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CTRI Number  CTRI/2024/08/073121 [Registered on: 29/08/2024] Trial Registered Prospectively
Last Modified On: 25/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   To study the commonness of Difficult endotracheal intubation with clinical screening tests and ultrasonographic measurement of anterior neck soft tissue and to assess the Connection between two modalities. 
Scientific Title of Study   Prevalence of Difficult endotracheal intubation with clinical screening tests and ultrasonographic measurement of anterior neck soft tissue and to assess the Correlation between two modalities for prediction of difficult endotracheal intubation. 
Trial Acronym  DICUSGANS 
Secondary IDs if Any  
Secondary ID  Identifier 
05092023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Venkatesh Mongam 
Designation  Post Graduation Resident 
Affiliation  INHS Asvini 
Address  Cabin number 6, ward roommess, Department of Anaesthesiology, g 3rd Floor, OT Division, INHS Asvini, Colaba, Mumbai

Mumbai
MAHARASHTRA
400005
India 
Phone  9502500414  
Fax    
Email  venki12361@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Vidhu Bhatnagar 
Designation  Head of the Department 
Affiliation  Institute of Naval Medicine , INHS Asvini 
Address  HOD Room, Department of Anaesthesiology, 3rd floor, OT Division, INHS Asvini, Colaba, Mumbai

Mumbai
MAHARASHTRA
400005
India 
Phone  9969777168  
Fax    
Email  vizardsvids@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Vidhu Bhatnagar 
Designation  Head of the Department 
Affiliation  Institute of Naval Medicine , INHS Asvini 
Address  Department of Anaesthesiology, 3rd floor, INHS Asvini, Colaba, Mumbai

Mumbai
MAHARASHTRA
400005
India 
Phone  9969777168  
Fax    
Email  vizardsvids@gmail.com  
 
Source of Monetary or Material Support  
Institute of Naval Medicine, INHS Asvini 
 
Primary Sponsor  
Name  Venkatesh Mongam 
Address  Cabin room number 6, Ward room mess, Department of Anaesthesiology, 3rd floor, OT division, INHS Asvini, Colaba, Mumbai 
Type of Sponsor  Other [Individual] 
 
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 
Venkatesh Mongam  institute of Naval Medicine, INHS Asvini   Resident Room, Department of Anaesthesiology, 3rd floor, OT division, INHS Asvini, Colaba, Mumbai, 400005
Mumbai
MAHARASHTRA 
9502500414

venki12361@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INHS ASVINI Ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Individuals who are planned for Elective Surgery under General Anaesthesia 
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  65.00 Year(s)
Gender  Both 
Details  ASA grade 1 and 2
Undergoing Elective Surgery under General Anaesthesia  
 
ExclusionCriteria 
Details  Patient refusal to give consent
Patients with Cardio respiratory problems
Patients wit cervical spine fractures
Contraindications to General Anaesthesia
Patients with psychiatric disease
Pregnant ladies, hiatus hernia, GERD, history of difficult intubation
ASA 3 and above
Patients taken for surgery under General Anaesthesia in emergency
Patients with inhalational burn injuriy
Patients with post burn contractures in neck and face area
Patients with history of prior tracheostomy or any airway Surgery 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To establish the prevalence of difficult endotracheal intubation with clinical screening tests and ultrasonographic measurement of anterior neck soft tissue and assess the correlation between two modalities for prediction of difficult endotracheal intubation.  I would like like collect my data for next 1year 4months 
 
Secondary Outcome  
Outcome  TimePoints 
Ultrasonographic measurement of anterior neck soft tissue thickness can reveal unecpected hidden details which might be useful to my study.  Since my study is an observational study my secondary come also expected in the same time that is in next 1 Year 4months. 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   15/09/2024 
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  
 Prediction of difficult intubation through evaluation of the airway is very important in the practice of anaesthesia. There are several clinical predictors for assessing difficult airways. However due to the low reliability of traditional protocols, algorithms and combinations of screening tools, the rate of difficult laryngoscopy and tracheal intubation remains at 1.5–13 per cent for the identification of potentially difficult airways. An unexpectedly difficult airway is even a terrible nightmare for an experienced anaesthesiologist, as it can cause morbidity and mortality associated with anaesthesia that threaten life. The aetiology of difficult airways is multifaceted and should require detailed clinical history and physical examination. However, most clinical predictors have low sensitivity and moderate specificity. The prevalence of difficult/invalid intubations in the general population is low, and the positive prediction value (PPV) is therefore also low. Although there are several multivariate scoring systems that increase the PPV compared to single tests, prediction scores remain low and many failures are not expected to occur as all airway management techniques can fail. Thus, any tool that improves airway assessment will be extremely valuable for the safe practice of anaesthesia. Though X-ray, Computerised tomography (CT) scan and Magnetic Resonance Imaging (MRI) have been used to study airway and predict difficult intubation, their size, radiation risk and cost limits their routine use. With the improvement of the visualization of airways structures, more studies have focused on airway structure and function. the Ultrasonography (US) can reliably visualize all structures visualized by CT and that  the parameters of the infra-hyoid airway structure measured by ultrasound are well compatible with the parameters measured by CT. The present study aimed to assess the utility of ultrasonographic measurements of anterior soft tissue neck thickness at the level of vocal cords, thyroid isthmus, and sternal notch in determining difficult endotracheal intubation. We will examine the correlation of clinical screening tests, ultrasonic measurements, and laryngoscopic view (Cormack Lehane grade) to distinguish between easy and difficult endotracheal intubation. With this study  i would like to estimate the Prevalence of difficult endotracheal intubation and Is there any correlation between clinical screening tests for airway and ultrasonographic measurement of anterior neck soft tissue for prediction of difficult endotracheal intubation. My primary hypothesis is there is no difference between clinical screening tests and ultrasonographic measurements to establish the Prevalence of difficult endotracheal  intubation.

 


 
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