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CTRI Number  CTRI/2026/02/102690 [Registered on: 02/02/2026] Trial Registered Prospectively
Last Modified On: 30/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A study to determine the accuracy of modified mallampati test grading with and without phonation for predicting difficult laryngoscopy and intubation 
Scientific Title of Study   Diagnostic accuracy of Modified Mallampati Test grading with and without phonation for predicting Difficult laryngoscopy and intubation in Adult Surgical Patients-A cross sectional 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 Somya Shekhar 
Designation  Junior Resident 
Affiliation  NKP Salve Institute of medical Sciences 
Address  Department of anaesthesiology, N K P Salve Institute Of Medical Sciences and Research Centre And Lata Mangeshkar Hospital Digdoh Hingna Road

Nagpur
MAHARASHTRA
440019
India 
Phone  9960296302  
Fax    
Email  somyashekhar3136@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Anjali Bhure 
Designation  Professor and HOD 
Affiliation  NKP Salve Institute of medical Sciences 
Address  Department of Anaesthesiology, N K P Salve Institute Of Medical Sciences and Research Centre And Lata Mangeshkar Hospital Digdoh Hingna Road

Nagpur
MAHARASHTRA
440019
India 
Phone  9822663121  
Fax    
Email  anjali_bhure@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Somya Shekhar 
Designation  Junior Resident 
Affiliation  NKP Salve Institute of medical Sciences 
Address  Department of Anaesthesiology, N K P Salve Institute Of Medical Sciences and Research Centre And Lata Mangeshkar Hospital Digdoh Hingna Road

Nagpur
MAHARASHTRA
440019
India 
Phone  9960296302  
Fax    
Email  somyashekhar3136@gmail.com  
 
Source of Monetary or Material Support  
N K P Salve Institute of Medical sciences and research centre and lata mangeshkar hospital, Digdoh hills, Hingna road, Nagpur, Maharashtra, India 440019  
 
Primary Sponsor  
Name  NKP Salve Institute of medical Sciences 
Address  NKP Salve Institute of medical Sciences and research centre and lata mangeshkar hospital, Digdoh Hills , Hingna road, Nagpur 440019 
Type of Sponsor  Private medical college 
 
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 Somya Shekhar  N K P Salve Institute Of Medical Sciences and Research Centre And Lata Mangeshkar Hospital  4t floor, Department of anaesthesiology, N K P Salve Institute Of Medical Sciences and Research Centre And Lata Mangeshkar Hospital Digdoh Hingna Road Nagpur Maharashtra INDIA
Nagpur
MAHARASHTRA 
9960296302

somyashekhar3136@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics commitee NKP Salve Inst  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 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1)Adult patients aged above 18 years
2)ASA physical status I , II and III Scheduled for elective surgery under general anaesthesia requiring endotracheal intubation.
3)Patients providing informed written consent.


 
 
ExclusionCriteria 
Details  1)Patients with maxillofacial abnormalities or restricted mouth opening (less than 3 cm);Known airway pathology (tumours, trauma, etc.).
2)Edentulous patients
3)Patients with limited neck mobility.
4)Patients with infection like submandibular and peri tonsillar abscesses.
5)Airway burn injuries or trauma.
6)Congenital abnormalities.

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To find out the diagnostic accuracy of the Modified Mallampati Test (MMT) performed with and without phonation for predicting difficult laryngoscopy and intubation with Cormack Lehane grading in adult surgical patients with respect to
Sensitivity
Specificity
Positive predictive value (PPV)
Negative predictive value (NPV)
Accuracy
Kappa
 
Modified Mallampati Test will be performed preoperatively and Cormack Lehane Score will be assessed at the time of Laryngoscopy 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="162"
Sample Size from India="162" 
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)   20/02/2026 
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="6"
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  

The American Society of anaesthesiologists (ASA) has continually emphasized the significance of preoperative airway examination and developing appropriate procedures and equipment for managing potentially difficult airways .

Difficult Airway is the clinical scenario where an anaesthesiologist with traditional training has trouble with mask ventilation, tracheal intubation, or both with one or more recognized techniques.

Inability to maintain a patent airway, Oxygenation and ventilation can quickly result in hypoxemia, brain injury, or death, especially in patients with low oxygen reserves, such as the obese, peadiatric, or critically unwell patients . Hence, early detection of a potentially problematic airway is critical to ensure patient safety.

Poorly managed Unanticipated difficult airway is a major source of morbidity and mortality.  The Fourth National Audit Project  in the United Kingdom discovered that inadequate preoperative airway assessment was a major factor in airway-related complications, many of which resulted in hypoxic brain injury or death . So improved prediction algorithms could greatly minimise this burden.

The Modified mallampati Test (MMT) is a popular bedside tool for difficult airway assessment since it is simple to perform, non-invasive, and inexpensive 

Despite its broad use, Modified mallampati predictive value has remained variable.  Several factors influence its accuracy, including the patient’s participation, tongue protrusion, position of the patient and phonation. However, no standardized approach exists, and the effect of these variances on predicting accuracy has not been well investigated .

Samsoon and Young updated the original Mallampati test from three to four classes .Modified mallampati Test is often conducted in sitting with head in neutral position and instructing the patient to open their mouth and protrude their tongue without phonation.

When phonated ("say ah"), it improves the mallampati score as it flattens the tongue , contracts the levator veli palatine muscle and pulls the soft palate upward and backwards. This anatomical relationship explains the correlation and laryngoscopic view on phonation . Hence here phonation is added as a parameter in the test to know its efficacy on mallampati examination.

The American Society of anaesthesiologists (ASA) has continually emphasized the significance of preoperative airway examination and developing appropriate procedures and equipment for managing potentially difficult airways .

Difficult Airway is the clinical scenario where an anaesthesiologist with traditional training has trouble with mask ventilation, tracheal intubation, or both with one or more recognized techniques.

Inability to maintain a patent airway, Oxygenation and ventilation can quickly result in hypoxemia, brain injury, or death, especially in patients with low oxygen reserves, such as the obese, peadiatric, or critically unwell patients . Hence, early detection of a potentially problematic airway is critical to ensure patient safety.

Poorly managed Unanticipated difficult airway is a major source of morbidity and mortality.  The Fourth National Audit Project (NAP4) in the United Kingdom discovered that inadequate preoperative airway assessment was a major factor in airway-related complications, many of which resulted in hypoxic brain injury or death . So improved prediction algorithms could greatly minimise this burden.

The Modified mallampati Test (MMT) is a popular bedside tool for difficult airway assessment since it is simple to perform, non-invasive, and inexpensive 

Despite its broad use, Modified mallampati predictive value has remained variable.  Several factors influence its accuracy, including the patient’s participation, tongue protrusion, position of the patient and phonation. However, no standardized approach exists, and the effect of these variances on predicting accuracy has not been well investigated .

Samsoon and Young updated the original Mallampati test from three to four classes .Modified mallampati Test is often conducted in sitting with head in neutral position and instructing the patient to open their mouth and protrude their tongue without phonation.

When phonated ("say ah"), it improves the mallampati score as it flattens the tongue , contracts the levator veli palatine muscle and pulls the soft palate upward and backwards. This anatomical relationship explains the correlation and laryngoscopic view on phonation . Hence here phonation is added as a parameter in the test to know its efficacy on mallampati examination.

The Cormack- Lehane (CL) grading and Mallampati classification are two widely used methods for evaluating airways and predicting difficult intubations. However, they have different functions and are carried out at various times that is one is a preoperative test while other is an intraoperative observation after induction. However their correlation is

CL Grade I–II (easy intubation) frequently correlates with Mallampati I–II.
CL Grade III–IV (difficult intubation) is more often correlated with Mallampati III–IV

This study aims to find the diagnostic accuracy of Modified mallampati Test with and without phonation in upright position with Cormack- Lehane Grade III/IV  in predicting difficult laryngoscopy and intubation in adult surgical patients.

As there is limited data available in the literature regarding  the effect of phonation on modified mallampati test, the outcome of our study may lead to standardizing the way mallampati test is performed.


 
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