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CTRI Number  CTRI/2020/01/023050 [Registered on: 30/01/2020] Trial Registered Prospectively
Last Modified On: 29/07/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   This is a study to evaluate the role of ultrasound assessment of airway before surgery to predict difficulty in mask ventilation under anesthesia  
Scientific Title of Study   To evaluate the role of pre-operative ultrasound assessment of airway in predicting difficult mask ventilation.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vishrantkumar k kushal shetty 
Designation  Doctor 
Affiliation  Maulana Azad Medical College, New Delhi. 
Address  Dept of Anesthesia, Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi-110002
Dept of Anesthesia, Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi-110002
New Delhi
DELHI
110002
India 
Phone  9110841070  
Fax    
Email  vishranth8@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Kapil Chaudhary 
Designation  Doctor 
Affiliation  Maulana Azad Medical College, New Delhi. 
Address  B L Taneja Block, Dept of Anesthesia, Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi-110002

New Delhi
DELHI
110002
India 
Phone  9871262699  
Fax    
Email  kapsdr@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Vishrantkumar k kushal shetty 
Designation  Doctor 
Affiliation  Maulana Azad Medical College, New Delhi. 
Address  Dept of Anesthesia, Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi-110002
Dept of Anesthesia, Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi-110002
New Delhi
DELHI
110002
India 
Phone  9110841070  
Fax    
Email  vishranth8@gmail.com  
 
Source of Monetary or Material Support  
Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi-110002 
 
Primary Sponsor  
Name  Maulana Azad Medical College 
Address  Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi 110002 
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 
Vishrantkumar K Kushal Shetty  Maulana Azad Medical College  Dept of Anesthesia, Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi-110002
New Delhi
DELHI 
9110841070

vishranth8@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Maulana Azad Medical College  Approved 
Maulana Azad Medical college  Not Applicable 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Patients scheduled for surgery under general anesthesia requiring mask ventilation after 1 minute of administration of neuro-muscular blockade.
2. American Society Of Anesthesiologists Physical Grade I, II, III. 
 
ExclusionCriteria 
Details  1. Patients in whom achieving a proper mask seal
will be difficult including but not limited
to edentulous, beard, scars, swellings,
dressings over the face.
2. Patients requiring awake intubation.
3. Patients requiring rapid sequence intubation.
4. Pregnant woman.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Association between ultrasound measurement of tongue thickness to oral cavity height (TT/OCH) ratio and difficult mask ventilation (DMV).
 
During mask ventilation after 1 minute of administration of muscle relaxant. 
 
Secondary Outcome  
Outcome  TimePoints 
1. Association between anterior neck measurements by ultrasound and difficult mask ventilation (DMV).
2. Association between tongue thickness by ultrasound to thyromental distance ratio and DMV.
3. Comparison between prediction of DMV by known clinical parameters and ultrasound parameters.
 
During mask ventilation after 1 minute of administration of muscle relaxant. 
 
Target Sample Size
Modification(s)  
Total Sample Size="102"
Sample Size from India="102" 
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)   01/02/2020 
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)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Effective mask ventilation plays a critical role in safe management of airway before intubation or after failed intubation. Failure to provide adequate oxygenation resulting from difficult mask ventilation (DMV) can lead to life threatening complications in both elective and emergency settings. Thus, it is very important to identify patients at risk of DMV. Prediction of DMV based on clinical evaluation of anesthesiologist alone is not always accurate and may lead to unanticipated DMV. This necessitates the need for diagnostic tools which may be considered adjunct to the conventional pre-operative assessment in predicting DMV and can contribute to safer airway management.

During the last few years ultrasound has been used widely in the operating room for ultrasound guided procedures such as nerve block or central venous access. It has been suggested that pre-operative ultrasound measurement of airway when combined with commonly used screening tests and risk factor assessment for DMV might improve the ability to predict the difficulties.

Previous studies have found the anterior neck measurements using ultrasound to be associated with DMV, especially the distance from skin to hyoid bone (DSHB). Ultrasound measurement of tongue thickness to oral cavity height ratio (TT/OCH) has been observed to be consistent with CT findings of tongue volume to oropharyngeal volume ratio and tongue thickness to oral cavity height ratio.

Under general anesthesia, the tongue may obstruct the upper airway by pushing the soft palate against the posterior pharyngeal wall, obstructing both the nasal and oral cavities or the tongue may close the oral cavity when the nose is obstructed, then acting as a one-way valve obstructing expiration. Thickness of tongue relative to oral cavity height may predispose to upper airway obstruction and result in DMV. Thus, we thought it would be worthwhile to study the role of ultrasound measurement of tongue thickness to oral cavity height (TT/OCH) ratio in predicting DMV. So, we aim to evaluate the role of ultrasound guided TT/OCH ratio and anterior neck measurements in predicting DMV.

 
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