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CTRI Number  CTRI/2023/11/060120 [Registered on: 22/11/2023] Trial Registered Prospectively
Last Modified On: 20/11/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   To differentiate the preoperative airway and compare with intubation findings.  
Scientific Title of Study   A Comparative Study Of Thyromental Height With Upper Lip Bite Test and Modified Mallampati Classification Test In Predicting Difficult Laryngoscopy  
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 Lairenjam Deepa Devi 
Designation  Post Graduate in Department of Anaesthesiology 
Affiliation  Rajarajeswari Medical college and hospital 
Address  Department Of Anaesthesiology Rajarajeswari Medical College And Hospital, Mysore Road, Kambipura, Bangalore Karnataka 560074, India

Bangalore
KARNATAKA
560074
India 
Phone  6239217231  
Fax    
Email  chaolai91@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sowmya Jois 
Designation  Associate Professor 
Affiliation  Rajarajeswari Medical College and Hospital 
Address  Department Of Anaesthesiology Rajarajeswari Medical College And Hospital, Mysore Road, Kambipura, Bangalore, Karnataka 560074,India

Bangalore
KARNATAKA
560074
India 
Phone  9980891082  
Fax    
Email  Drsowmyasharma@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sowmya Jois 
Designation  Associate Professor 
Affiliation  Rajarajeswari Medical College and Hospital 
Address  Department Of Anaesthesiology Rajarajeswari Medical College And Hospital, Mysore Road, Kambipura, Bangalore, Karnataka 560074,India

Bangalore
KARNATAKA
560074
India 
Phone  9980891082  
Fax    
Email  Drsowmyasharma@gmail.com  
 
Source of Monetary or Material Support  
Department Of Anaesthesiology, 2nd floor, Rajarajeswari Medical College and Hospital, Bangalore-560074 
 
Primary Sponsor  
Name  Dr Lairenjam Deepa Devi 
Address  RajaRajeswari Medical College And Hospital202, Mysore Road, Kambipura, Bangalore Karnataka 560074, India 
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 Lairenjam Deepa Devi  Rajarajeswari Medical College and Hospital  Rajarajeswari Medical college and Hospital 202, Mysore road kengeri satelliite town kambipura,Bangalore karnataka 560074,India
Bangalore
KARNATAKA 		 6239217231

chaolai91@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethic committe  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J958||Other intraoperative and postprocedural complications and disorders of respiratory system, not elsewhere classified,  
 
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. Patient undergoing elective surgeries under general anaesthesia with endotracheal intubation.
2. ASA 1 and 2 of either sex.
 
 
ExclusionCriteria 
Details  1. Patient not willing to participate in the study.
2. ASA 3 and 4.
3. Facial anamolies and anamolies of the nose, mouth and tongue.
4. Pathology of larynx and pharynx.
5. History of burns and contracture.
6. Temporomandibular joint pathology.
7. Patient undergoing emergency surgery.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
The primary aim of this study will be to predict difficult laryngoscopy by comparing Cormac Lehane grading with Thyro-mental height test, Upper Lip Bite test & Modified Mallampati test.  to study the duration at preoperatively 0min,10min 
 
Secondary Outcome  
Outcome  TimePoints 
To compare their assessment with Cormack Lehane grading & predict the difficulty of laryngoscopy & intubation.   to study the duration at 0min,10 min 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   30/11/2023 
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="10"
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 incidence of difficult laryngoscopy and intubation occurs in 1.5% to 8% of patient in general anaesthesia. Difficult laryngoscopy can be assessed prior to operation by various tests like Modified Mallampati Test , Upper Lip Bite Test, Thyromental distance, Sternomental distance, Ratio of height to thyromental distance. Many pre-operative airway assessment test may be used to predict difficult intubations, but sensitivity and positive predictive value of these individual tests are low while false positive results are high. In our study we will be comparing Thyromental height test , Modified Mallampati test, Upper Lip bite test and compare it with Cormack Lehane grading to predict difficult airway. 
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