FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/03/051104 [Registered on: 28/03/2023] Trial Registered Prospectively
Last Modified On: 27/03/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Single Arm Study 
Public Title of Study   To evaluate and compare ultrasound indices with Cormack-Lehane grading for predicting difficult airway 
Scientific Title of Study   Evaluation and comparison of ultrasound indices with Cormack-Lehane grading for predicting difficult airway 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Haramritpal Kaur 
Designation  Associate Professor  
Affiliation  GGS medical college and Hospital  
Address  Dept. Of Anaesthesiology,GURU GOBIND SINGH MEDICAL COLLEGE AND HOSPITAL,DEPT. OF ANESTHESIOLOGY FARIDKOT
Faridkot -151203
Faridkot
PUNJAB
151203
India 
Phone  9878088013  
Fax    
Email  amritk_dr@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Haramritpal Kaur 
Designation  Associate Professor  
Affiliation  GGS medical college and Hospital  
Address  Dept of Anaesthesiology,GURU GOBIND SINGH MEDICAL COLLEGE AND HOSPITAL,DEPT. OF ANESTHESIOLOGY FARIDKOT
Faridkot,Punjab
Faridkot
PUNJAB
151203
India 
Phone  9878088013  
Fax    
Email  amritk_dr@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Prachi Sharma  
Designation  Junior Resident 
Affiliation  GGS medical college and Hospital  
Address  Dept. Of Anaesthesiology,GGS MEDICAL COLLEGE AND HOSPITAL ,FARIDKOT
Faridkot Punjab
Faridkot
PUNJAB
151203
India 
Phone  9861458501  
Fax    
Email  prachi4sharma.1@gmail.com  
 
Source of Monetary or Material Support  
Dept. Of Anaesthesiology,GGS medical college and Hospital Faridkot-151203,Punjab  
 
Primary Sponsor  
Name  Dr Haramritpal Kaur 
Address  Dept. Of Anaesthesiology,GGS MEDICAL COLLEGE AND HOSPITAL ,FARIDKOT  
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Dr Sarvjeet Kaur   GGSMCH Faridkot 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
PRACHI SHARMA   GGS medical college and Hospital   Dept. Of Anaesthesiology,GGS MEDICAL COLLEGE AND HOSPITAL FARIDKOT
Faridkot
PUNJAB 		 9861458501

prachi4sharma.1@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B||Imaging,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Clinical difficult airway indices   Direct laryngoscopy and CL Grade evaluation  
Intervention  ultrasound  In the pre- operating holding area with the patient lying supine and in sniffing position,the sonographic assessment will be done with the high frequency (7.5Mhz)linear probe, placed in the submandibular area in the midline for 15 minutes. 
Intervention  Ultrasound usage   Airway ultrasound will be done  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1)Patients undergoing elective surgery under general anaesthesia
2) ASA grade I and II
3)Patients age between 18 to 65 years giving valid informed and written consent.

 
 
ExclusionCriteria 
Details  1) Obese patients with BMI more than 25 kg per metre square
2) Pregnant women
3) Cervical- spine abnormalities
4) Fibre optic tracheal intubation
5) Rapid sequence induction conditions

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   On-site computer system 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1.TO evluate ultrasound indices for prediction of difficult airway
2. to evaluate difficult airway with Cormack-Lehane Grading
3.To correlate the ultrasound Indices with Cormack Lehane Grading for difficult airway assessment  		 Outcome will be assessed at the end of study that is 12months
 
 
Secondary Outcome  
Outcome  TimePoints 
NA  NA 
 
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)   01/04/2023 
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   None 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [prachi4sharma.1@gmail.com].

  6. For how long will this data be available start date provided 10-02-2024 and end date provided 10-02-2029?
    Response (Others) -  5 years till study is completed

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary  

INTRODUCTION: Airway related morbidity due to inability to anticipate difficult airway is one of  the primary concern for anaesthesiologist during airway management.. The inability to predict difficult airway is probably due to low predictability of commonly used airway assessment screening tests . Airway sonography is a non-invasive,safe,and painless modality that can be used as a  diagnostic device for measurement of dimension that may be linked to the prediction of difficult airway .

AIMS AND OBJECTIVES : To evaluate the ultrasound Indices for prediction of difficult airway and correlate it with Cormack -Lehane grading for difficult airway assessment. 

 
Close