FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2020/08/027487 [Registered on: 31/08/2020] Trial Registered Prospectively
Last Modified On: 21/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   how to know the difficulty of putting a tube in your throat during operation by using ultrasound  
Scientific Title of Study   Evaluation of airway ultrasound parameters in predicting difficult airway: A Prospective observational study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
IEC/AIIMS BBSR/PG THESIS/2020-21/42  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Aparajita panda 
Designation  Associate professor,Department of Anaesthesiology 
Affiliation  All India Institute of Medical Sciences, Bhubaneswar 
Address  Academic block, All India Institute of Medical Sciences, Sijua, Patrapada, Bhubaneswar

Khordha
ORISSA
751019
India 
Phone  9438884118  
Fax    
Email  anaes_aparajita@aiimsbhubaneswar.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Aparajita panda 
Designation  Associate professor,Department of Anaesthesiology 
Affiliation  All India Institute of Medical Sciences, Bhubaneswar 
Address  Academic block, All India Institute of Medical Sciences, Sijua, Patrapada, Bhubaneswar


ORISSA
751019
India 
Phone  9438884118  
Fax    
Email  anaes_aparajita@aiimsbhubaneswar.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr Sambit Nandi 
Designation  Junior Resident, Academic,Department of Anaesthesiology 
Affiliation  All India Institute of Medical Sciences, Bhubaneswar 
Address  PG-3 hostel, Aiims residential campus, All India Institute of Medical Sciences, Sijua, Patrapada, Bhubaneswar

Khordha
ORISSA
751019
India 
Phone  7809425800  
Fax    
Email  nandi.sambit@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Bhubaneswar 
 
Primary Sponsor  
Name  Dr Aparajita Panda 
Address  Academic Block, All India Institute of Medical Sciences, Sijua, Patrapada, Bhubaneswar, PIN 751019 
Type of Sponsor  Other [Self] 
 
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 Aparajita Panda  Department of Anaesthesiology, All India Institute of Medical Sciences, Bhubaneswar  Sijua, Patrapada, Bhubaneswar, PIN 751019
Khordha
ORISSA 
9438884118

anaes_aparajita@aiimsbhubaneswar.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, AIIMS, Bhubaneswar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 4||Measurement and Monitoring, (2) ICD-10 Condition: B||Imaging,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Age 18-65 years who require tracheal intubation for elective surgery under general anaesthesia
2.ASA grade 1,2 and 3
 
 
ExclusionCriteria 
Details  1.Refusal to consent
2.Patients planned for fiberoptic intubation
3.Patients in whom USG neck is not feasible
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Co-relation between the sonographic measurements of anterior cervical soft tissue thickness, tongue height to oral height ratio and Cormack-Lehane grade at direct laryngoscopy view in patients  Preoperatively and intraoperatively 
 
Secondary Outcome  
Outcome  TimePoints 
1.To determine a cut off value for the above measurements
2.To determine the ease of obtaining USG parameters
 
preoperatively and intraoperatively 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/09/2020 
Date of Study Completion (India) 30/09/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 30/09/2022 
Estimated Duration of Trial   Years="1"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
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
Modification(s)  

Airway assessment plays a key role during pre-anaesthetic assessment. Identifying difficult airway beforehand can help us in adequate preparation, selection of  equipments , and participation of skilled persons during intubation. Airway assessment is usually done using different clinical parameters such as Body Mass Index (BMI), circumference of neck , Mallampati score, interincisior gap, sternomental distance, thyromental distance and neck mobility. These parameters are often used in combination so as to overcome their low sensitivity in predicting difficult airway. Incidence of unanticipated difficult airway stands at 1%-8% in spite of using multiple screening tools. Moreover, in case of unconscious and uncooperative patients, clinical tools have limited use. To overcome the above limitations of clinical airway assessment tools, there is a need to develop an accurate airway assessment tool.

 

Ultrasonography, being simple, portable, bed-side, non-invasive and non-ionizing tool, has been proposed recently as an aid for airway assessment and predicting difficult laryngoscopy. Various ultrasonographic measurements i.e. distance between skin and hyoid bone, distance from skin to thyrohyoid membrane, skin to epiglottis distance , distance from skin to vocal cord have been used for this purpose.

 

To the best of our knowledge the data from previous studies are inconclusive, also the data from Indian population is not so robust. Therefore, we are planning to conduct the current study while including a novel ultrasonographic parameter i.e. tongue thickness to oral height ratio in assessing difficult airway.

 
Close