| CTRI Number |
CTRI/2025/11/096863 [Registered on: 03/11/2025] Trial Registered Prospectively |
| Last Modified On: |
02/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
This study comparing mallampati test for inner mouth condition in sitting and lying down positions to find out which position better predicts difficult tube insertion during anesthesia |
|
Scientific Title of Study
|
A comparative study to predict difficult intubation by using modified mallampati grading in sitting position versus supine position in SMS medical college jaipur |
| 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 Rajeev Shrma |
| Designation |
Senior Professor |
| Affiliation |
Department of anesthesia, SMS medical college and attached hospital Jaipur |
| Address |
Department of anesthesia,
SMS medical college and attached hospital
Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9829088926 |
| Fax |
|
| Email |
sharma.rajeev0911@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajeev Shrma |
| Designation |
Senior Professor |
| Affiliation |
Department of anesthesia, SMS medical college and attached hospital Jaipur |
| Address |
Department of anesthesia,
SMS medical college and attached hospital
Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9829088926 |
| Fax |
|
| Email |
sharma.rajeev0911@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shriniwas Meena |
| Designation |
Resident doctor |
| Affiliation |
Department of anesthesia, SMS medical college & attached hospital Jaipur |
| Address |
Department of anesthesia,
SMS medical college and attached hospital
Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
8107071537 |
| Fax |
|
| Email |
shriniwasmeena18@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anesthesia, SMS medical college and attached hospital Jaipur,rajasthan, india-302004 |
|
|
Primary Sponsor
|
| Name |
Department of anesthesia SMS medical college and attached hospital Jaipur |
| Address |
Department of anesthesia,
SMS medical college and attached hospital
jaipur
rajasthan
India 302004 |
| Type of Sponsor |
Government medical college |
|
|
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 Rajeev Sharma |
SMS medical college and attached hospital Jaipur |
Department of anesthesia,2nd floor dhanawantri building
Jaipur
RAJASTHAN |
9829088926
sharma.rajeev0911@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of ethics comittee sms medical college jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient undergoing intubation
patient giving written and informed concent
able to comply with test |
|
| ExclusionCriteria |
| Details |
emergency case
recent oral or maxillofacial surgery
restricted neck movement
patient unable to rit
upper airway pathology like mass in oral cavity |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Mean of MODIFIED MALLAMPATI TEST
Mean of CORMAC LEHANE GRADE |
after complition of study
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
sensitivity
specificity
positive predictive value
negative predictive vslue |
after case complete |
|
|
Target Sample Size
|
Total Sample Size="125"
Sample Size from India="125"
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)
|
17/11/2025 |
| 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="0"
Months="3"
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 Mallampati classification is normally evaluated in the sitting
position. However, many patients cannot be evaluated in the sitting position
for medical reasons. Thus, we compare the mallampati test in sitting and supine
positions in predicting difficult tracheal intubation (DTI). We hypothesize
that the diagnostic accuracy of the mallampati test perform in sitting and
supine positions would differ It has been suggested that the size of the base
of the tongue is an important factor
determining the degree of difficulty of direct laryngoscopy. A relatively
simple grading system which involves preoperative ability to visualize the
faucial pillars, soft palate and base of uvula was designed as a means of
predicting the degree of difficulty in laryngeal exposure. Procedure- after evaluating preoperatively,
informed and written consent will be taken. Airway examination will be
performed by an experienced anaesthesiologist in all cases. The modified
Mallampatti score will be measured in a sitting position with the patient’s
mouth wide open and protruding tongue without saying "Ah" By
observer. Before induction time the same observer demonstrates the modified
Mallampati test in supine positionwhile the patient turned to supine
in operation theater table. Mallampati classes I and II will considered as easy
or low risk and classes III and IV will be considered as difficult or high
risk. The anesthetist classifie the laryngoscopy view (Cormack and Lehan’s
grade) at the time of induction and intubation using a Macintosh blade 3 or 4.
Difficult laryngoscopy will defined as Grade III or IV, whereas an easy
laryngoscopy will defined as Grade I or II. |