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CTRI Number  CTRI/2023/09/057635 [Registered on: 14/09/2023] Trial Registered Prospectively
Last Modified On: 13/09/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   prospective 
Study Design  Other 
Public Title of Study   Comparing the three airway tests to predict difficult intubation in diabetic patients  
Scientific Title of Study   Comparison of Airway Assessment tests to predict Difficult Laryngoscopy in Diabetic Patients - Single Blinded Prospective 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 Anjali Rana 
Designation  Junior Resident 
Affiliation  Goa Medical College 
Address  Department of Anaesthesiology, Goa Medical College, Bambolim,North Goa
Department of Anaesthesiology, Goa Medical College, Bambolim,North Goa 403202
North Goa
GOA
403202
India 
Phone  9421597560  
Fax    
Email  anjimbbs28@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shirley Ann Dsouza  
Designation  Head of Department  
Affiliation  Goa Medical College 
Address  Department of Anaesthesiology, Goa Medical College, Bambolim,North Goa
Department of Anaesthesiology, Goa Medical College, Bambolim,North Goa 403202
North Goa
GOA
403202
India 
Phone  9822159170  
Fax    
Email  shirley_dsouza05@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Anjali Rana 
Designation  Junior Resident 
Affiliation  Goa Medical College 
Address  Department of Anaesthesiology, Goa Medical College, Bambolim,North Goa
Department of Anaesthesiology, Goa Medical College, Bambolim,North Goa 403202
North Goa
GOA
403202
India 
Phone  9421597560  
Fax    
Email  anjimbbs28@gmail.com  
 
Source of Monetary or Material Support  
GOA MEDICAL COLLEGE, Bambolim, Panjim,North Goa,Goa -403202 
 
Primary Sponsor  
Name  Goa Medical College  
Address  Goa Medical College, Bambolim,Tiswadi,North Goa,Goa 403202 
Type of Sponsor  Government 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 
Anjali Rana  Goa Medical college   Operation theatre, Department of Anesthesia, Bambolim-403202
North Goa
GOA 		 9421597560

anjimbbs28@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Goa Medical College-Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications,  
 
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: 18-65years
2.ASA physical status : Class II
3.Patients undergoing elective surgeries
 
 
ExclusionCriteria 
Details  1.H/o difficult intubation
2.Edentulous
3.Midline neck swelling
4.Head and neck deformity
5.Pregnancy
6.Body Mass Index(BMI)>30kg/m2
7.Temporomandibular joint ankylosis 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
THE MOST SENSITIVE AIRWAY TESTS BETWEEN THE MODIFIED MALLAMPATI TEST,UPPER LIP BITE TEST AND THYROMENTAL HEIGHT TEST IN PREDICTING DIFFICULT LARYNGOSCOPY PRIOR TO INDUCTION   1week 
 
Secondary Outcome  
Outcome  TimePoints 
TO ASSESS WHETHER THE COMBINATION OF THE THREE TESTS WOULD IMPROVE THE ACCURACY OF AIRWAY ASSESSMENT  1week 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   24/09/2023 
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)   Not Yet Recruiting 
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   Patients will be examined in the pre-anaesthetic checkup and the 3 airway assessment tests, Modified Mallampati test(MMT), Upper Lip Bite Test(ULBT) and Thyromental Height test(TMHT) would be performed by the principal investigator not involved in performing the tracheal intubation and is then graded 
MMT: Sitting position, with the mouth fully open and tongue protruded out . 
ULBT: sitting position,patient is told to bite the upper lip with the lower teeth .
TMHT: supine position, the height between the anterior border of mentum to the thyroid prominence , the vertical height is measured. 
The patient is then taken for elective surgery and standard protocol is performed for induction of general anaesthesia , patient is preoxygenated with 100% oxygen for 3mins,and induced with iv fentanyl 1mcg/kg, iv propofol 1.5-2mg/kg and vecuronium 0.1mg/kg body weight .Consultant Anaesthesiologist, blinded from the preoperative assessment test results will  perform the intubation using the Macintosh Laryngoscope and will determine the best laryngeal view using Modified Cormack Lehane grading sysem.

Data collected will be anaysed using the SPSS Software to find out clinical and statistical significance. A p-value of >0.05 will be considered as statistically significant.
 
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