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CTRI Number  CTRI/2023/06/054146 [Registered on: 20/06/2023] Trial Registered Prospectively
Last Modified On: 16/06/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective 
Study Design  Single Arm Study 
Public Title of Study   Using ultrasound to compare the thickness of tongue and the distance between hyoid bone and chin to predict weather intubation will be difficult or not 
Scientific Title of Study   Comparison of Ultrasonographic measurement of tongue volume hyomental distance for prediction of difficult intubation 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Abhay Sancheti 
Designation  Associate Professor 
Affiliation  Department of Anaesthesia  
Address  Bharati Hospital, Satara Road, Dhankawadi, Pune, Maharashtra

Pune
MAHARASHTRA
411043
India 
Phone  9371107686  
Fax    
Email  abhi6264@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Abhay Sancheti  
Designation  Associate Professor 
Affiliation  Bharati Hospital, Department of Anaesthesia 
Address  B702 The Legend, Lake town road, Bibwewadi, Pune

Pune
MAHARASHTRA
411037
India 
Phone  9371107686  
Fax    
Email  abhi6264@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Nudhair Ahmed 
Designation  Junior Resident 
Affiliation  Department of Anaesthesia, Bharati Hospital 
Address  Bharati Hospital, Satara Road, Dhankawadi, Pune, Maharashtra

Pune
MAHARASHTRA
411043
India 
Phone  8333036347  
Fax    
Email  drnudhairahmed@gmail.com  
 
Source of Monetary or Material Support  
Bharati Hospital, Dhankawadi, pune, Maharashtra, 411043 
 
Primary Sponsor  
Name  Bharati hospital and Research centre  
Address  Bharati Hospital and Research Centre Dhankawadi, Pune, Maharashtra 411043 
Type of Sponsor  Research institution and hospital 
 
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 Abhay Sancheti  Bharati Hospital  Department of Anaesthesia, Major OT complex, 3rd Floor, Pre-operative room
Pune
MAHARASHTRA 		 9371107686

abhi6264@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Bharati Vidyapeeth Medical College Institutional 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 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Age group: Above 18y posted for elective surgery under GA with endotracheal intubation. 2. ASA I/ II/ III 
 
ExclusionCriteria 
Details  1. Submandibular or neck swellings 2. Anticipated Difficult airway 3. Facial deformity 4. cervical spine injury 5. operated cases of head and neck surgeries 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To collect the data and establish the standard value for tongue volume and hyomental distance for prediction of difficult intubation  By th end of study 
 
Secondary Outcome  
Outcome  TimePoints 
To collect the data and establish the standard value for tongue volume and hyomental distance for prediction of difficult intubation  By the end of study 
 
Target Sample Size   Total Sample Size="97"
Sample Size from India="97" 
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)   01/07/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/07/2023 
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   Nil 
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

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

  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 [abhi6264@gmail.com].

  6. For how long will this data be available start date provided 14-01-2023 and end date provided 14-01-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
 Airway assessment is an essential component for anaesthesiologist. Securing an airway could be challenging at times even in expert hands.
The airway structure, shape, and its movement is generally assessed clinically preoperatively through various methods such as mouth opening, Modified Mallampati classification, upper lip bite test, thyromental distance, and sternomental distance. Under laryngoscopy, the visualisation of cords is important to perform a smooth intubation. Cormack- Lehane grading is used to assess the visualization of cords1
Inadequate ventilation, esophageal intubation, and difficult tracheal intubation2 are the most common mechanisms of respiratory-related adverse outcomes such as hypoxemia, apnea and even arrest.
Due to these reasons, we need to find a highly sensitive and specific method of assessing airway as an adjuvant to the routine clinical methods so that we could predict a difficult airway and be prepared for it. Ultrasound imaging3 is a very reliable tool in these circumstances. Modern ultrasound machines are more compact and portable with better resolution and enhanced tissue penetration. The major advantage of ultrasound is that it can be used noninvasively in the Pre-op room.
Some patients have unusually large tongue volume and sometimes the soft tissue in the anterior neck region is more than usual, this makes the airway passage narrow and hence visualization of vocal cords difficult. Through ultrasonography we can measure the tongue volume and hyomental distance
6

 preoperatively. Different parameters4 can be used ultrasonographically to assess deeper structures such as Hyomental distance and tongue volume that cannot be visualized through naked eyes.
Christina et al in 20215 studied hyomental distances in various positions of neck and suggested that Hyomental distance have superior diagnostic accuracy in predicting difficult laryngoscopy. Ruchi ohri et al in 20206 studied measurement of tongue volume ultrasonographically preoperatively and suggested that tongue volume is a good predictor of difficult laryngoscopy. Wozniac, et al in 20127 studied both the parameters hyomental distance and tongue volume and suggested that hyomental distance was a better predictor in obese patients with large neck and tongue volume. This Cross sectional study is an attempt to compare tongue volume measurement with hyomental distance to predict difficult intubation and to correlate the prediction of difficult airway by Mallampatti score and Body Mass Index with ultrasound measurement.

References

1. Cormack Lehane classification : Evidence based practice of anaesthesiology by Lee A. FleisherR. Krage, C. van Rijn, D. van Groeningen, S. A. Loer, L. A. Schwarte, P. Schober, Cormack–Lehane classification revisited, BJA: British Journal of Anaesthesia, Volume 105, Issue 2, August 2010, Pages 220–227, https://doi.org/10.1093/bja/aeq136
2. Xu Z, Ma W, Hester DL, Jiang Y. Anticipated and unanticipated difficult airway management. Curr Opin Anaesthesiol. 2018 Feb;31(1):96-103. doi: 10.1097/ACO.0000000000000540. PMID: 29176376.
3. Vishal Koundal, Shelly Rana, Ravinder Thakur, Vrinda Chauhan, Sony Ekke, and Manuj Kumar; Indian J Anaesth. 2019 Dec; 63(12): 1022–1028; doi: 10.4103/ija.IJA_492_19
4. Parameswari A, Govind M, Vakamudi M. Correlation between preoperative ultrasonographic airway assessment and laryngoscopic view in adult patients: A prospective study. J Anaesthesiol Clin Pharmacol. 2017 Jul-Sep;33(3):353-358. doi: 10.4103/joacp.JOACP_166_17. PMID: 29109635; PMCID: PMC5672513.
5. Cristina Petrișor, Anaesthesiology Intensive Therapy 2018, vol. 50, no 2, 110–116 ISSN 1642–5758 10.5603/AIT.2018.0017
6. Ohri R, Malhotra K. Different 2D ultrasound calculation methods to evaluate tongue volume for prediction of difficult laryngoscopy. Indian J Anaesth. 2020 Aug;64(Suppl 3):S193-S197. doi: 10.4103/ija.IJA_843_19. Epub 2020 Aug 15. PMID: 33162601; PMCID: PMC7641053.
7. Wojtczak, Jacek A. (2012). Submandibular Sonography. Journal of Ultrasound in Medicine, 31(4), 523–528. doi:10.7863/jum.2012.31.4.523
 
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