Comparison of Different Cuff Pressure Use with the Supreme Laryngeal Mask Airway on Haemodynamic Response, Seal Pressure and Postoperative Adverse Events: A Prospective Randomized Study/Farkli Kaf Basinci ile Kullanilan Supreme Laringeal Maskenin Hemodinamik Cevap, Kacak Basinci ve Postoperatif Yan Etkiler Acisindan Karsilastirilmasi: Prospektif Randomize Bir Calisma.
Supraglottic airway (SGA) devices and the models developed for their use have been an alternative to endotracheal tubes for many years in anaesthesia practice (1, 2). The Supreme[TM] laryngeal mask airway (SLMA) is a relatively new type of SGA device (3, 4). Several studies have indicated that SGA devices, including the SLMA, cause lower haemodynamic responses during intubation and reduce post-operative side effects compared to endotracheal tubes (5, 6). Increases in blood pressure can be dangerous after intubation, particularly in hypertensive patients, and maintaining normal blood pressure provides safer induction of anaesthesia in this patient group. The SLMA and other SGA devices also lead to an increase in blood pressure depending on the level of pharyngeal stimulation. Also, there is speculation that high SLMA intracuff pressures reduce mucosal perfusion leading to postoperative complications (7). Many studies indicate that reduction and monitorisation of the intracuff pressure of SGA devices lowers the incidence of postoperative pharyngolaryngeal complications (8, 9). In the literature, there are no studies about the effects of reducing the intracuff pressure of SGA devices on haemodynamic response in hypertensive patients. In addition, the use of SLMAs with lower intracuff pressure than recommended has not been investigated. We hypothesized that the patients' haemodynamic responses to intubation and postoperative side effects can be decreased by using the SLMA with intracuff pressures lower than the manufacturer's recommendation without any negative effect on airway safety.
In the present study, we aimed to compare the use of SLMAs with normal cuff pressure (60 cm [H.sub.2]O) and low cuff pressure (45 cm [H.sub.2]O) with haemodynamic response as the primary goal and insertion features (the success of insertion and the time for insertion), seal pressure, fibreoptic score and postoperative side effects as secondary goals.
Ethics approval for this study (Ethics Committee No. 2013/1228) was provided by Istanbul University Istanbul School of Medicine on 06 September 2013. Written informed consent was obtained from the patients.
Using randomization, 120 patients were equally divided into two groups: a low pressure group (Group L) and normal pressure group (Group N) with an equal number of cases. Data collection and ensuring that the cuff was inflated to the appropriate pressure and maintained throughout the operation was done by two different anaesthetists.
This study included patients who were diagnosed with hypertension and who were administered antihypertensive drugs. The weight range of the patients was 50-100 kg, and they were all status II according to the American Society of Anesthesiologists (ASA). All patients were scheduled for varicose vein or inguinal hernia surgeries at Istanbul Medical Faculty. Patients were excluded if they had pre-existing pharyngolaryngeal symptoms, a recent history of an upper respiratory tract infection, contraindications to the use of a laryngeal mask airway device (e.g. body mass index >40 kg/[m.sup.2]), a symptomatic hiatal hernia, or severe gastroesophageal reflux disease.
Clinical observations and procedure
A #4 SLMA (The Laryngeal Mask Company Limited, St. Helier, Jersey, Channel Islands) was used for patients weighing <70 kg, and a #5 SLMA was used for patients weighing 70-100 kg to ensure airway patency in all patients. The SLMA was prepared by placing the cuff in such a way that it was completely reduced in all patients, as done in the study by Timmermann et al. (10). The SLMA was inserted using the one-handed rotational technique, with the patient's head in the neutral position (10, 11). The insertion of SLMAs was done by the same anaesthesia resident (with experience of applying more than 200 SLMAs). Demographic parameters (age, height and weight), Mallampati score and the type and duration of surgery were recorded. Patients were monitorised for heart rate (HR) by three-channel electrocardiography, non-invasive blood pressure, peripheral oxygen saturation (Sp[O.sub.2]), entidal C[O.sub.2] (etC[O.sub.2]) (Datex-Ohrneda S/5TM Compact Critical Care Monitor), bispectral index (BIS; A-2000 BIS monitoring system, Aspect Medical Systems, BIS XP, Framingham, MA, USA), and neuromuscular transmission (TOF-T1; TOF-Watch SX[R] Organon Instruments, Boxlet, Netherlands). For anaesthesia induction, 1 mcg [kg.sup.-1] fentanyl and 0.6 mg [kg.sup.-1] rocuronium bromide were administered, and 1% propofol was used until the BIS value was below 60. In order to standardise the patients' condition during SLMA insertion, the insertion was conducted when BIS was between 50 and 60 and T1 was 0. After placing the SLMA, the cuff was inflated until its pressure reached 45 cm [H.sub.2]O in Group L and 60 cm [H.sub.2]O in Group N as measured by a cuff pressure manometer (Portex cuff inflator pressure gauge, Smiths Medical International Limited, UK). During the surgery, cuff pressure was monitored, and the target cuff pressure was maintained in all patients. Two attempts were allowed for SLMA insertion in both groups. The SLMA was deemed to be accurately placed in this study, as it was in the previous studies, by the absence of a leaking sound, and it was properly verified by obtaining a capnography curve (10). When the placement was not effective, the position was optimized by gently pushing the SLMA further down the pharynx and/or to the lateral side using the fixation tab until the air leak ceased. In case of failure in Group L, a second attempt was allowed, and after the second attempt the SLMA cuff was inflated up to 60 cm[H.sub.2]O. However, the patient was intubated if correct placement of the SLMA was still not achieved. In Group N, patients were intubated if a second attempt was unsuccessful. The success rate and duration of SLMA insertion, the number of attempts and the insertion complications were recorded for each group. The time to achieve a successful insertion was defined as the time from removing the face mask from the patient to the first valid capnography reading. After proper placement, a size 14-French gastric tube was inserted through the drain tube. The success rate and duration of insertion were recorded. Following these procedures, fresh gas flow was adjusted to 6 L [min.sup.-1] (a 1:1 mixture of [O.sub.2] and air) during the surgery. Sevoflurane was used as an inhalation agent for anaesthesia maintenance. Tidal volume was adjusted to 8 mL [kg.sup.-1] with 12/min respiratory rate by volume-controlled ventilation mechanics (Datex-Ohmeda S/5 Avance).
HR, mean arterial pressure (MAP) and peripheral oxygen saturations of the patients were recorded before (after induction) and after insertion of the SLMA (immediately and after 2 min), during the surgery (15th min, 30th min and 45th min), and before and after extubation. During the surgery, the percentage of tidal volume leakage, Ppeak, Pmean, etC[O.sub.2], seal pressure and fibreoptic scores of all patients were measured three times, and the mean values were recorded. In order to calculate the percentage of leakage, the expiratory tidal volume was extracted from the inspiratory tidal volume, and the result was proportioned to the inspiratory tidal volume. The seal pressure was determined using a technique similar to the one followed by Keller and Shimbori (12, 13) by closing the expiratory valve of the circle system at a fixed gas flow of 3 L [min.sup.-1] (maximum allowed was 40 cm [H.sub.2]O) and noting the airway pressure at which equilibrium was reached. At this time, gas leakage was determined at the mouth (audible) and the stomach (epigastric auscultation).
Fibreoptic scores were recorded on a scale of 1 to 4 (4=only vocal cords visible, 3=vocal cords plus posterior epiglottis visible, 2=vocal cords plus anterior epiglottis visible, 1=vocal cords not seen), where a score of 1 was considered the worst and a score of 4 was considered the best (14). During the surgery, patients with an audible air leak and fibreoptic score of 1 were evaluated for SLMA shift, and the number of SLMA shifts in both groups was also recorded. After surgery, all patients were taken to the recovery unit and observed for at least 1 hour. When modified Aldrete scores were 10, the patients were transferred to the ward. Observed adverse effects, such as blood staining of the device, sore throat, hoarseness, aphasia, nausea, vomiting and agitation were recorded in the recovery room period.
Sample size was calculated according to the pilot study (including 10 patients per group) and was based on MAP measurement immediately after SLMA insertion. In the pilot study, we found MAP values of 86.3[+ or -]10.5 mmHg and 93.2[+ or -]11.3 mmHg for Group L and Group N, respectively. The minimum number of patients needed for both groups was calculated to be AA patients for a type 1 error of 0.05 and a power of 0.9. Results are expressed as means[+ or -]standard deviation (SD). All statistical analyses were conducted using Statistical Package for the Social Sciences for Windows version 15.0 (SPSS Inc.; Chicago, IL, USA). Students t-test and the Mann-Whitney U test were used for comparison of quantitative variables. Qualitative variables were compared using chi-square tests. A p value <0.05 was considered statistically significant.
A total of 120 patients were included at the beginning of the study, but 21 patients were subsequently excluded for various reasons (Figure 1). Forty-nine patients in Group L and 50 patients in Group N completed the study. In terms of demographic data and Mallampati scores, there was no significant difference between the groups (Table 1). The mean durations of surgeries were 58.0[+ or -]12.2 min and 56.1[+ or -]10.2 min for Group L and Group N, respectively (p=0.932). Fifteen patients used ACE inhibitors, six patients used diuretics, twelve patients used beta blockers, seven patients used alpha blockers and nine patients used calcium channel blockers preoperatively in Group L. Twelve patients used ACE inhibitors, seven patients used diuretics, fourteen patients used beta blockers, seven patients used alpha blockers and ten patients used calcium channel blockers preoperatively in Group N.
Parameters of laryngeal mask and gastric tube insertion
In Group L, the SLMA was successfully inserted in 44 patients (89.7%) on the first attempt and in all remaining patients on the second attempt. In Group N, the SLMA was successfully inserted in 46 patients (92%) on the first attempt and in all remaining patients on the second attempt. The success rate and duration of insertion were similar in both groups (Table 2). Fibreoptic average score was similar between both groups (Table 2). In both groups, the SLMA was not displaced in any patient during the surgery. The success of gastric tube placement and duration were similar between the groups (Table 2).
Figure 2. Mean arterial pressure and heart rate Group L Group N Baseline 79.3 81.2 Immediately 86.4 97.0 2nd min 85.4 94.9 (*) 15th min 80.6 82.8 30th min 77.1 80.0 45th min 76.4 78.9 Baseline 68.3 70.3 Immediately 78.3 91.0 (*) 2nd min 77.3 87.4 (*) 15th min 75.4 77.7 30th min 74.4 72.5 45th min 73.0 70.8 (*)p<0.001 Note: Table made from bar graph.
Parameters of ventilation
There was no difference between the two groups with respect to Ppeak, Pmean, etC[O.sub.2], or tidal volume leakage percentage values measured by a ventilator. The seal pressure was significantly higher in Group N than in Group L (Table 3).
Before the SLMA was placed, MAP and HR values were similar between the groups. However, immediately and 2 min after SLMA placement, MAP and HR values measured in Group L were significantly lower than those in Group N (Figure 2). However, during the rest of the surgery time the MAP and HR were similar between the two groups (Figure 2).
None of the patients in either group had dysphagia or dysphonia. The most common complications encountered in both groups were agitation, nausea/vomiting, sore throat and bleeding (Table 4). Blood staining and sore throat were observed less frequently in Group L (p<0.05).
In this study, we primarily noted that SLMA use with a low cuff pressure leads to lower haemodynamic response and fewer post-operative side effects compared with a normal cuff pressure. In addition, we determined that the use of a low cuff pressure did not negatively influence insertion success or ventilation parameters.
The SLMA led to a lower haemodynamic response compared with endotracheal intubation to ensure airway patency, which is similar to the findings of other SGA devices (6, 15). Blood pressure and HR increases during airway management because of stimulation of the vocal cords and/or pharynx (16). In our study, we aimed to reduce this undesirable effect by reducing stimulation of the pharynx by using a low cuff pressure. The present study is the first to examine this issue. We maintained the SLMA cuff pressure lower than that recommended in hypertensive patients, whose haemodynamic changes are more unstable than the normal patient population. These severe haemodynamic changes could cause dangerous complications such as acute coronary syndrome in hypertensive patients. With this procedure, we have successfully reduced the stress response to intubation. We noted that MAP and HR values after placement of the SLMA were significantly lower in Group L than in Group N. Haemodynamic response that occurs during intubation is influenced by the depth of anaesthesia (17, 18). In the present study, those effects were standardized by using BIS and TOF monitoring to provide similar conditions during SLMA placement in all patients. The literature contains many studies about the effects of endotracheal intubation compared to SGA devices on haemodynamic responses; however, there are no studies comparing the effect of different LMA cuff pressures on haemodynamic response. Several studies showed the relation between the LMA cuff pressure and post-operative side effects (19). Seet et al. (20), in their study of more than 200 ambulatory surgical patients, used manometry and limit intracuff LMA pressure less than 44 mmHg to decrease pharyngolaryngeal complications by 70% compared with routine care with high cuff pressure. Also, Wong et al. (21) noted that LMA did not cause any episodes of sore throat when cuff pressures of <40 cm [H.sub.2]O were used for 120 paediatric patients. In the present study, we found similar results showing that the incidences of blood staining and sore throat were <5% in Group L patients. These side effects were observed with incidences >15% in Group N. These results were significantly different between the groups. However, we cannot recommend the use of the SLMA with low-pressure cuff only on the basis of these positive effects. In addition, we need to ensure successful placement, provide airway security and ensure adequate seal pressure. Ferson et al. (22) showed SLMA placement success rates of 98% in their study. In the present study, we also noted a placement success rate of 100% in both groups. Moreover, we noted that the success rate and duration of insertion was similar between the two groups. Zhang et al. (23) used SLMAs with different cuff pressures in 123 cases and noted that a cuff pressure of 40 cm [H.sub.2]O did not affect the placement success and duration of insertion. In addition, monitoring for BIS and TOF allowed us to obtain similar conditions during insertion of the SLMA in our study (24). In this way, we were able to avoid misleading effects because of the difference in depth of anaesthesia and muscle relaxation.
The fibreoptic score provides more objective information compared with a capnography curve and other data about the accuracy of SLMA placement. In the present study, we used fibreoptic viewing to determine the accuracy of SLMA placement. A low cuff pressure did not cause any negative effect on fibreoptic score. This showed that SLMA positions were similar between the groups.
The seal pressure has also been used to indicate the feasibility of positive-pressure ventilation and the degree of airway protection (12). In previous studies, the SLMA seal pressure has ranged between 20 and 28 cm [H.sub.2]O when used with a normal cuff pressure (20, 25, 26). Compared with classic LMA, SLMA has a higher seal pressure. Furthermore, the SLMA has a wider range of use based on this feature. In particular, the SLMA can be used as safely as the ProSeal SLMA during laparoscopic procedures. Lee et al.(27) used the SLMA safely on 70 patients undergoing laparoscopic gynaecological surgery. In our study, neither group experienced any problem because of the seal pressure. Seal pressures of >20 cm [H.sub.2]O are usually adequate in ensuring airway security. However, high seal pressures are required in laparoscopic surgical procedures. Studies have found that the lower cuff pressure can cause reduced seal pressure, but this does not create a clinically significant problem. In the present study, clinically significant seal pressure differences were detected between the groups. We noted an approximate decrease of 2 cm [H.sub.2]O in seal pressure in Group L. Despite the decrease in seal pressure measuring 24 cm [H.sub.2]O, this result ensures a safe surgical procedure. Zhang et al. (23) investigated the effects of different SLMA cuff pressures on the seal pressures and detected a lower seal pressure in the group with a cuff pressure of 45 cm [H.sub.2]O.
Supreme[TM] laryngeal mask airway use with a cuff pressure of 45 cm [H.sub.2]O significantly decreases haemodynamic response and post-operative side effects compared with a cuff pressure of 60 cm [H.sub.2]O. According to our results, a lower cuff pressure has no negative effects on placement success or airway security. An average decrease of 2 cm [H.sub.2]O in seal pressure was noted only with the use of a lower cuff pressure. Therefore, except for some specific surgeries that require higher seal pressures, such as laparoscopic interventions, we recommend the use of the SLMA with cuff pressures <60 cm [H.sub.2]O.
Ethics Committee Approval: Ethics committee approval was received for this study from the ethics committee of Istanbul University Istanbul School of Medicine (No: 2013/1228).
Informed Consent: Written informed consent was obtained from patients who participated in this study.
Peer-review: Externally peer-reviewed.
Author Contributions: Concept - A.A; Design - A.A., N.T.; Supervision - I.O.A.; Resources - DA., N.S.; Materials - A.A.; Data Collection and/or Processing - A.A., M.Y.; Analysis and/or Interpretation - A.A., I.O.A., DA.; Literature Search - M.Y., A.A., N.T.; Writing Manuscript - A.A., I.O.A.; Critical Review - I.O.A., N.T., A.A.; Other-N.S.
Conflict of Interest: No conflict of interest was declared by the authors.
Financial Disclosure: The authors declared that this study has received no financial support.
Etik Komite Onayi: Bu calisma icin etik komite onayi Istanbul Universitesi Istanbul Tip Fakultesi'nden (No: 2013/1228) alinmistir.
Hasta Onami: Yazili hasta onami bu calismaya katilan hastalardan alinmistir.
Hakem Degerlendirmesi: Dis bagimsiz.
Yazar Katkilari: Fikir - A.A; Tasarim - A.A., N.T.; Denetleme - I.O.A.; Kaynaklar - D.A., N.S.; Malzemeler - A.A.; Veri Toplanmasi ve/veya Islemesi - A.A., M.Y.; Analiz ve/veya Yorum - A.A., I.O.A., D.A.; Literatur Taramasi - M.Y., A.A., N.T.; Yaziyi Yazan - A.A., I.O.A.; Elestirel Inceleme - I.O.A., N.T., A.A.; Diger - N.S.
Cikar Catismasi: Yazarlar cikar catismasi bildirmemislerdir.
Finansal Destek: Yazarlar bu calisma icin finansal destek almadiklarini beyan etmislerdir.
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Achmet Ali (1), Demet Altun (1), Nukhet Sivrikoz (1), Mesut Yornuk (1), Namigar Turgut (2), Ibrahim Ozkan Akinci (1)
(1) Department of Anaesthesiology, Istanbul University Istanbul School of Medicine, Istanbul Turkey
(2) Department of Anaesthesiology, Okmeydani Training and Research Hospital Istanbul Turkey
Cite this article as: Ali A, Altun D, Sivrikoz N, Yornuk M, Turgut N, Akinci IO. Comparison of Different Cuff Pressure Use with the Supreme Laryngeal Mask Airway on Haemodynamic Response, Seal Pressure and Postoperative Adverse Events: A Prospective Randomized Study. Turk J Anaesthesiol Reanim 2018; 46: 151-7.
Corresponding Author/Sorumlu Yazar: Achmet Ali
Received / Gelis Tarihi: 25.03.2017
Accepted / Kabul Tarihi: 14.07.2017
Available Online Date /
Cevrimici Yayin Tarihi : 27.11.2017
Table 1. Patient demographic parameters, operation time and Mallampati score Group L Group N (n=49) (n=50) Gender (M/F) 22/27 24/26 Age (years) 46.4[+ or -]13.2 44.5[+ or -]12.5 Height (cm) 163.2[+ or -]7.3 163.3[+ or -]7.1 Weight (kg) 71.8[+ or -]12.8 73.6[+ or -]13.5 Mallanpati score (I/II/III) 14/29/6 15/30/5 Type of operation (VV/IH) 30/20 33/17 Size of SLMA (number 4/number 5) 25/24 28/22 P Gender (M/F) 0.757 Age (years) 0.465 Height (cm) 0.956 Weight (kg) 0.502 Mallanpati score (I/II/III) 0.936 Type of operation (VV/IH) 0.534 Size of SLMA (number 4/number 5) 0.619 Data are mean[+ or -]SD or number of patients. M: male; F: female; VV: varicose vein; IH: inguinal hernia Table 2. Insertion success and fibreoptic score Group L Group N (n=49) (n-50) SLMA insertion success 44 (89.7%) 46 (92%) at first attempt SLMA insertion time (s) 12.3[+ or -]3.4 11.6[+ or -]3.1 Fibreoptic score 3.2[+ or -]0.8 3.4[+ or -]0.7 Gastric tube insertion success 45 (91.8%) 49 (98%) Gastric tube insertion time (s) 12.4[+ or -]3.5 11.6[+ or -]2.9 P SLMA insertion success 0.703 at first attempt SLMA insertion time (s) 0.242 Fibreoptic score 0.119 Gastric tube insertion success 0.161 Gastric tube insertion time (s) 0.245 Data are mean[+ or -]SD or number of patients. M: male; F: female; VV: varicose vein; IH: inguinal hernia Table 3. Ventilation parameters Group L Group N (n=49) (n-50) Airway sealing pressure 24.1[+ or -]3.1 26.2[+ or -]3.9 (cm [H.sub.2]O) Leakage percentage (%) 4.7[+ or -]1.6 4.4[+ or -]1.3 [P.sub.peak] (cm [H.sub.2]O]) 16.4 [+ or -] 2.0 17.1[+ or -]2.5 [P.sub.mean] (cm [H.sub.2]O) 6.7[+ or -]1.5 7.3[+ or -]1.8 etC[O.sub.2] (mmHg) 34.2[+ or -]2.6 33.6[+ or -]3.1 P Airway sealing pressure 0.003 (*) (cm [H.sub.2]O) Leakage percentage (%) 0.412 [P.sub.peak] (cm [H.sub.2]O]) 0.244 [P.sub.mean] (cm [H.sub.2]O) 0.173 etC[O.sub.2] (mmHg) 0.320 (*)p<0.05. Data are mean[+ or -]SD, etC[O.sub.2]: end-tidal C[O.sub.2] Table 4. Adverse effects Group L Group N (n=49) (n=50) P Blood staining 3 (6.1%) 10 (20%) 0.041 (*) Sore throat 1 (2%) 8 (16%) 0.046 (*) Agitation 7 (14.3%) 9 (18%) 0.616 Nausea and vomiting 6 (12.2%) 10 (20%) 0.295 (*)p<0.05. Data are numbers of patients and percentage.
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|Title Annotation:||Original Article / Ozgun Arastirma|
|Author:||Ali, Achmet; Altun, Demet; Sivrikoz, Nukhet; Yornuk, Mesut; Turgut, Namigar; Akinci, Ibrahim Ozkan|
|Publication:||Turkish Journal of Anaesthesiology and Reanimation|
|Date:||Apr 1, 2018|
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