FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/03/051160 [Registered on: 29/03/2023] Trial Registered Prospectively
Last Modified On: 23/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To study the comparison of video assisted intubation through LMA protector and i-gel. 
Scientific Title of Study   Comparison of fibreoptic guided tracheal intubation through LMA protector and i-gel in adult paralysed patients 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mamta Bhardwaj 
Designation  Professor 
Affiliation  Pt B.D. Sharma PGIMS 
Address  Department of anaesthesiology and critical care Pt B.D. Sharma PGIMS Rohtak

Rohtak
HARYANA
124001
India 
Phone  9812789476  
Fax    
Email  drbmamta@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  M karthik 
Designation  Postgraduate student  
Affiliation  Pt B.D. Sharma PGIMS 
Address  Department of anaesthesiology and critical care Pt B.D. Sharma PGIMS Rohtak

Rohtak
HARYANA
124001
India 
Phone  8220832202  
Fax    
Email  karthik.ders@gmail.com  
 
Details of Contact Person
Public Query
 
Name  M karthik  
Designation  Postgraduate student  
Affiliation  Pt B.D. Sharma PGIMS 
Address  Department of anaesthesiology and critical care Pt B.D. Sharma PGIMS Rohtak

Rohtak
HARYANA
124001
India 
Phone  8220832202  
Fax    
Email  karthik.ders@gmail.com  
 
Source of Monetary or Material Support  
Pt B.D. Sharma PGIMS 
 
Primary Sponsor  
Name  Department of anaesthesiology and critical care  
Address  2nd floor , Modular building complex Pt B.D. Sharma PGIMS Rohtak 
Type of Sponsor  Government medical college 
 
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 
karthik  Pt B.D. Sharma PGIMS  Department of anaesthesiology and critical care, 2nd floor Modular building complex, Pt B.D. Sharma pgims, Rohtak
Rohtak
HARYANA 
8220832202

karthik.ders@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Biomedical research ethics committee   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  i-gel   Comparison of fibre optic guided tracheal intubation through LMA protector versus i-gel in adult paralysed patients Total duration of intervention:3 to 5 minutes  
Comparator Agent  Laryngeal mask airway protector   Comparison of fibreoptic guided tracheal intubation through LMA protector versus i-gel in adult paralysed patients Total duration of intervention:3 to 5 minutes  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients of either sex from age 18 to 70 years belonging to American society of anaesthesiologists (ASA) physical status1 or 2 scheduled for elective surgery under general anaesthesia will be included. 
 
ExclusionCriteria 
Details  Patients with
Anticipated difficult airway
BMI >35kg/sq.meter
Inter incisor distance of <3.2 cm
Pregnancy
Known gastro esophageal reflex
Upper airway pathology
Surgical procedures involving oral cavity or in prone position
Recent upper respiratory tract infection
Patients refusal  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Fibreoptic guided total tracheal intubation time   At 0 minute, before start of surgery at the time of anaesthesia induction  
 
Secondary Outcome  
Outcome  TimePoints 
Mean time of insertion
Ease of insertion
Oropharyngeal leak pressure
Fibreoptic view of placement
Adverse effects 
Baseline
baseline
Baseline
10 minutes
At 1 hour and 24 hours after surgery
 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "66"
Final Enrollment numbers achieved (India)="66" 
Phase of Trial   N/A 
Date of First Enrollment (India)   31/03/2023 
Date of Study Completion (India) 15/11/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 15/11/2023 
Estimated Duration of Trial   Years="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Providing a safe airway is the prime responsibility of an anaesthesiologist. Supra glottic airway devices (SAD) are being widely used for airway management in the anaesthetic field, critical care and emergency situations. Since the introduction of the first generation classic laryngeal mask airway (cLMA), the evolution in supraglottic airway designs has been a continuous process. Second generation SADs incorporate a second drainage tube to enhance the safety of supraglottic airway devices. In current scenario they are not only used as a ventilating device but also act as conduit for planned blind as well as fiberoptic guided intubation in anticipated or unanticipated difficult laryngoscopies.i-gel (Intersurgical, Berkshire, UK) is a promising second-generation SAD which has gained popularity over last decade because of its anatomical shape and gel filled cuff. The airway channel of i-gel is shorter and wider compared to that of the other SADs, allowing the adult size endotracheal tube to easily pass through it. Its large bowl, better alignment with glottis along with the absence of aperture bars makes i-gel a favorable conduit for fibreoptic-guided tracheal intubationThe LMA Protector (Teleflex Medical Europe Ltd., Athlone, Ireland) is a recently introduced, second-generation SAD with design features that minimizes the risk of gastric aspiration. In comparison to the i-gel, there are two gastric drainage tubes on either side of the ventilation channel and an enlarged air inflatable cuff.In addition,the airway lumen of the LMA Protector is wide enough to pass an adequately sized tracheal tube. Hence, LMA Protector can be used as a conduit for fibreoptic-guided tracheal  intubation.As there is no previous randomized trial primarily comparing fibreoptic-guided tracheal intubation via the LMA Protector with i-gel using polyvinyl chloride ( PVC ) endotracheal tube. So, we planned the current study to compare fibreoptic-guided tracheal intubation through the i-gel with the LMA Protector using PVC ETT.

 
Close