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CTRI Number  CTRI/2023/06/054281 [Registered on: 21/06/2023] Trial Registered Prospectively
Last Modified On: 12/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Comparison between Mallampati Classification & Friedmans Tongue Positions for assessment before anaesthesia 
Scientific Title of Study   A prospective comparison between Mallampati Classification & Friedmans Tongue Positions for airway assessment and their correlation with Cormac-Lehane grading. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NA  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sohan Lal Solanki 
Designation  Professor 
Affiliation  Tata Memorial Hospital, Mumbai 
Address  Room No 210, Second Floor, OT Complex, Main Building, Tata Memorial Hospital, Dr E Borges Marg, Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9869253201  
Fax    
Email  sohan.solanki@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vaibhavi Desikan 
Designation  Junior Resident 
Affiliation  Tata Memorial Hospital,Mumbao 
Address  Room No 210, Second Floor, OT Complex, Main Building, Tata Memorial Hospital, Dr E Borges Marg, Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9677812093  
Fax    
Email  vaibhavigopal.96@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vaibhavi Desikan 
Designation  Junior Resident 
Affiliation  Tata Memorial Hospital,Mumbao 
Address  Room No 210, Second Floor, OT Complex, Main Building, Tata Memorial Hospital, Dr E Borges Marg, Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9677812093  
Fax    
Email  vaibhavigopal.96@gmail.com  
 
Source of Monetary or Material Support  
Tata Memorial Hospital, Mumbai 
 
Primary Sponsor  
Name  Dr Sohan Lal Solanki 
Address  Room No 210, Second Floor, OT Complex, Main Building, Tata Memorial Hospital, Dr E Borges Marg, Parel, Mumbai  
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NA  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sohan Lal Solanki  Tata Memorial Hosptal  Room No 210, Second Floor, OT Complex, Main Building, Tata Memorial Hospital, Dr E Borges Marg, Parel, Mumbai
Mumbai
MAHARASHTRA 
9869253201

sohan.solanki@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC-1, Tata Memorial Centre  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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Friedmans Tongue Position  The Friedmans Tongue Position will be will be done by the clinician who should ask the patient to open his/her mouth widely, a minimum of 5 times. This allows the observer to assign the most consistent position of the tongue. The patient should also be instructed to “breathe normally,” while leaving the tongue in its natural position. This test is done independently by another anaesthetist. FTP GRADING Grade 1 Visualises uvula and tonsils Grade 2a visualises most of uvula but not tonsils Grade 2b visualises entire soft palate to base of uvula Grade 3 Visualises some part of the soft palate Grade 4 Visualises only the hard palate  
Intervention  Mallampatti Grading  The Mallampatti grading will be performed to assess the oropharyngeal view by asking the patient to sit and open his/her mouth maximally and to protrude the tongue without phonation and record the structures visible upon maximal mouth opening and classified as score. Class 1: Faucial pillars , soft palate and uvula are visualised Class 2: Faucial pillars and soft palate visualised but uvula masked by tongue base Class 3: Soft palate visualised Class 4: Soft palate not visualised  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Adult patients posted for oncological procedures
Requiring laryngoscopy and tracheal intubation
Mouth Opening of at least 3 cm.
ASA I-III
 
 
ExclusionCriteria 
Details  Tongue Cancer
Ankyloglossia
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Cormac-Lehane Grading during tracheal Intubation  At the time of tracheal intubation 
 
Secondary Outcome  
Outcome  TimePoints 
Inter-observer correlation between Mallampatti Classification evaluation
and Friedman’s Tongue Position evaluation
 
During airway assessment.  
Cormac-Lehane Grading during tracheal Intubation in Oral Cancer Patients  At the time of tracheal intubation  
Correlation of higher Mallampatti Classification & higher Friedman’s Tongue Position with requirement of video laryngoscope
 
At the time of tracheal intubation 
Inter-observer variability of Cormac-Lehane Grading between 1st & 2nd (senior) operator during direct laryngoscopy  At the time of tracheal intubation 
 
Target Sample Size   Total Sample Size="214"
Sample Size from India="214" 
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)   03/07/2023 
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="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
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  

Difficulty in airway management is an important cause of morbidity and mortality in anesthetic practice. Unanticipated difficult intubation can be challenging to anesthesiologists, and numerous investigators have attempted to predict difficult intubation by using various bedside tests.

The Modified Mallampati Class (MPC) score, thyromental distance (TMD), sternomental (SM) distance, inter incisor gap, BMI, and ability to flex and extend the cervical spine, neck circumference, upper lip bite test, are some of the widely recognized as tools for predicting difficult intubation.

 

The Mallampati grade was first developed by Seshagiri Mallamapati in 1985. He was an anesthesiologist who sought to predict the risk of difficult intubation based on mouth opening. Using a simple three-grade classification based on whether Mallampatti grade could visualize the tonsillar pillars, uvula, and soft palate, he showed correlation between Mallampatti grade and view of the airway on direct laryngoscopy. Samsoon and Young reported a modification of the Mallampati grade when even the soft palate was difficult to visualize and they added an additional classification, grade 4, where only the hard palate was able to be visualized. This modification is called Modified Mallampatti Class (MPC) grade.

 

The Friedman Tongue Position (FTP) was introduced and used as a tool by pulmonologists to predict the severity of Obstructive Sleep Apnoea (OSA). FTP is the evaluation of the tongue’s position relative to the tonsils/pillars, uvula, soft palate, and hard palate. It is a test known to predict difficult airway in OSA patients.

While the Mallampati system has 3 grades and evaluates the palate with the tongue protruded, FTP evaluates the palate with the tongue in a neutral position inside the mouth. Furthermore, FTP is assigned on a scale from I to IV, and FTP II is split into IIa and IIb. FTP I allows the observer to visualize the entire uvula and tonsils or pillars. FTP IIa allows visualization of the uvula but the tonsils are only partially seen. FTP IIb allows visualization of the complete soft palate down to the base of the uvula, but the uvula and the tonsils are not seen. FTP III allows visualization of some of the soft palate but the distal soft palate is eclipsed. FTP IV allows visualization of the hard palate only.

 

The MPC is a test that is used universally by anaesthesiologists to screen any airway for predicting difficulty in intubation. During intubation, the tongue remains inside the oral cavity, as opposed to the condition simulated during the MPC. As a result, it may not be the most accurate measure of predicting difficult airway. Our study hypotheses that since the FTP allows us to evaluate the oral cavity in the condition that mimics the situation during intubation, it would be just as good as the MPC in predicting the difficult airway. 

 
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