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CTRI Number  CTRI/2025/02/080983 [Registered on: 20/02/2025] Trial Registered Prospectively
Last Modified On: 18/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   An observational study to see whether there is change in Mallampati score with inspiration and expiration.  
Scientific Title of Study   TO EVALUATE THE CHANGE OF MALLAMPATI SCORE WITH INSPIRATION AND EXPIRATION: AN OBSERVATIONAL STUDY 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sambaturu Vedanth 
Designation  Post Graduate Trainee Student 
Affiliation  Gauhati Medical College and Hospital 
Address  Department of Anaesthesiology and Critical Care Gauhati Medical College and Hospital Bhangagarh Guwahati Kamrup Metro 781032 Assam Kamrup ASSAM 781032 India

Kamrup
ASSAM
781032
India 
Phone  9381389304  
Fax    
Email  vedanthkanna1234@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Priyam Saikia 
Designation  Associate Professor 
Affiliation  Gauhati Medical College and Hospital 
Address  Department of Anaesthesiology and Critical Care Gauhati Medical College and Hospital Bhangagarh Guwahati Kamrup Metro 781032 Assam Kamrup ASSAM 781032 India

Kamrup
ASSAM
781032
India 
Phone  9706067392  
Fax    
Email  saikia.priyam80@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sambaturu Vedanth 
Designation  Post Graduate Trainee Student 
Affiliation  Gauhati Medical College and Hospital 
Address  Department of Anaesthesiology and Critical Care Gauhati Medical College and Hospital Bhangagarh Guwahati Kamrup Metro 781032 Assam Kamrup ASSAM 781032 India

Kamrup
ASSAM
781032
India 
Phone  9381389304  
Fax    
Email  vedanthkanna1234@gmail.com  
 
Source of Monetary or Material Support  
Gauhati Medial College and Hospital, Bhangagarh, Guwahati,Kamrup(Metro)-781032  
 
Primary Sponsor  
Name  Dr Sambaturu Vedanth 
Address  Department ofAnaesthesiology and Critical Care, Gauhati Medical College and Hospital ,Bhangagarh ,Guwahati, Kamrup Metro,Assam,Pin-781032 
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 Sambaturu Vedanth  Gauhati Medical College and Hospital  Department of anaesthesiology and Critical Care, Gauhati Medical College and Hospital, Bhangagarh ,Gawahati, Kamrup(Metro)Assam,Pin-781032
Kamrup
ASSAM 		 9381389304

vedanthkanna1234@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutionl ethics Committee, Gauhati Medical College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R688||Other general symptoms and signs,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  nil  nil 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1)Age group between 18 to 65 years scheduled for elective surgery requiring general anaesthesia and endotracheal intubation
2)ASA grading 1 & 2. 
 
ExclusionCriteria 
Details  1)Pregnant women.
2)Obese patients, DM patient, Upper body burns patients.
3)Restricted mouth opening, intraoral pathology (fibrosis, tonsillitis, tumours, dental infections)
4)Patient on radiation therapy, pt with neurological disorders like tetanus, bells palsy.
Patient with cervical trauma.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the change of Mallampati score during inspiration & expiration  At inspiration for 5 seconds and expiration for 5 seconds 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the change of THYROMENTAL DISTANCE & STERNOMENTAL DISTANCE with inspiration & expiration.
 		 At inspiration for 5 seconds & expiration for 5 seconds 
 
Target Sample Size   Total Sample Size="413"
Sample Size from India="413" 
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)   02/03/2027 
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)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  

FOR MALLAMPATI SCORE:

· Keeping the patients tongue protruded ,patients will be instructed to inhale and hold their breath, and inspiration Mallampati score will be obtained.

· Then in the same view, patients will be instructed to exhale and expiration Mallampati score will be  obtained

· The documented Mallampati score with the respiration will be  compared with the baseline Mallampati score documented by the anesthesia team in pac clinic

· Scoring will be  partitioned into 7 categories[8]:

§ WORSE : [ -3,-2,-1]

§ SAME     : [ 0 ]                   

§ BETTER: [1,2,3]  

· For example: If a patients reference Mallampati score was 2, but it was 3 during inspiration , we would score that change as -1.

FOR TMD WITH RESPIRATION:

· Patient will be instructed to extend hisher neck to maximum with the mouth closed .

· And the patient will be  instructed to inhale and hold and the measurement is documented and patient will be instructed to exhale and measurement is documented.

FOR SMD WITH RESPIRATION:

Sternomental distance is measured as they’re mental distance is measured and measurement is document


REFERENCES 

1. Hanouz JL, Bonnet V, Buléon C, et al. Comparison of the Mallampati classification in sitting and supine position to predict difficult tracheal intubation: a prospective observational cohort study. Anesthesia & Analgesia . 2018;126(1):161–9.

2.  Manabe Y, Iwamoto S, Miyawaki H, Seo K, Sugiyama K. Mallampati classification without tongue protrusion can predict difficult tracheal intubation more accurately than the traditional Mallampati classification. Oral Science International . 2014;11(2):52–5.

3. Tham EJ, Gildersleve CD, Sanders LD, Mapleson WW, Vaughan RS. Effects of posture, phonation and observer on mallampati classification. British Journal of Anaesthesia . 1992;68(1):32–8.

4.  Nuckton TJ, Glidden DV, Browner WS, Claman DM. Physical examination: Mallampati score as an independent predictor of obstructive sleep apnea. Sleep . 2006;29(7):903–8.

5.   Osman AM, Carberry JC, Gandevia SC, Butler JE, Eckert D J. Changes in pharyngeal collapsibility and genioglossus reflex responses to negative pressure during the respiratory cycle in obstructive sleep apnoea. The Journal of Physiology . 2020;598(3):567–80.

6. Osman AM, Carberry JC, Gandevia S C, Butler J E, Eckert D J. Changes in pharyngeal collapsibility and genioglossus reflex responses to negative pressure during the respiratory cycle in obstructive sleep apnoea. The Journal of Physiology . 2020;598(3):567–80.

7. Lee A, Fan LTN, Gin T, Karmakar MK, Ngan Kee W D. A systematic review (Meta-Analysis) of the accuracy of the Mallampati tests to predict the difficult airway. Anesthesia and Analgesia . 2006;102(6):1867–78.

8.  Naftalovich R, Oydanich M, Adeola J, Eloy JD, Rodriguez-Correa D, Tewfik GL. A Prospective Cohort Study on the Respiratory Effect on Modified Mallampati Scoring. Anesthesiol Res Pract. 2023 Aug 23;2023:2193403

 
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