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CTRI Number  CTRI/2024/01/061261 [Registered on: 09/01/2024] Trial Registered Prospectively
Last Modified On: 04/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To compare intubation through Intubating Laryngeal mask airway and Laryngeal mask airway Protector during airway management. 
Scientific Title of Study   Comparison of Intubating Laryngeal mask airway with that of LMA Protector during airway management in adult patients. A prospective randomized comparative study. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR PEDIREDDY SOBHA RANI 
Designation  PG RESIDENT  
Affiliation  IMS AND SUM HOSPITAL  
Address  DEPARTMENT OF ANAESTHESIOLOGY,FIRST FLOOR IMS AND SUM HOSPITAL SIKSHA O ANUSANDHAN UNIVERSITY K8-KALINGA NAGAR, KHORDHA BHUBANESWAR
DEPARTMENT OF ANAESTHESIOLOGY,FIRST FLOOR IMS AND SUM HOSPITAL K8-KALINGA NAGAR, KHORDHA BHUBANESWAR
Khordha
ORISSA
751003
India 
Phone  8790831687  
Fax    
Email  pedireddyshoba78@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sulochana Dash 
Designation  Professor 
Affiliation  IMS AND SUM HOSPITAL  
Address  DEPARTMENT OF ANAESTHESIOLOGY,FIRST FLOOR IMS AND SUM HOSPITAL SIKSHA O ANUSANDHAN UNIVERSITY K8-KALINGA NAGAR, KHORDHA BHUBANESWAR
DEPARTMENT OF ANAESTHESIOLOGY,FIRST FLOOR IMS AND SUM HOSPITAL K8-KALINGA NAGAR, KHORDHA BHUBANESWAR
Khordha
ORISSA
751003
India 
Phone  9566841303  
Fax    
Email  Dr.silu76@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR PEDIREDDY SOBHA RANI 
Designation  PG RESIDENT  
Affiliation  IMS AND SUM HOSPITAL 
Address  DEPARTMENT OF ANAESTHESIOLOGY,FIRST FLOOR IMS AND SUM HOSPITAL SIKSHA O ANUSANDHAN UNIVERSITY K8-KALINGA NAGAR, KHORDHA BHUBANESWAR
DEPARTMENT OF ANAESTHESIOLOGY,FIRST FLOOR IMS AND SUM HOSPITAL K8-KALINGA NAGAR, KHORDHA BHUBANESWAR
Khordha
ORISSA
751003
India 
Phone  8790831687  
Fax    
Email  pedireddyshoba78@gmail.com  
 
Source of Monetary or Material Support  
DEPARTMENT OF ANAESTHESIOLOGY IMS AND SUM HOSPITAL 
 
Primary Sponsor  
Name  IMS AND SUM HOSPITAL  
Address  DEPARTMENT OF ANAESTHESIOLOGY,FIRST FLOOR IMS AND SUM HOSPITAL SIKSHA O ANUSANDHAN UNIVERSITY K8-KALINGA NAGAR, KHORDHA  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR PEDIREDDY SOBHA RANI  IMS AND SUM HOSPITAL  Department of Anesthesiology ,First floor,K8,Kalinganagar Bhubaneswar
Khordha
ORISSA 
8790831687

pedireddyshoba78@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE ,IMS AND SUM HOSPITAL  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Intubating Laryngeal mask Airway  To compare the ease of intubation and time taken for intubation,adequacy of airway seal,oropharyngeal leak pressure,ease of gastric tube placement,incidence of post operative sore throat.Total duration of study 1.5years 
Comparator Agent  Laryngeal mask airway Protector  To compare the ease of intubation and time taken for intubation,adequacy of airway seal,oropharyngeal leak pressure,ease of gastric tube placement,incidence of post operative sore throat 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Adult patient between the age of 18 – 60 years
2.ASA grade one and two
3.Patient is posted for elective surgery under general anesthesia.
 
 
ExclusionCriteria 
Details  1.Age more than 60 years
2.ASA grade three and four
3.Patients with maxillofacial trauma and anomalies
4.Patients with restricted neck movements
5.Obesity BMI more than 40kg/m2
6.Limited mouth opening
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare ease of intubation, number of attempts and time taken for intubation through Intubating laryngeal mask airway and Laryngeal mask airway protector  Time at insertion of Laryngeal mask airway taken as Time 0
Time taken for insertion of ET tube through Laryngeal mask airway is noted
Appearence of capnograph is taken as endtime  
 
Secondary Outcome  
Outcome  TimePoints 
To compare ease of insertion of SAD, adequacy of airway seal, oropharyngeal leak pressure, ease of gastric tube placement, incidence of post-operative sore throat.  Oropharyngeal leak pressures at time of insertion & 10 mins after insertion
post operative 2hour vitals & sore throat within 24hs monitoring. 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   15/01/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

               This study will be conducted at our institution over a period of 1.5 years. In this study 80 ASA grade I and II patients between age 18 to 60 years with BMI<35kg/m2 posted for elective surgeries requiring general anesthesia will be included. After taking written informed consent patients will be randomized to two groups (n=80) by computer generated random number table by the anaesthesiologist who is not involved in the procedure. All patients will be thoroughly examined pre-operatively including detailed airway examination and ASA grading. Patients will be kept Nil per oral from night before surgery. Patients will be shifted to the operation room (OR) on the day of surgery. Intravenous (IV) line will be secured with 18G IV cannula. ASA standard monitors eg. electrocardiograph (ECG), Noninvasive blood pressure (NIBP) and Arterial oxygen saturation (SpO2) will be attached and all patients will be premeditated with IV glycopyrrolate 0.05mg/kg and IV midazolam 0.03 mg/kg, 10 minutes before induction of anaesthesia. 

                 

                Induction will be done with IV fentanyl 2mcg/kg and IV propofol 2.5 mg/kg. After assessing adequate mask ventilation, muscle relaxation will be facilitated with atracurium 0.5 mg/kg, mask ventilation will be continued for 3 minutes. Then according to allocated group proper size SAD will be selected as per body weight. Both devices will be lubricated using 2% lignocaine jelly and the both SAD fully deflated prior to insertion. ILMAâ„¢ or LMA P will be inserted in neutral neck position. After SAD insertion, confirmation of successful ventilation will be confirmed by continuous square waveform capnography. The numbers of attempts and time required for SAD insertion will be recorded. A failed attempt was defined as removal of the SAD from the mouth before reinsertion. After achieving successful ventilation with SAD, blind ET intubation was attempted using both the devices. If no resistance is felt ET tube will be advanced fully into the SAD. 

                  

                When resistance is felt during ET tube insertion, following maneuvers will be tried in LMA P group: 1) Twisting of the ET tube to align the bevel, up and downward movement of the ET tube gently within the SAD. 2) Application of cricoid pressure (Bhandari G et al. [6]). If resistance is felt during insertion of ET tube in ILMA group, a standardized algorithm [4] will be followed on the basis of the distance at which the resistance is felt and other maneuvers which can be includes: optimizing the airway, rotating the ET tube bevel, adjusting head neck position and adding air to the cuff. Duration of successful ET intubation through SAD is defined as the time elapsed from picking of the ET tube by hand and placing it through SAD until confirmation of square waveform capnography (ETCo2). Airway seal will be checked as: Excellent -No audible leak, Good-Some audible leak present, but ventilation is adequately maintaining ETCO2<40mm/Hg. Poor-Relevant loss of air with insufficient ventilation requiring reposition of devices. Orogastric tube placement will be done using SAD. Easily passing gastric tube through SAD will be confirmed by suctioning of gastric contents. 

                

                In all patients, procedure will be performed by the same experienced anaesthesiologist who has done a minimum 50 successful SAD insertions. Ease of insertion, No. of attempts, time taken for ETT placement through ILMA and LMA P will be recorded. Adequacy of airway seal and oropharyngeal leak pressure will be noted for analysisAnaesthesia will be maintained with Isoflurane (1 vol%) in oxygen/nitrous oxide (50%/50%) mixture using closed circuit in low flow (1lit). Intermittent bolus of atracurium for muscle relaxation and fentanyl for analgesia will be used. Inta operative monitoring of vitals, Input output charting will be done. 

 

                At the end of surgery, neuromuscular blockade is reversed with a mixture of glycopyrrolate (0.01 mg/kg) and neostigmine (0.05 mg/kg) and extubation will be done after adequate reversal. Patient will be shifted to recovery room for 30mins observation. Post-operative monitoring, anlgesia and PONV prophylaxis will be given. In post-operative period two hours vitals monitored and patients asked about post operative sore throat incidence in 24hrs and noted for analysis.

 

 
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