FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2021/11/037891 [Registered on: 10/11/2021] Trial Registered Prospectively
Last Modified On: 08/11/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Measuring ease of intubation with ILMA and 2 types of endotracheal tubes  
Scientific Title of Study   COMPARISION OF EASE OF ENDOTRACHEAL INTUBATION WITH POLYVINYL CHLORIDE ENDOTRACHEAL TUBE AND REINFORCED TUBE THROUGH THE INTUBATING LARYNGEAL MASK AIRWAY IN ADULT PATIENTS UNDERGOING SURGERIES UNDER GENERAL ANAESTHESIA 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Devaki Kalvapudi 
Designation  Post Graduate 
Affiliation  JSS Medical College and hospital 
Address  Dr. Devaki Kalvapudi, Dept. of Anaesthesiology, JSS Hospital, MG Road, Mysuru

Mysore
KARNATAKA
570004
India 
Phone  9553094864  
Fax    
Email  devakikal8@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Archana K N  
Designation  Professor  
Affiliation  JSS Medical College and hospital 
Address  Department of Anaesthesiology, JSS Hospital, MG Road, Mysuru

Mysore
KARNATAKA
570004
India 
Phone  9845140637  
Fax    
Email  archanamrnm@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Archana K N  
Designation  Professor  
Affiliation  JSS Medical College and hospital 
Address  Department of Anaesthesiology, JSS Hospital, MG Road, Mysuru

Mysore
KARNATAKA
570004
India 
Phone  9845140637  
Fax    
Email  archanamrnm@yahoo.co.in  
 
Source of Monetary or Material Support  
JSS Medical College and Hospital  
 
Primary Sponsor  
Name  JSS Medical College and Hospital Mysuru 
Address  JSS Medical College and Hospital MG Road Mysuru  
Type of Sponsor  Private 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 
Dr Devaki Kalvapudi  JSS Medical College and Hospital   Department of Anaesthesiology
Mysore
KARNATAKA 
9553094864

devakikal8@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JSS Medical College and Hospital, Mysuru   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 
Comparator Agent  ENDOTRACHEAL INTUBATION WITH POLYVINYL CHLORIDE ENDOTRACHEAL TUBE THROUGH THE INTUBATING LARYNGEAL MASK AIRWAY   ENDOTRACHEAL INTUBATION WITH POLYVINYL CHLORIDE ENDOTRACHEAL TUBE THROUGH THE INTUBATING LARYNGEAL MASK AIRWAY IN ADULT PATIENTS UNDERGOING SURGERIES UNDER GENERAL ANAESTHESIA for the duration of one surgery  
Intervention  ENDOTRACHEAL INTUBATION WITH WIRE REINFORCED TUBE THROUGH THE INTUBATING LARYNGEAL MASK AIRWAY  ENDOTRACHEAL INTUBATION WITH WIRE REINFORCED TUBE THROUGH THE INTUBATING LARYNGEAL MASK AIRWAY IN ADULT PATIENTS UNDERGOING SURGERIES UNDER GENERAL ANAESTHESIA for the duration of one surgery  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patients who give informed consent
2. ASA Physical Class I/II
3. Mallampati grade I and II
4. Interdental distance of greater than 2 cm  
 
ExclusionCriteria 
Details  1. Patients who do not give consent.
2. Patients with removable dentures or very loose teeth.
3. Patients with hypertrophied tonsils (grade 3 and 4), or thyromegaly.
4. Patients who have morbid obesity.
5. Patients with a history of previous upper GI surgery 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Intubation of the endotracheal tube through the intubating laryngeal mask airway which is confirmed by bilateral air entry in the lungs and appearance of square wave capnography.   Induction of general anaesthesia until 24 hours in the post operative period.  
 
Secondary Outcome  
Outcome  TimePoints 
extreme hemodynamic fluctuations for the first 15 minutes, and post operative hoarseness of voice and sore throat for 24 hours   Induction of general anaesthesia until 24 hours in the post operative period.  
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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   N/A 
Date of First Enrollment (India)   10/11/2021 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

With approval from the Institutional Ethical Committee, informed and written consent will be taken from 60 patients of adult American Society of Anaesthesiologists (ASA) Physical Status of I/II of either sex, scheduled for elective surgery requiring general anesthesia. 

A thorough pre-anaesthetic evaluation will be performed 24 hours prior to the scheduled procedure. Patients will be kept in an NPO status overnight, allowing only for sips of water for taking Tablet Alprazolam 0.5 mg and Tablet Ranitidine 150 mg the night before the surgery. 


In the operating room, an intravenous infusion will be started, and patients will be randomly allocated to one of the two groups – Group I – intubation with cuffed PVC ETT, Group II – intubation with the flexo-metallic tube. Standard monitors will be applied – baseline parameters will be recorded including heart rate, arterial oxygen saturation, and non-invasive blood pressure recording. Patients are pre-medicated, and pre-oxygenated for 3 minutes with 100% oxygen. Anaesthesia will be induced with Inj. Fentanyl 1.5 mcg/kg and Inj. Propofol 2 mg/kg. Muscle Relaxant Inj. Vecuronium 0.1 mg/kg will be given. After complete relaxation, with the head in neutral position, an appropriate sized ILMA will be inserted. Several maneuvers and adjustments to ensure optimal positioning of the ILMA such as extension of the ILMA handle up/down movement, optimization maneuver, head-neck maneuver, rotation in the sagittal plane, or lifting away from the posterior pharyngeal wall (Chandy maneuver) will be made. A well lubricated cuffed PVC tube or flexo-metallic tube will be passed through the ILMA uptil 16 cm (the epiglottis elevating bar). The tube will be advanced into the trachea, and confirmation will be based on square-wave capnography, and prescence of bilateral breath sounds. The ILMA will then be deflated and removed using the stabilizing rod to maintain the tube in place. The ETT tube cuff will be inflated, and patient will be connected to closed circuit. The time taken for intubation is defined as the time from disconnection of the breathing circuit from the ILMA up to successful tracheal intubation. 

Optimization maneuvers will be done if initial tracheal tube passage is unsuccessful. A maximum of 3 attempts will be allowed; in case of failure, airway will be secured with direct laryngoscopy alternatively. All ILMA placement attempts and tracheal intubations will be performed by the same anaesthesiologist. After intubation, anaesthesia will be maintained with Isoflurane 0.6-1%, and 66% Nitrous oxide with closed circuit and controlled ventilation. 

After endotracheal intubation, and confirmation of correct placement with auscultation and square-wave capnograph, heart rate, arterial oxygen saturation, non invasive blood pressure and end tidal CO2 will be monitored at 1 minute intervals for the first 5 minutes following successful tracheal intubation. Thereafter, these parameters will be recorded every 5 minutes for 15 minutes after successful intubation. After extubation, all patients were evaluated for sore throat and hoarseness of voice during the first 24 hours at 1, 2, 4, 12 and 24 hours post extubation.


 
Close