Comparision of airway protector in laparoscopic surgery

Not yet recruiting

• Conditions: Calculus of gallbladder and bile duct with cholecystitis, (2) ICD-10 Condition: K87||Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere,

• Registration Number: CTRI/2022/06/043562
• Lead Sponsor: Department of Anaesthesiology

Brief Summary

**“COMPARISION OF LARYNGEAL MASK AIRWAY PROSEAL AND LARYNGEAL MASK AIRWAY PROTECTOR IN LAPAROSCOPIC SURGERY â€**

**INTRODUCTION**

Securing the airway is one of the primary concern of anaesthesiologist in patient undergoing surgery in general anaesthesia. Tracheal intubation has been for years the technique of choice for airway management during surgical procedures under general anesthesia. However, it is not a procedure without risk and limitation. Besides  technical challenge in tube placement there are some complication that range from events such as trauma in airway,laryngospasm laryngeal edema, to other minor events, such as hoarseness of voice and sore throat.1-3

This has led to  invention of new device called supraglottic airway device(SAD), especially used for minor or day care procedure. Classic laryngeal mask airway(LMA) is introductory type of device of SAD family and has been used for many years. Supraglottic devices have a number of advantages over endotracheal tube (ETT), as they do not require the use laryngoscope for insertion, minimal skill, less invasive and result in less hemodynamic response and airway manipulation.4

LMA is not found to fully protect the airway and problem encountered was low oropharyngeal leak pressure, gastric insufflation and consequently regurgitation and aspiration. Later modification was done to improve its sealing property by adding  a gastric channel in device and second generation and double lumen LMA has been introduced. In this second generation LMA include I gel, proseal LMA, supreme LMA, Baska mask, combitube etc.5

LMA Proseal is a double-lumen, double-cuff LMA. The double-tube design separated the respiratory and the alimentary tracks providing a separate passage for the regurgitated fluids. Furthermore, the double cuff provided a better seal around the glottis, thus providing an option of administering intermittent positive-pressure ventilation.6 These properties increase the suitability to use LMA Proseals in patients who are more prone to aspiration of regurgitated fluids.

Recently an new device LMA protector added in this family few years back a second generation perilaryngeal sealer type supraglottic airway device which  have two gastric channel for gastric drain found to have acceptable  placement on the first attempt,adequate oropharyngeal leak pressure and ventilation adequacy.7

Many studies have been done earlier  to compare their characterstic feature like oropharyngeal leak pressure, insertion success, airway morbidity of these device for use in clinical practice. There is no study done to compare between LMA proseal and LMA protector for their safety and efficacy so we designed study to compare oropharyngeal leak pressure and other property of LMA Proseal and LMA protector in laparoscopic surgery like laparoscopic cholecystectomy, appendicectomy,diagnostic laparoscopy, laparoscopic ovarian cystectomy etc. under general anesthesia.

 **AIM AND OBJECTIVE**

**Aim:**

·        To compare  LMA proseal and LMA protector in patients undergoing general anaesthesia for  laparoscopic surgery

**Primary Objectives:**

•      To compare oropharyngeal leak pressure (OLP) between LMA proseal and LMA protector in patients undergoing laparoscopic surgeries.

•      **Secondary Objective:** TO compare following parameters and event between LMA Proseal and LMA Protector

o   Time taken for successful placement of LMA

o   Total number of attempts in successful insertion of LMA

o   Hemodynamic changes  during  placement of LMA

o   Post operative  airway morbidity (hoarsness of voice, sore throat,dysphagia and trauma)

  ·

**MATERIAL AND METHODS**

**Study settings:**

The study will be conducted in Department of Anaesthesiology  in collaboration of various surgical department of   King George’s Medical University, Lucknow after taking written and informed  consent from the patients.

**Study duration:**

One year

**Study design:**

Prospective Randomized  comparative study

**Sample Size:**120 cases included in the study

On the basis of previous study, difference in the mean Oropharyngeal leak pressure after the release of carboperitoneum in between LMA Proseal group and LMA Supreme group (μ1��’μ2) was2.9[LMA ProSeal group =29.8and LMA Supreme group =26.9] and the average population variance (σ) was 5.3 (Anand et al., 2016). The sample size (n) = 2 (Zα/2 + Z [1-β])2 × σ2/( μ1��’μ2)2,assuming 0.05 level significance (Zα/2 =1.96), and 80% power (Z [1-β])=0.84) was 52 patients in each group of the study.

2 (Zα/2 + Z [1-β])2 × σ2

n=

(μ1��’μ2)2

 2 (1.96 + 0.84)2 × (5.3)2

n=

(29.8-26.9)2

n=52 To account for data loss/patient attrition and other exclusions ,60 patient will be included in each group .Total 120 patients will be recruited for the study.

**Inclusion Criteria:**

–     Patients of either sex aged 18-60 years of ASA physical status I-II undergoing elective laparoscopic surgery

**Exclusion criteria:**

patient having any of the following will be excluded from study

–     Patients not giving written informed consent

–     Patients having anticipated difficult airway

–     Duration of surgery > 2 hours

–     Patient weight <30 kg  and >100 kg

–     Any associated neurological disorders, gastrointestinal reflux disease

–     Body mass index ≥30kg/m2

–     Any contraindication to supraglottic airway devices

–     Inadequate fasting, full stomach.pregnancy,reactive airway disease etc.

**Methodology:**

The study will be conducted after getting approval from ethics commitee of King George’s Medical University, Lucknow.  A computer generated system will be used for randomization by creating a list of number each number referred to one of the two groups.

Group A: Patients in which SAD used is LMA Proseal

Group B: Patients in which SAD used is LMA Protector

On arrival in the operating room, patients will be subjected to the standard monitoring like ECG, noninvasive arterial blood pressure, heart rate, temperature and SpO2 and a  baseline vitals parameter will be recorded.

They all  will be  subjected to the same anaesthetic protocol. Induction will be done in supine position with fentanyl( 2 μg/kg )and propofol( 2 mg/kg ) after  3 minute preoxygenation  with 100 %  O2 followed by  muscle relaxant vecoronium (0.1mg/kg ), to facilitate device placement

LMA to be used of size 3,4 or 5 of either device as their size available in both device recommended for same weight group as following:

| | | | | | | | | | | | | |

| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |

|

| | | |

| --- | --- | --- |

|DEVICE

SIZE

WEIGHT RANGE

|LMA proseal

or

LMA Protector

| |

| --- |

|3

|4

|5

| |

| --- |

|30-50 kg

|50-70 kg

|70-100 kg

 All SADs  will be lubricated on back surface of cuff  before insertion. SAD placement will be done after achieving adequate   relaxation.  The time of successful placement of LMA will be defined as the duration from the time anaesthesiologist picks up the LMA till the capnography tracing is obtained. Effective ventilation will be tested by observation of chest wall movement and   capnography curve on the monitor. Ventilation will be set at an inspired tidal volume of 6-8 ml/kg and respiratory rate of 12 minutes,inspiratory expiratory ratio of 1:2 with no PEEP. If there is no chest wall movement and no capnography tracing on monitor, that attempt will be considered as failed.We will also note total no of attempt in each case and no of successful placement in first attempt.  During the procedure  hemodynamic changes will be recorded.

After successful placement of  either device oropharyngeal leak pressure will be measured. For this we will set intracuff pressure of LMA at 60 cm of H2O confirmed by manometer according to manufacturer’s recommendation. Now expiratory valve of circle system will be closed ,keep fresh gas flow at 3 L/min and stop the ventilation. The peak pressure at which leaking from airway device will be confirmed by hearing noisy sound or stethoscope,s then setting will be back to previous normal.

After completion of surgery device will be removed and patient will be shifted to postopearative recovery room. Two hours after surgery patient will be assessed for any airway morbidity by asking him like sore throat(constant pain), dysphonia(hoarseness) or dysphagia. Device  will also be checked for any blood stain  to asses  any trauma during insertion .

All data will be collected and summarized in excel chart and subjected to statistical analysis.

**Statistical Analysis**

The data will be expressed as mean and standard deviation (SD) or median, range and percentage as appropriate. All the categorical data will be compare by using chi square test. Continuous variables in two groups will be compared by t- test. The p-value <0.05 will be considered as significant. The statistical analysis will be done using SPSS 21.0 version (Chicago, Inc., USA) windows software.

  **REVIEW OF LITERATURE**

**Kini G et al (2014)**8 conducted a prospective, randomized study on  48 adult patients of American Society of Anesthesiologists I-II of either gender between 18 and 60 years under general anaethesia. They used I-gel (Group I) or Proseal LMA (Group P)for airway and put on spontaneous mode.   They assessed time taken for device insertion,effective seal, fiberoptic view of larynx,ease of ryle’s tube insertion and sore throat of these two device. Although  time required for insertion of I-gel was lesser (21.98 ± 5.42 and 30.60 ± 8.51 s in Group I and Group P, respectively; *P* = 0.001) but in   Group P number of patients having leak pressure was >20 cm of H2O  were more than  Group I and  rest thing was    comparable and non significant. It was concluded that PLMA has better  suitability and can be used for controlled ventilation

   **Patodi V  et al (2016)9** conducted a prospective randomized on total 60 patients, aged 20-60 years; of ASA grade 1 or 2, 30 in each group, to compare haemodynamic responses, insertion time of device and nasogastric tube and  postoperative complications, if any posted for laparoscopic cholecystectomy under general anaesthesia. The mean time of insertion of PLMA ( 37.40±16.09 seconds) in compare to  intubation  to ETT ( 31.17±20.89 seconds)  was statistically not significant (P >0.05) but time of insertion of nasogastric tube (18.84±6.84 seconds) in PLMA group and 73.00±71.06 seconds in the ETT group  was highly significant, (P <0.001). There was a statistically significant increase in the heart rate(HR),systolic blood pressure (SBP),diastolic blood pressure (DBP) and mean arterial pressure (MAP) at intubation that persisted till 5 minutes of intubation and also at the time of extubation in ETT group, (P <0.05) but not in proseal LMA.(P>0.05).  Study showed ProSeal LMA may be a suitable alternative to endotracheal tube for airway management with stable haemodynamics in patients undergoing laparoscopic cholecystectomy under general anaesthesia.

**Anand LK****et al (2016)10**conducted a prospective randomized  study on  84  patients were randomly allocated to the LMA Supreme group or the LMA ProSeal group to compare OLPs, success rate, insertion time, fiberoptic view of the larynx hemodynamic and respiratory parameters, and complications  at different time points . The mean OLP was significantly lower in the LMA Supreme group than in the LMA ProSeal group (24.9 Â± 5.3 cmH2O vs. 28.4 Â± 5.8 cmH2O;*p* < 0.01). The first attempt success rate and ease of insertion grading for LMA were higher in the Supreme group. The insertion time was lower in the Supreme group than in the ProSeal group (*p* < 0.01). The fiberoptic view was better with the ProSeal LMA. The hemodynamic and ventilatory parameters and postoperative sore throat were comparable in both groups. The LMA ProSeal has a higher OLP than the LMA Supreme. The success rate of first attempt insertion and ease of insertion were better for the LMA Supreme group and the insertion time was lower in the LMA Supreme group. The Supreme and ProSeal LMAs were both effective for positive pressure ventilation in laparoscopic cholecystectomy.

 **Parikh SS** **et al (2017)11**Conducted a prospective, randomized study with 60 patients of ASA grade I/II undergoing elective surgery. The patients were randomly divided into two equal groups to the PLMA group (Group S) and to the ETT group (Group C) Heart rate (HR), mean blood pressure (MAP), ETCO2 values, intraoperative complications such as regurgitation- aspiration, and Postoperative complications such as nausea or vomiting, throat soreness and oral injuries were monitored. There was no difference demographically. Insertion success rate was 100% for both the groups. The mean increase in HR was seen all throughout the duration of the surgery to 8 % above the baseline in Group C and to 3% above the baseline in Group S. On comparing the MAP in Group C, there was a increased by 2.5% to 78.300 ± 14.2615 mmHg as compared to an increase by 5% to 76.233 ± 6.2072 mmHg in Group S. EtCO2.

**Singh A  et al (2018)12** conducted a study on total 84 adult patients undergoing elective surgery were randomly allocated to three groups: group P (PLMA), group I (I-gel) and group S (SLMA) of 28 patients each. Insertion times, number of insertion attempts, haemodynamic response to insertion, ease of insertion of airway device and gastric tube, oropharyngeal leak pressure (OLP) and pharyngolaryngeal morbidity were assessed. The primary outcome measure was the OLP after successful device insertion. OLP measured after insertion, 30 minutes later and at the end of surgery differed significantly between the three groups (*P* < 0.001). The mean OLP was 32.64 ± 4.14 cm·H2O in group P and 29.79 ± 3.70 cm·H2O in group S. In group I, the mean OLP after insertion was 26.71 ± 3.45 cm H2O, which increased to 27.36 ± 3.22 cm H2O at 30 minutes and to 27.50 ± 3.24 cm H2O towards the end of surgery. It was concluded that PLMA provides better sealing but takes longer time to insert

**Gupta R  et al (2019)13** conducted a study that Eighty-eight adult patients scheduled for laparoscopic cholecystectomy under general anesthesia were randomly allocated into two groups group P (using proseal LMA) and group A (using Air-Q Blocker). The primary endpoint was airway seal pressure. Secondarily, we sought to compare overall insertion success, ease of insertion, hemodynamic effects after initial placement, ease of drain tube placement, and perioperative oropharyngolaryngeal morbidity between the devices.  Oropharyngeal seal pressures for AQB and PLMA were 31.5 ± 2.41 and 29.41 ± 2.14 cm H2O, respectively (*P* = 0.01). Insertion time was longer with AQB than PLMA, 25.59 ± 5.71 and 18.66 ± 3.15 seconds, respectively (*P* = 0.001). Ease and success rate of insertion was better with PLMA compared to AQB. Failure of device insertion was seen in 2 cases of Group A.

**Monteserín-Matesanz, C****et al (2020)14** conducted a study on  total 45 patients ASA (American Society Anaesthesiologists) physical status I–II, aged 18–60 years scheduled for elective ambulatory surgery were randomly allocated to receive the SLMA or the PLMA. Sevoflurane ET50 was determined as the midpoint concentration of all the independent pairs that manifested crossover from “movement†to “no movementâ€. The ET50 sevoflurane concentration co-administered with remifentanil required for PLMA insertion was 1.20 ± 0.41% (95% confidence interval 0.76 to 1.63%). For SLMA insertion, it was 0.55 ± 0.38% (95% confidence interval 0.14 to 0.95%) (*p* = 0.019). The end-tidal sevoflurane concentration with co-administered remifentanil required to allow insertion of the SLMA was 54% lower than that needed for inserting the PLMA.

**Reference**

1.     Stauffer JL, Olson DE, Petty TL. Complications and consequences of endotraqueal intubation and tracheotomy. Am J Med. 1981;70:65-76.

2.     Grillo HC, Donahue DM, Mathisen DJ. Postintubation tracheal stenosis. J Thorac Cardiovasc Surg. 1995;109:486-93

3.     Ferdinende P, Kim D. Prevention of postintubation laryngotraqueal stenosis. Acta Otorhinolarymgol Belg. 1995;49:341-6.

4.     Kyle M. Behrens**,** Richard E. Galgon .Supraglottic airway versus endotracheal tube during interventional pulmonary procedures – a retrospective study [BMC Anesthesiology](https://bmcanesthesiol.biomedcentral.com/) volume 19, Article number  : 196 (2019)

5.     Sharma B, Sahai C, Sood J. Extraglottic airway devices: technology update        [published correction appears in Med Devices (Auckl). 2018 Jan 04;11:27]. *Med         Devices (Auckl)*. 2017;10:189-205.

6.     Brain AI, Verghese C, Strube PJ. The LMA ‘Proseal’ – A laryngeal mask with an oesophageal vent. Br J Anaesth. 2000;84:650–4

7.     Tan LZ, Tan DJ, Seet E. Laryngeal mask airway protectorâ„¢: Advanced uses for laparoscopic cholecystectomies. Indian J Anaesth 2017;61:673-5

8.     Kini G, Devanna GM, Mukkapati KR, Chaudhuri S, Thomas D. Comparison of I-gel with proseal LMA in adult patients undergoing elective surgical procedures under general anesthesia without paralysis: A prospective randomized study. J Anaesthesiol Clin Pharmacol 2014;30:183-7

9.     Patodi V, Singh M, Sethi SK, Depal VN, Jain N, Kumar V. A comparative study between ProSeal laryngeal mask airway and endotracheal tube for ease of insertion and haemodynamic changes in patients undergoing laparoscopic cholecystectomy under general anaesthesia. Int J Res Med Sci 2016;4:5334-40.

10.                        Anand LK, Goel N, Singh M, Kapoor D. Comparison of the Supreme and the ProSeal laryngeal mask airway in patients undergoing laparoscopic cholecystectomy: A randomized controlled trial. Acta Anaesthesiol Taiwan. 2016 Jun;54(2):44-50.

11.                        Parikh SS, Parekh SB, Doshi C, Vyas V. ProSeal Laryngeal Mask Airway versus Cuffed Endotracheal Tube for Laparoscopic Surgical Procedures under General Anesthesia: A Random Comparative Study. *Anesth Essays Res*. 2017;11(4):958-963.

12.                        Singh A, Bhalotra AR, Anand R. A comparative evaluation of ProSeal laryngeal mask airway, I-gel and Supreme laryngeal mask airway in adult patients undergoing elective surgery: A randomised trial. Indian J Anaesth 2018;62:858-64

13.                        Gupta R, Mahajan R, Jatinder M, Gulati S, Mehta A, Nazir R. A comparison between ProSeal laryngeal mask airway and Air-Q Blocker in patients undergoing elective laparoscopic cholecystectomy. J Anaesthesiol Clin Pharmacol 2019;35:340-7

14.                        Monteserín-Matesanz, C., González, T., Anadón-Baselga, M.J. et al. Supremeâ„¢ laryngeal mask airway insertion requires a lower concentration of sevoflurane than ProSealâ„¢ laryngeal mask airway insertion during target-controlled remifentanil infusion: a prospective randomised controlled study. BMC Anesthesiol 20, 5 (2020).

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-07
• Last Update Posted: 2022-06-29

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Patients of either sex aged 18-60 years of ASA physical status I-II undergoing elective laparoscopic surgery.

Exclusion Criteria

Patient having any of the following will be excluded from study Patients not giving written informed consent, Patients having anticipated difficult airway, Duration of surgery > 2 hours , Patient weight <30 kg and >100 kg, Any associated neurological disorders, gastrointestinal reflux disease, Body mass index ≥30kg/m2, Any contraindication to supraglottic airway devices, Inadequate fasting, full stomach.pregnancy,reactive airway disease etc.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
After completion of surgery device will be removed and patient will be shifted to postopearative recovery room. Two hours after surgery patient will be assessed for any airway morbidity by asking him like sore throat(constant pain), dysphonia(hoarseness) or dysphagia. Device will also be checked for any blood stain to asses any trauma during insertion .	48hrs to 72 hrs

Secondary Outcome Measures

Name	Time	Method
For this we will set intracuff pressure of LMA at 60 cm of H2O confirmed by manometer according to manufacturer’s recommendation. Now expiratory valve of circle system will be closed ,keep fresh gas flow at 3 L/min and stop the ventilation	24 hrs

Trial Locations

Locations (1)

Department of Anaesthesiology; 🇮🇳 Lucknow, UTTAR PRADESH, India

Department of Anaesthesiology

🇮🇳Lucknow, UTTAR PRADESH, India

Prof BB Kushwaha

Principal investigator

9140398527

brij_kushwaha00634@yahoo.com