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CTRI Number  CTRI/2024/10/076048 [Registered on: 29/10/2024] Trial Registered Prospectively
Last Modified On: 28/10/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Paving the way for the future of airway management by ultrasound guided endotracheal tube placement 
Scientific Title of Study   Real time dynamic ultrasound guided endotracheal intubation: A future foreseen 
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 Kartik Syal  
Designation  Associate professor,Department of anaesthesia IGMC Shimla 
Affiliation  ASSOCIATE PROFESSOR IGMC SHIMLA 
Address  Dr Kartik Syal OT complex department of anaesthesia IGMC Shimla

Shimla
HIMACHAL PRADESH
171001
India 
Phone  9418485155  
Fax    
Email  kartik.syal@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Kartik Syal  
Designation  Associate professor,Department of anaesthesia IGMC Shimla 
Affiliation  ASSOCIATE PROFESSOR IGMC SHIMLA 
Address  Dr Kartik Syal OT complex department of anaesthesia IGMC Shimla

Shimla
HIMACHAL PRADESH
171001
India 
Phone  9418485155  
Fax    
Email  kartik.syal@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Kartik Syal  
Designation  Associate professor,Department of anaesthesia IGMC Shimla 
Affiliation  ASSOCIATE PROFESSOR IGMC SHIMLA 
Address  Dr Kartik Syal OT complex department of anaesthesia IGMC Shimla

Shimla
HIMACHAL PRADESH
171001
India 
Phone  9418485155  
Fax    
Email  kartik.syal@gmail.com  
 
Source of Monetary or Material Support  
Indira Gandhi Medical College Shimla(H.P.) 
 
Primary Sponsor  
Name  Indira Gandhi Medical college Shimla HP 
Address  Department of anaesthesia IGMC Shimla, Lakkar Bazar Shimla H.P.(171001) 
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 
Dr ABHINAV MAKKAR  IGMC SHIMLA  OT complex(1,2,3,4) department of anaesthesia
Shimla
HIMACHAL PRADESH 		 9816285886

abhinavmakkar1996@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC Dr Radhakrishnan Government Medical College Hamirpur Himachal Pradesh   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  Endotracheal intubation  A method of securing airway in patients undergoing general anaesthesia The total duration of this intervention is less than one minute The total duration of study of cases of this intervention will be one month 
Comparator Agent  Lightwand endotracheal intubation  Comparative study of ultrasound guided endotracheal intubation versus light wand intubation in patients undergoing laparoscopic cholecystectomy 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Inclusion criteria included a body mass index (BMI) of 18.5–25 kg·m− 2, American Society of Anesthesiologists (ASA) physical status I-II, and Mallampati Grade I-II.  
 
ExclusionCriteria 
Details  Exclusion criteria included any sign of difficult airway such as mouth and neck mass or infection, allergy to the study drugs, drug or alcohol abuse, and pregnancy.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
The primary outcome was to compare the success rate of intubation of the two groups on the first attempt.  The outcome is the success is taken as confirmation of waveform on wave capnography immediately.No outcome is measured later on after 1 or 2 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
the secondary outcomes were to detect the overall success rate, time of intubation,hemodynamic response to intubation in both groups and complications related to tracheal intubation including events of desaturation hoarseness and sore throat were also recorded  time was taken from tube passing through upper lip till confirmation by wave capnography 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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 
Date of First Enrollment (India)   10/11/2024 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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   UGTI is feasible option for intubation without conventional laryngoscopy.This study defines the probable methodology to be used while performing ultrasound guided intubation.This can prove to be minimally invasive, real time infallible and full proof technique for endotracheal intubation.Laryngoscopy is the basic skill of any anaesthesiologist but this approach cannot be used universally especially in syndromic cases and acquired conditions like ankylosing spondylitis ,rheumatoid arthritis and airway trauma along with many others.It is like using typewriters in the era of word processors.Though there are many established tools for endotracheal intubation most common being video laryngoscope followed by flexible fiberoptic bronchoscope but our modality offers a standard equipment in use that is ultrasonography available in maximum centres with more clinical exposure and proposes similar effectiveness to established light wand intubation with minimal hemodynamic pertubations. 
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