Baska mask achieves a high seal pressure, scheduled for elective surgery were randomised to
effective ventilation and quick access to drain gastric two groups using computer-generated randomisa-
contents [7, 8]. tion software: Group BM: Baska mask (n = 40) and
The similarity of these two SGADs are the Group IG: i-gel (n = 40). The randomisation alloca-
non-inflatable cuff features, which are considered tions were subsequently concealed in a sealed en-
by some to be the main feature of the so-called velope. All selected patients were given a 3.75 to
third-generation SGADs in comparison to the ear- 7.5 mg premedication tablet of midazolam the
lier second-generation SGADs, such as the LMA- night before the surgery. Upon arrival at the opera-
Proseal, LMA-Fastrack, etc. There have been very tion theatre (OT) reception area, the envelope con-
limited studies comparing the igel and Baska mask. taining the randomisation allocation was opened
Therefore, the aim of this study is to compare the by the anaesthesia nurse to determine the type of
effectiveness of the i-gel and the Baska mask in SGAD that would be used for the respective patient.
terms of quality of insertion, quality of ventilation The selected SGAD was not revealed to the operator
and incidence of post-insertion complications. We until just before the insertion (Figure 3).
hypothesised that the Baska mask as a newer SGAD Upon arrival inside of the OT, standard anaes-
with non-inflatable cuff is better in terms of quality thetic monitoring was applied to all patients, which
384
Comparison of the Baska mask and the i-gel supraglottic airway devices in patients undergoing elective surgery
included non-invasive blood pressure monitoring, Enrolment Assessed for eligibility (n = 90)
an electrocardiogram, capnography and pulse oxi
metry. The preparation of the SGAD was done by Excluded (n = 10)
the anaesthesia nurse. The size of the Baska mask • Not meeting inclusion criteria (n = 8)
and that of the i-gel were chosen based on the pa- • Declined to participate (n = 2)
tients’ ideal body weight, as per the manufacturers’ • Other reasons (n = 0)
recommendations for each device. The size recom-
Randomized (n = 80)
mendation for the Baska mask was size 3 for patients
< 50 kg, size 4 for patients 50 to 70 kg and size 5 for
patients > 70 kg, whereas the size recommendation
Allocation
for the i-gel was size 3 for patients 30 to 60 kg (small
adult), size 4 for patients 50 to 90 kg (medium adult) Allocated to Group BM (n = 40) Allocated to Group IG (n = 40)
• R eceived allocated intervention • R eceived allocated intervention
and size 5 for patients > 90 kg (large adult). Prepara-
(n = 40) (n = 40)
tion of the Baska mask and the i-gel with appropriate
• D id not receive allocated • D id not receive allocated intervention
lubrication using lignocaine gel was done according intervention (n = 0) (n = 0)
to the manufacturers’ recommendations. The inser-
tion technique for each device was also done accord- Follow-up
ing to the manufacturers’ guidelines.
All device insertions were performed by the Lost to follow-up (n = 0) Lost to follow-up (n = 0)
anaesthesia medical officer in charge in the specific Discontinued intervention (n = 0) Discontinued intervention (n = 0)
OT. All anaesthesia medical officers were post-grad-
uate specialty trainees in anaesthesia who had had Analysis
more than 3 years of experience in anaesthesia prac-
Analysed (n = 40) Analysed (n = 40)
tice and already had previous experience inserting
• Excluded from analysis (n = 0) • Excluded from analysis (n = 0)
at least 20 SGADs. The specific SGAD was prepared
by the anaesthesia nurse and was handed to the FIGURE 3. Consort flow diagram
operator just prior to the insertion. The insertion was
performed with the patient’s head in the neutral po- airway device was removed from the mouth and
sition. Successful placement was confirmed by the bag-mask ventilation in between insertion attempts
presence of adequate bilateral chest expansion and was needed. If patients had transient post-induction
a satisfactory end-tidal carbon dioxide waveform. The apnoea, ventilation was supported until adequate
insertion time, which was defined as the time taken spontaneous ventilation returned. Anaesthesia was
from the moment the device was handed to the op- maintained with sevoflurane throughout surgery
erator until satisfactory ventilation was achieved, was without the use of any muscle relaxants.
recorded by the anaesthesia nurse using a digital Heart rate, systolic blood pressure (mm Hg), dia-
timer. After successful insertion, the ease of insertion stolic blood pressure (mm Hg), mean arterial pres-
was rated based on a 4-point verbal rating scale (VRS; sure (mm Hg), and oxygen saturation were recorded
Table 1). A maximum of three attempts was permit- at baseline before induction, and at 1 min, 3 min,
ted for each patient and each new attempt was con- 5 min, 10 min and 20 min after SGAD insertion.
sidered to be a re-insertion of the device. The oropharyngeal leak pressure (OLP) was mea-
If the SGAD did not function effectively, the ma- sured after successful insertion and satisfactory
nipulations could be performed either by increasing ventilation using the closed-circuit mechanical ven-
the depth of insertion, rotating the SGAD or with- tilator in the operating room. The airway pressure
drawing the SGAD slightly. Each manipulation was was gradually increased by keeping a flow rate of
recorded as a manoeuvre attempt, and if these ma- 4 L min -1 with a maximum pressure limit of
noeuvres were unsuccessful in achieving effective
ventilation, the device was removed. If the problem TABLE 1. Ease of insertion scale for SGAD insertion
was predominantly due to a large leak, a device that Scale Difficulty Denomination
was one size larger was inserted. If the initial size
0 Very easy Assistant help not required
was considered too large, a smaller device was in- No tactile resistance encountered
serted. A change in device size was recorded as an
1 Easy Jaw thrust by assistant or tactile resistance encountered
insertion attempt. If the SGAD insertion failed after
three attempts, tracheal intubation was performed. 2 Difficult When jaw thrust and deep rotation are required,
or second attempt was required for successful device insertion
Insertion failure was defined as either three unsuc-
cessful attempts or if the entire process of insertion 3 Fail Insertion not possible despite manoeuvres,
exceeded 120 s. This included the time when the resulting in intubation after 3 unsuccessful attempts
385
Thanesh Kumar Sinasamy, Wan Mohd Nazaruddin Wan Hassan, Rhendra Hardy Mohamad Zaini, Praveena Seevaunnamtum, Laila Ab Mukmin
40 cm H2O. The pressure at which audible noise was and 40 control subjects to be able to reject the null
detected by a stethoscope just lateral to the thyroid hypothesis with a power of study of 0.8. Therefore,
cartilage was recorded as the OLP. The peak airway the total sample size was 80.
pressure (PAP) in cm H2O was documented 5 min The statistical analysis was conducted using
after successful SGAD insertion. The volume of ex- SPSS software version 24.0 (IBM Corp., USA). The
pired and inspired tidal volume (V T ) was also docu- analysis for categorical data was conducted using the
mented at 5 min after successful insertion. c2 test or Fisher’s exact test. The analysis for numeri-
After surgery was completed, sevoflurane inha- cal data was conducted using the independent t-test
lation was stopped and the patient was prepared for or Mann-Whitney test. Power of study was 0.8 and
extubation. The airway device was removed when a P-value of .05 was considered statistically significant.
the patient was awake and fulfilled all the criteria
of recovery from anaesthesia. Complications, such RESULTS
as injury of the teeth, gums or tongue, were as- A total of 80 patients were recruited for this
sessed after the removal of the SGAD. The presence study, and patients were divided into two groups
of blood staining on the SGAD was documented. with 40 patients in each group based on SGAD type.
The patient was then monitored at the post-oper- There were no significant differences in demograph-
ative recovery bay and was interviewed to assess ic profile in terms of age, gender, weight, height,
whether complications of throat pain/soreness, BMI, Mallampati score, thyromental distance, mouth
nausea or vomiting were present. If a patient expe- opening measurement or duration of surgery be-
rienced post-operative nausea or vomiting (PONV), tween Group BM and Group IG (Table 2).
anti-emetics were administered. The degree of In terms of ease of insertion, there was a signifi-
throat soreness was assessed using a 4-point VRS cant difference between the two groups (P < 0.001).
before discharge from the OT recovery bay. A rat- Group IG showed a higher percentage in the ‘very
ing of 0 was considered no pain, 1 as mild pain, 2 as easy’ insertion category than Group BM (62.5% and
moderate pain and 3 as severe pain. 10.0%, respectively). There was also no failure of in-
The sample size was calculated using Power sertion in Group IG when compared to Group BM
and Sample Size Calculations software, version (0.0% and 5.0%, respectively). However, the major-
3.0 (January 2009, 1997–2009 by William D. Dupont ity of Group BM (77.5%) were still within the ‘easy’
and Walton D. Plummer). Based on the study by insertion category, which was still considered to be
Ekinci et al. on number of insertion attempts, the a good outcome (Table 2). Group IG also showed sig-
failure rate among controls was 0.9999. If the true nificantly shorter median insertion time than Group
failure rate for experimental subjects was 0.825 [9] BM (13.3 s [interquartile range, IQR 7.8] and 17.0 s
we were required to study 40 experimental subjects [IQR 9.6], respectively; P < 0.001; Table 2). In terms
of number of insertion attempts, there were no sig-
nificant differences between the groups (P = 0.055).
TABLE 2. Demographic profile
However, based on percentage, Group IG showed
Variable Group BM Group IG P a slightly higher percentage in the successful single
(n = 40) (n = 40) attempt category than Group BM (92.5% and 77.5%,
Age (years), mean ± SD 33.8 ± 11.6 30.2 ± 11.1 0.166 respectively; Table 2). In terms of number of correc-
Body mass (kg), mean ± SD 66.3 ± 8.3 66.6 ± 9.9 0.893 tive manoeuvres after insertion, there was a signifi-
Height (cm), mean ± SD 168.5 ± 6.5 168.7 ± 7.7 0.925 cant difference between the two groups (P = 0.003),
BMI (m kg–2), mean ± SD 22.7 ± 2.7 23.3 ± 2.6 0.387 with Group IG showing a higher percentage in the
no manoeuvre at all category compared to Group
Thyro-mental distance (cm), 4.8 ± 0.6 4.9 ± 0.6 0.511
mean ± SD BM (92.5% and 72.5%, respectively; Table 2).
In terms of ventilation quality, Group IG showed
Mouth opening (cm), mean ± SD 3.9 ± 0.6 4.0 ± 0.6 0.378
a significantly lower value in generated PAP than
Duration of anaesthesia (min), 102.1 ± 42.5 104.1 ± 41.0 0.833
Group BM (11.5 cm H2O [2.2] and 12.7 [1.8] cm H2O,
mean ± SD
respectively; P = 0.010; Table 3). However, the mean
Mallampati, n (%) > 0.95 PAP for Group BM was still considered within a good
1 32.0 (50.8) 31.0 (49.2) range. There were no significant differences in other
2 8.0 (50.0) 8.0 (50.0) ventilation parameters, such as inspired and expired
3 0.0 (0.0) 1.0 (100.0) V T or OLP (Table 3).
Gender, n (%) 0.651 In terms of complications, there was a significant
difference in terms of throat soreness between the
Female 16.0 (47.1) 18.0 (52.9)
two groups (P = 0.042). Group IG showed a higher
Male 24.0 (52.2) 22.0 (47.8) percentage of no throat pain than Group BM (67.5%
386
Comparison of the Baska mask and the i-gel supraglottic airway devices in patients undergoing elective surgery
and 42.5%, respectively). There were no significant TABLE 3. Quality of supraglottic airway device insertion
differences in other complications, such as blood Parameter Group BM Group IG P
staining on the device, PONV and airway trauma. (n = 40) (n = 40)
Ease of insertion scale, n (%) < 0.001
DISCUSSION
Very easy 4.0 (10.0) 25.0 (62.5)
Our study was conducted to compare the two
Easy 31.0 (77.5) 14.0 (35.0)
latest types of second-generation SGADs: the Baska
mask and i-gel. Our results showed that the i-gel Difficult 3.0 (7.5) 1.0 (2.5)
resulted in a significantly shorter median insertion Fail 2.0 (5.0) 0.0 (0.0)
time, a higher percentage in the ‘very easy’ ease of Insertion time (s), median (IQR) 17.0 (IQR 9.6) 13.3 (IQR 7.8) < 0.001
insertion category, a higher percentage in the no Number of insertion attempts, n (%) 0.055
requirement of corrective manoeuvre category and 1 31.0 (77.5) 37.0 (92.5)
a higher percentage in the no post-operative throat 2 7.0 (17.5) 1.0 (2.5)
pain category than the Baska mask. However, the
3 1.0 (2.5) 2.0 (5.0)
Baska mask showed superiority in the category of
>3 1.0 (2.5) 0.0 (0.0)
higher generated PAP, which might indicate a better
cuff seal. Otherwise, there were no significant differ- Number of corrective manoeuvres after insertion, n (%) 0.003
ences in number of attempts, inspired or expired VT, 0 29.0 (72.5) 37.0 (92.5)
OLP and complications such as blood staining on 1 11.0 (27.5) 1.0 (2.5)
the device, PONV and airway trauma. 2 0.0 (0.0) 1.0 (2.5)
There have been some recent studies compar- ≥3 0.0 (0.0) 1.0 (2.5)
ing the Baska mask and i-gel and the conclusions
have been mixed. A few studies have shown that
TABLE 4. Ventilation parameters and oropharyngeal leak pressure
the parameters of the i-gel are superior to the Bas-
ka mask, which is supported by our study. Bindal Variable Group BM Group IG P
et al. conducted a comparison study between three (n = 40) (n = 40)
types of SGADs – the Baska mask, i-gel and LMA- Inspired tidal volume (VT) (mL), 436.7 ± 43.2 441.1 ± 47.7 0.673
Classic – in 150 patients undergoing outpatient mean ± SD
urologic interventions. Out of the few parameters Expired VT (mL), mean ± SD 420.4 ± 41.9 424.9 ± 47.6 0.663
assessed, only insertion and ventilation times were Peak airway pressure (cm H2O), 12.7 ± 1.8 11.5± 2.2 0.010
significantly different between the three groups. mean ± SD
The Baska mask showed the longest insertion and Oropharyngeal leak pressure (cm H2O), 23.7 ± 3.4 24.5 ± 2.5 0.242
ventilation times among the groups, with 12.04 s mean ± SD
± 6.25 s and 21.26 s ± 8.53 s, respectively. The short-
est time was shown by the LMA-Classic group,
which was 5.78 s ± 1.72 s for insertion time and TABLE 5. Complications of supraglottic airway device insertion
11.72 s ± 4.72 s for ventilation time. The first-attempt Variable Group BM Group IG P
success rates were also highest for the LMA-Classic (n = 40) (n = 40)
at 98%, followed by 92% for the i-gel and 88% for Blood stained, n (%) > 0.95
the Baska mask. Besides that, 20% of the Baska mask No 39.0 (97.5) 39.0 (97.5)
group required additional manoeuvres, which was Yes 1.0 (2.5) 1.0 (2.5)
more than the other groups. This study concluded
Post-operative nausea or vomiting, n (%) > 0.95
that the LMA-Classic and igel showed superior re-
sults in insertion and ventilation times, first-attempt No 38.0 (95.0) 37.0 (92.5)
success rates and no additional manoeuvres than Yes 2.0 (5.0) 3.0 (7.5)
the Baska mask [10]. Kara et al. conducted a com- Airway injury, n (%) Not applicable
parison study between the Baska mask and i-gel in
200 patients undergoing urologic surgery. The i-gel No 40.0 (100.0) 40.0 (100.0)
showed significantly shorter median insertion time Yes 0.0 (0.0) 0.0 (0.0)
than the Baska mask (7 s [5–12] and 14 s [6–25], Throat pain score, n (%) 0.042
respectively). However, there were no significant
No pain 17.0 (42.5) 27.0 (67.5)
differences in the other parameters (the number of
Mild pain 22.0 (55.0) 13.0 (32.5)
device placement attempts, sealed pressure and the
number of post-operative complications) [11]. Moderate pain 1.0 (2.5) 0.0 (0.0)
A few studies have highlighted the superiority
of certain parameters of the Baska mask over the
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Thanesh Kumar Sinasamy, Wan Mohd Nazaruddin Wan Hassan, Rhendra Hardy Mohamad Zaini, Praveena Seevaunnamtum, Laila Ab Mukmin
388