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CTRI Number  CTRI/2021/04/033129 [Registered on: 26/04/2021] Trial Registered Prospectively
Last Modified On: 26/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Different methods for prediction of difficult mask holding and insertion of tube in breathing pipe 
Scientific Title of Study   Evaluation of Acromio-axillo-suprasternal notch index, upper lip bite test and ratio of height to thyromental distance for prediction of difficult mask ventilation and difficult intubation 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prerana Nirav Shah 
Designation  Professor (Additional) 
Affiliation  GSMC & KEMH 
Address  Department of Anaesthesiology 1st Floor Old Building GSMC KEMH Parel Mumbai Maharashtra 400012 India Mumbai MAHARASHTRA 400012 India

Mumbai
MAHARASHTRA
400012
India 
Phone  9869117027  
Fax    
Email  pps@kem.edu  
 
Details of Contact Person
Scientific Query
 
Name  Swekchha Jain 
Designation  Resident 
Affiliation  GSMC & KEMH 
Address  Department of Anaesthesiology 1st Floor Old Building GSMC KEMH Parel Mumbai Maharashtra 400012 India Mumbai MAHARASHTRA 400012 India

Mumbai
MAHARASHTRA
400012
India 
Phone  8770028931  
Fax    
Email  swekchha0401.jain@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Swekchha Jain 
Designation  Resident 
Affiliation  GSMC & KEMH 
Address  Department of Anaesthesiology 1st Floor Old Building GSMC KEMH Parel Mumbai Maharashtra 400012 India Mumbai MAHARASHTRA 400012 India


MAHARASHTRA
400012
India 
Phone  8770028931  
Fax    
Email  swekchha0401.jain@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology 1st Floor Old Building GSMC KEMH Parel Mumbai Maharashtra 400012 India  
 
Primary Sponsor  
Name  GSMC KEMH 
Address  Department of Anaesthesiology 1st Floor Old Building GSMC KEMH Parel Mumbai Maharashtra 400012 India  
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 
SWEKCHHA JAIN  GSMC KEMH  Department of Anaesthesiology 1st Floor Old Building GSMC KEMH Parel Mumbai Maharashtra 400012 India
Mumbai
MAHARASHTRA 
8770028931

SWEKCHHA0401.JAIN@GMAIL.COM 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee IEC-IIi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z00-Z99||Factors influencing health status and contact with health services,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1) Age: 18-65 years
2) Patients of both genders
3) Patients undergoing all kind of elective surgeries under general anaesthesia requiring endotracheal intubation
4) American Society of Anesthesiologists grade I and II
 
 
ExclusionCriteria 
Details  1) Patients not willing to participate in study.
2) Patients with insitu endotracheal tube.
3) Pregnant women
4) Patients with neck burns contracture, and history of neck surgery
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Evaluation of Acromio-axillo-suprasternal notch index ( AASI), upper lip bite test ( ULBT) and ratio of height to thyromental distance (RHTMD) for predicting difficult mask ventilation and difficult intubation.  Day prior to surgery
This is baseline 
 
Secondary Outcome  
Outcome  TimePoints 
• Duration of laryngoscopy,
• Duration of intubation and
• Number of attempts for successful intubation
 
On day of surgery 
Duration of laryngoscopy
Duration of intubation
Number of attempts for successful intubation 
On day of surgery.

 
 
Target Sample Size   Total Sample Size="194"
Sample Size from India="194" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   30/04/2021 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Airway assessment before any type of anaesthesia is mandatory. Failure to maintain a patent airway after induction of anaesthesia leads to irrevocable catastrophic sequelae such as brain damage or death. Maintaining a patent airway is essential for adequate oxygenation and ventilation and failure to do so, even for a brief period of time, can be life threatening that significantly increases the morbidity and mortality of general anaesthesia. Ability to ventilate the patient with bag and mask is extremely important in the unfortunate scenario of inability to intubate. We find that intubation may be easy even though mask ventilation is difficult. There are many bed side tests to assess difficult airway and mask ventilation which are easy to perform and need no special equipment. But all these tests have limitations and no single one is complete. No single airway test can provide a high index of sensitivity and specificity for prediction of difficult airway. Therefore, it has to be a combination of multiple tests.

The primary aim of this study is to evaluate acromio-axillo-suprasternal notch index, upper lip bite test and ratio of height to thyromental distance for prediction of difficult mask ventilation and difficult intubation.

 
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