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
|
|
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
|
|
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. |