BLK-MAX PPT Template (2).pptx a pilot study to see the effect of PEEP on airleak and oxygenation while using proseal LMA in laparoscopic cholecystectomy surgeries

pilot study

1. CANDIDATE DR PRATIMA SINGH        GUIDE CO-GUIDE DR.U.K. Valecha, MD Dr. Sharwan Mittal Dr. Rajesh Gupta Senior director & HOD Senior consultant Senior consultant Department of Anaesthesia Department of Anaesthesia Department of Anaesthesia A PILOT STUDY TO SEE THE EFFECT OF POSITIVE END EXPIRATORY PRESSURE ON AIR LEAK AND OXYGENATION WHILE USING PROSEAL-LARYNGEAL MASK AIRWAY IN LAPAROSCOPIC CHOLECYSTECTOMY SURGERIES .

2. INTRODUCTION The use of laryngeal mask airway (LMA) has revolutionized the practice of anaesthesia with its advantages of reduced airway handling and airway associated morbidity. Multiple trials (1,2) have confirmed the safety of the LMA for both spontaneous respiration and controlled ventilation. Use of Positive end expiratory pressure (PEEP) is recommended for better oxygenation during general anaesthesia. However, there are concerns that application of PEEP with LMA may result in significant gas leak. Invention of Proseal-LMA mask in which there is a port for Ryle’s tube helps in preventing gastric insufflation, suction of gastric contents and prevention of pulmonary aspiration. Various studies have been conducted in which Proseal-LMA mask was used instead of endotracheal tube in elective surgeries under general anaesthesia. However, very few studies are there in which gas leak and oxygenation was observed while using LMA mask for conducting laparoscopic surgeries. Therefore we designed this prospective randomized study to see the effect of PEEP on gas leak and oxygenation while using Proseal-laryngeal mask airway in laparoscopic cholecystectomy surgeries.

3. AIMS AND OBJECTIVES   AIMS To see the effect of positive end expiratory pressure on air leak and oxygenation while using P roseal-laryngeal mask airway in laparoscopic cholecystectomy surgeries.     Primary objective - 1) To measure and compare air leak ( ΔVt ) before and after application of PEEP v s ZEEP. 2) To measure and compare oxygenation(SpO2 ) before and after application of PEEP vs ZEEP. Secondary objective - 1) To note if any patient requires endotracheal intubation in either group . 2) To find number of attempts used in setting Proseal-LMA in either group. 3) To study the effect of PEEP on postoperative oxygenation(SpO 2 ) .

4. MATERIALS AND METHODS STUDY SITE - DR B L KAPUR MEMORIAL HOSPITAL, PUSA ROAD, DELHI STUDY POPULATION- Study will be conducted in patient’s age above 18 years With (ASA-I, II) undergoing laparoscopic cholecystectomy STUDY DESIGN - Prospective Randomized study Time frame to address this study -October 2022 to September 2023 Sample size - Hannah Ullmann et al., 2022 reported the incidence of gas leakage to be 13.2% in the ZEEP group as against 20.2% in the PEEP group. Assuming these as reference values, the minimum required sample size at 5% level of significance and 80% power is obtained as at least 442 patients in each group .

5. Formula used- n = where n is the number of subject required in each group p 1 is the incidence of death in the Dexamethasone group p 2 is the incidence of death in the usual care group is cumulative normal distribution at α/2 level of significance is cumulative normal distribution at β value (where power = 1 - β )

6. Formula used : p1 = 0.132 p2 = 0.202 z 2.5% = 1.96 at α = 5% level of significance z β = 0.842 at β = 20% value (where power = 1 - β = 80%) n =

7. MATERIALS AND METHODS Keeping in mind our hospital patient load and limited study time period we are going to take 120 participants in each group . Statistical Tests: The quantitative variables in both groups will be expressed as mean±SD and compared using Unpaired Student t-test. The qualitative variables will be expressed as frequencies/percentages and compared using chi-square test. A p-value < 0.05 will be considered statistically significant. IBM Statistical Package for Social sciences (SPSS) version 20.0 will be used for statistical analysis.

8. PATIENT SELECTION CRITERIA INCLUSION CRITERIA – 1- Patients more than 18 years of age with American Society of Anaesthesiology (ASA I & II) 2 - Patients for laparoscopic cholecystectomy surgeries under general anaesthesia using Proseal-LMA EXCLUSION CRITERIA - 1-Patients not giving consent. 2- Patients belonging to ASA III & more. 3- Patients at increased risk of aspiration. 4- Patients at gastro-esophageal reflux disease (hiatus hernia) 5- Pregnant females 6- Patients with psychiatric disorder 7- Morbidly obese patients

9. METHODOLOGY- After approval from hospital ethical committee and obtaining written informed consent, patients meeting inclusion criteria will be included in the study. -Pre-anaesthetic checkup will be done. -All routine investigation will be done. GROUP ALLOCATION- patients will be randomized into 2 groups, group A and group B. Randomization will be done using computer generated chart with allocation ratio of 1:1 into any of the 2 groups. Group A: (n= 120) will be receiving PEEP of 6 cmH 2 O Group B: (n= 120) will be receiving ZEEP (Zero PEEP)

10. OBSERVATIONS 1 ) Peri Proseal-LMA leak (ΔVt) will be noted before application of PEEP and after application of PEEP vs ZEEP. 2 ) Oxygen saturation(SpO2) will be noted before application of PEEP and at 5mins , 15mins and 25 mins after application of PEEP vs ZEEP . 3) SpO2 will be noted in post anaesthesia care unit after one hour of shifting . 4 ) Number of attempts in setting Proseal-LMA will be noted . 5) Patients in whom endotracheal intubation will be required will be noted.

11. STUDY PROFORMA MRD No: Date : Name: Height : meters Age: years Weight : kg Sex: M/F BMI : kg/m 2 PREOPERATIVE Pulse: Blood Pressure: Respiratory Rate : SpO 2 : Temperature: Serum creatinine: Coagulation profile:

12.   Parameters Before pneumoperitonium After pneumoperitonium Postoperative SpO2 after 1 hour ZEEP PEEP ZEEP PEEP       Leak around LMA (ΔVt)         SpO2 at FiO2(0.5 )     5mins 15mins 25mins 5mins 15mins 25mins               No.of attempts in setting P-LMA       Intubation required or not

13. 1. Hannah Ullmann, Laura Renziehausen, Dominik Geil,  Christoph Sponholz,  Daniel Thomas- Rüddel Maria Theresa Völker,  Uta Pietsch,  Natalie Krug,  Sven Bercker:   The Influence of Positive End-Expiratory Pressure on Leakage and Oxygenation Using a Laryngeal Mask Airway: A Randomized Trial :Anesth Analg 2022 Oct 1;135(4):769-776. 2 . Keller C, Brimacombe J. [Spontaneous versus controlled respiration with the laryngeal mask. A review]. Anaesthesist. 2001;50:187–191 3. V on Goedecke A, Brimacombe J, Keller C, et al. Positive pressure versus pressure support ventilation at different levels of PEEP using the ProSeal laryngeal mask airway. Anaesth Intensive Care . 2004;32:804–808. 4.Doo-Hwan Kim   ,  Jun-Young Park   ,  Jihion Yu   ,  Gi-Ho Koh n ,  Eunkyul Kim   ,   Jai-Hyun Hwang,  Young-Kug Kim .   Positive end-expiratory pressure increases arterial oxygenation in elderly patients undergoing urological surgery using laryngeal mask airway in lithotomy position . Randomized controlled trial : J C lin M onit Comput2020 Feb;34(1): 161-169 . 5.Souvik Maitra,  Dalim K Baidya,  Mahesh K Arora,  Sulagna Bhattacharjee,  Puneet Khanna . Laryngeal mask airway ProSeal provides higher oropharyngeal leak pressure than i-gel in adult patients under general anesthesia: a meta-analysis. J Clin anesth  2016 Sep;33:298-305. REFERENCES  

14. PATIENT INFORMATION SHEET STUDY TITLE -EFFECT OF POSITIVE END EXPIRATORY PRESSURE ON AIR LEAK AND OXYGENATION WHILE USING PROSEAL-LARYNGEAL MASK AIRWAY IN LAPAROSCOPIC CHOLECYSTECTOMY SURGERIES : A RANDOMIZED STUDY STUDY SITE - Dr. B. L. Kapur Memorial Hospital, Pusa Road, New Delhi – 110005 Name of principal investigator/Guide : 1) Dr. Sharwan Mittal MBBS DA, DNB Senior Consultant Department of Anaesthesia Dr. B. L. Kapur memorial Hospital Pusa road, New Delhi Co-investigators(2nos ) : 1) Dr. Pratima Singh( Thesis Scholar-cum-Co investigator#1) DNB Post Diploma Trainee Anaesthesiology Department of Anaesthesia Dr. B. L. Kapur Memorial Hospital Pusa Road, New Delhi Contact No.: [phone]   2 ) DR RAJESH GUPTA (co-guide-cum-co-investigator) MBBS DA DNB SENIOR CONSULTANT DEPARTMENT OF ANAESTHESIA DR. B. L. KAPUR MEMORIAL HOSPITAL, PUSA ROAD, NEW DELHI

15. Information leaflet- You are invited to take part in this research project “- EFFECT OF POSITIVE END EXPIRATORY PRESSURE O N AIR LEAK AND OXYGENATION WHILE USING PROSEAL-LARYNGEAL MASK AIRWAY IN LAPAROSCOPIC CHOLECYSTECTOMY SURGERIES : A RANDOMIZED STUDY   Before you decide whether or not to take part, it is important for you to understand why this study is being done and what it will involve. Please take time to read this information sheet carefully and discuss it with family or friends if you wish so. You are requested to contact the investigator for more information (see the contact details at the end of this information sheet). Thank you for your participation . Aim of the study: The aim of the study is to study the effect of positive end expiratory pressure on air leakage and oxygenation while using a Proseal-LMA in laparoscopic cholecystectomy surgeries.   What harm it may do? Using of Proseal-LMA is absolutely safe. Addition of PEEP does not cause any harm rather it is beneficial for improvement of oxygenation. What is the study about? The study to see the effect of positive end expiratory pressure in leakage and oxygenation using a Proseal-LMA in laparoscopic cholecystectomy.

16. Do I have to pay for it? NO   How it will be done? It is an observational study in which we will observe the effect of PEEP on leak around the laryngeal mask airway cuff and oxygenation. Will my participation in the study be kept confidential? Yes, all the information regarding you and your health will be kept confidential. Researcher assume to keep your information confidential. The results when published will not reveal your identity. Can I refuse? Yes ,participation is entirely voluntary Is the study safe? Previous studies have shown that application of PEEP in Proseal-LMA is absolutely safe and standard of care.   Your Responsibility 1- You shall provide accurate and detailed information of your medical and treatment history to investigator. 2- If any adverse effect occur after procedure you shall immediately inform the appropriate details to the investigators . For further information you are requested to contact. Dr. PRATIMA SINGH

17. INFORMED CONSENT FORM I …………………………………. S/D/W ………………………………………………...... R/o ………………………………………………………………….………… I have been informed that “ EFFECT OF POSITIVE END EXPIRATORY PRESSURE ON AIR LEAK AND OXYGENATION WHILE USING A LARYNGEAL MASK AIRWAY IN LAPAROSCOPIC CHOLECYSTECTOMY SURGERIES : A RANDOMIZED STUDY” is being carried out, which will be used to treat me/my relative. I have been given the chance to discuss the study and ask questions. I consent that the information from my clinical progress may be used in the study. I have been informed about the purpose and nature of the procedure in the language that I understand and to my full satisfaction by DR. PRATIMA SINGH. I have also been informed about the side effects and the procedure to be performed. I realise that this is being done to provide better oxygenation and better outcome during general anaesthesia in laparoscopic surgery and thereby determine the appropriate PEEP to be used. I voluntarily give my full consent to be enrolled in this study and also secured my rights to withdraw from the study whenever I wish without prejudice. Patient/ Patient’s relative signature Signature of Witness   Or thumb impression Name:   Name: Date:   Date: Signature of investigator:

18. THANK YOU