To Compare airway devices in laparoscopic cholecystectomy procedure

Not yet recruiting

• Conditions: Cholecystitis, unspecified,

• Registration Number: CTRI/2023/12/060599
• Lead Sponsor: Department of Anaesthesiology

Brief Summary

**Backgroundand Rationale**

Securing the airway is one of the primary concern of anaesthesiologistin patient undergoing surgery in general anaesthesia. Tracheal intubation hasbeen for years the technique of choice for airway management during surgicalprocedures under general anesthesia. However, it is not a procedure withoutrisk and limitation. Besides technical challenges in tube placement there aresome complication that range from events such as trauma in airway,laryngospasm,laryngeal edema, to other minor events such as hoarseness of voice andpostoperative sore throat. There have been very limited studies comparing theLMA Blockbuster and Baska mask. Therefore, the aim of this study is to comparethe effectiveness of the LMA blockbuster and the Baska mask in terms of ease ofinsertion, quality of ventilation, oropharyngeal leak pressure and incidence ofpost-operative complications. We hypothesized that the Baska mask wouldwithstand higher inflation pressure with the cuffless membranous bowl withouthaving a problem with diffusion of nitrous oxide, have faster placement time withless laryngopharyngeal morbidity in postoperative period as compared to LMABlockbuster in patients undergoing elective surgeries for laparoscopiccholecystectomy.

Importance of the research proposal: The study will beable to provide better option for laparoscopic cholecystectomy procedures

**ResearchHypothesis:**

·        Thereshould be a significant difference in outcomes of patients undergoinglaparoscopic cholecystectomy using LMA Blockbuster and Baska mask.

**OBJECTIVES**

**PrimaryObjective:**

·        Tocompare oropharyngeal leak pressure (OLP) between Baska mask and LMABlockbuster in patients undergoing laparoscopic cholecystectomy.

**SecondaryObjective:**

·        Easeof insertion

·        Haemodynamicparameters

·        Complicationsduring insertion like laryngospasm, trauma and blood staining

·        Post-operativeairway morbidity (hoarseness of voice, sore throat, dysphagia)

 **Studydesign and methods:**

**StudySettings:**

Thestudy will be conducted in Department of Anaesthesiology in collaboration ofgeneral surgery department of King George’s Medical University, Lucknow after takingwritten and informed consent from the patients.

**Studydesign:**

Prospective,Randomized, Comparative study.

**Studyduration:** One year

**Samplesize**: Total 86cases included in the study

**Inclusion and exclusion criteria:**

**Inclusion Criteria:**

• Patients of either sex

• Aged 18-60 years

• ASA physical status I-II

• Undergoing elective laparoscopiccholecystectomy of less than 2hrs

**Exclusion criteria:**

·        Patientsnot giving written informed consent

·        Patientshaving anticipated difficult airway

·        Interincisor distance < 2.5 cm

·        Anyassociated neurological disorders, gastroesophageal reflux disease

·        Bodymass index ≥30kg/m2

·        Anycontraindication to supraglottic airway devices

·        Inadequatefasting, full stomach, pregnancy, reactive airway disease etc.

**Sample size:**

Samplesize is calculated on the basis of proportion of ease of insertion in BaskaMask and LMA Blockbuster groups using the formula

  Wherep1 = 0.58 (58%) proportion of ease of insertion in Baska Mask group p2 = 0.76(76%) proportion of ease of insertion in LMA Blockbuster group e = 0.25(p1/p2),the risk ratio considered to be clinically significant Type I error, α=5% TypeII error β=10% for detecting results with power of study 90%

 Thesample size is n = 43 each group

*(Chaudhary UK, Mahajan SR,Mahajan M, Sharma C, Sharma M. A comparative analysis of the baska mask versusI-gel for general anesthesia in surgical patients undergoing laparoscopiccholecystectomy. Acta Med Int 2018;5:69-73)*

**METHODOLOGY:**

The study will be conducted aftergetting approval from ethics committee of King George’s Medical University,Lucknow. A computer-generated system will be used for randomization by creatinga list of number each number referred to one of the two groups.

Group A: Patients in which SADused is Baska mask

Group B: Patients in which SADused is LMA Blockbuster

On arrival in the operating room,patients will be subjected to the standard monitoring like ECG, noninvasiveblood pressure, heart rate, temperature and SpO2 and a baseline vitalsparameter will be recorded.

They all will be subjected to thesame anaesthetic protocol. Induction will be done in supine position withfentanyl (2 mcg/kg) and propofol (2 mg/kg) after 3-minute preoxygenation with100 % O2 followed by muscle relaxant vecoronium (0.1mg/kg), to facilitatedevice placement Baska mask, LMA Blockbuster to be used of size 3,4 no. ofeither device as their size varies according to weight of the patient.

All SADs will be lubricated onback surface of cuff before insertion. SAD placement will be done afterachieving adequate relaxation. The time of successful placement of LMA will bedefined as the duration from the time anesthesiologist picks up the LMA tillthe capnography tracing is obtained. Effective ventilation will be tested byobservation of chest wall movement and capnography curve on the monitor.Ventilation will be set at an inspired tidal volume of 6-8 ml/kg andrespiratory rate of 12 minutes, inspiratory expiratory ratio of 1:2 with noPEEP. 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 ofattempt in each case and no. of successful placement in first attempt. Duringthe procedure hemodynamic changes will be recorded. The study will be able toprovide better option for laparoscopic cholecystectomy procedures.

After successful placement ofeither device oropharyngeal leak pressure will be measured. OLP test will beperformed after the loss of spontaneous respiration. The OLP is defined as theplateau airway pressure reached with the fresh gas flow at the rate of 6lit/min and pressure adjustment valve set to 70 cm H20. The peak pressure atwhich leaking from airway device will be confirmed by hearing noisy sound orstethoscope then setting will be back to previous normal.

After completion of surgerydevice will be removed and patient will be shifted to postoperative recoveryroom. Two hours after surgery patient will be assessed for any airway morbidityby asking him like sore throat (constant pain), dysphonia(hoarseness) ordysphagia. Device will also be checked for any blood stain to assess any traumaduring insertion.

We had assessed and recorded OLP just after and 30 min after insertion ofthe device. It will be determined by closing the expiratory valve at a fixedgas flow of 5 L/min and recording the airway pressure at which equilibrium willbe reached. The airway pressure will be not allowed to exceed 40 cm of water.We also assessed the time taken for insertion of device, i.e., ease ofinsertion, i.e., easy insertion – insertion at first attempt with noresistance; difficult insertion – insertion with resistance or at secondattempt; and failed insertion – insertion not possible even after two attempts.Manipulations will be done in the form of increasing the depth of insertion;giving jaw thrust or changing size of the device. For standardization,intra-abdominal pressure (IAP) will be maintained at 12–16 mmHg. We alsoassessed gastric tube insertion time. The PAP, leak fraction, hemodynamicresponses (heart rate and mean arterial blood pressure), SPO2 andend tidal carbon dioxide (EtCO2)will be also recorded at 1 min afterinduction (T1), 5 min before carboperitonium (T2), 5 min after carboperitonium(T3), 5 min before removal of carboperitonium (T4), and 5 min after removal ofcarboperitonium (T5) along with the baseline (T0) value. To maintain target SPO2(>95%) and EtCO2 (<45 mm Hg) by adjusting the fraction ofinspired oxygen, respiratory rate, and tidal volume. When SPO2 was94%–90%, the oxygenation will be graded as suboptimal, and the oxygenation willbe graded as failed if SPO2 was <90%. The leak fraction will be calculatedby the formula: tidal volume inspires − tidal volume expired/tidal volumeinspired (Vinsp − Vexp/Vinsp) × 100 to assess the device stability. Incidenceof gastric distension/desaturation/aspiration/cough/any lip, tongue, and dentalinjury will be recorded. Postoperative laryngo-pharyngeal morbidity (pain inthroat/change of voice/difficulty in swallowing) will be assessed after 2 h ofremoval of the device. The study will be able to provide better option forlaparoscopic cholecystectomy procedures.

**Statistical analysis:**

All data willbe  statistically analyzed using SPSSstatistical software, Version 22nd.  The quantitative data (OLP, times forinsertion of SGA and gastric tube) will be analyzed using the one-way analysisof variance test and Bonferroni *post hoc* multiple comparison test.Qualitative data (ease of insertion of SGA and gastric tube, first attemptinsertion success rate, number of insertion attempts, and any complications)will be compared using Chi-squared or Fisher’s exact test. A *P* <0.05 was considered significant.

References:

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

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

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

4. Kyle M.Behrens,Richard E. Galgon .Supraglottic airway versus endotracheal tube duringinterventional pulmonary procedures – a retrospective study BMC Anesthesiologyvolume 19, Article number : 196 (2019)

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

6. JJ Gatward, TM Cook, C Seller, J Handel, TSimpson, V Vanek, F Kelly. Evaluation of the size 4 i-gel in one hundrednon-paralysed patients. Anaesthesia 63 (10), 1124-1130, 2008

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-12-19
• Study Start: 2023-12-31

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

Patients of either sex Aged 18-60 years ASA physical status I-II Undergoing elective laparoscopic cholecystectomy of less than 2hrs.

Exclusion Criteria

Patients not giving written informed consent Patients having anticipated difficult airway Inter incisor distance < 2.5 cm Any associated neurological disorders, gastroesophageal 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: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare oropharyngeal leak pressure (OLP) between Baska mask & LMA Blockbuster in patients undergoing laparoscopic cholecystectomy.	48hrs

Secondary Outcome Measures

Name	Time	Method
Ease of insertion	Haemodynamic parameters

Trial Locations

Locations (1)

King George’s Medical University; 🇮🇳 Lucknow, UTTAR PRADESH, India

King George’s Medical University

🇮🇳Lucknow, UTTAR PRADESH, India

Dr Ahshan Khaliq Siddiqui

Principal investigator

7052228963

ahsansiddiqui@kgmcindia.edu