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CTRI Number  CTRI/2024/06/068350 [Registered on: 05/06/2024] Trial Registered Prospectively
Last Modified On: 29/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   New mask ventilation technique in obese patients for general anaesthesia 
Scientific Title of Study   Efficacy of novel EP technique of mask ventilation versus standard CE technique in obese patients for general anaesthesia 
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 Murshida U C 
Designation  Junior resident doctor 
Affiliation  Lokmanya Tilak Municipal General Hospital and medical college 
Address  4th floor,Department of Anaesthesiology,College building,Lokmanya Tilak Municipal Medical COollege,Sion,Mumbai 400022

Mumbai
MAHARASHTRA
400022
India 
Phone  9096978277  
Fax    
Email  murshidauc121@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Urvi H Desai 
Designation  Associate Professor 
Affiliation  Lokmanya Tilak Municipal General Hospital and medical college 
Address  4th floor,Department of Anaesthesiology,college building,Lokmanya Tilak municipal medical college,Sion,Mumbai 400022

Mumbai
MAHARASHTRA
400022
India 
Phone  9821598190  
Fax    
Email  urvi_desai@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Murshida U C 
Designation  Junior resident doctor 
Affiliation  Lokmanya Tilak Municipal General Hospital and medical college 
Address  4th floor,Department of Anaesthesiology,college building,Lokmanya Tilak Municipal medical college,Sion,Mumbai 400022

Mumbai
MAHARASHTRA
400022
India 
Phone  9096978277  
Fax    
Email  murshidauc121@gmail.com  
 
Source of Monetary or Material Support  
Lokmanya Tilak Municipal General Hospital and Medical College,Sion,Mumbai 400022 
 
Primary Sponsor  
Name  Lokmanya Tilak Municipal General Hospital and Medical CollegeSionMumbai 
Address  Lokmanya Tilak Municipal General Hospital and Medical College,Sion west,Mumbai 400022 
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 
Dr Murshida U C  Lokmanya Tilak Municipal General Hospital and Medical College  4th floor,Department of Anaesthesiology,college building,Lokmanya Tilak Municipal General Hospital and Medical College,Sion west,Mumbai 400022
Mumbai
MAHARASHTRA 
9096978277

murshidauc121@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Human Research,Lokmanya Tilak Municipal Medical College and General Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E669||Obesity, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients of more than 18 years whose BMI is more than 30 kg/m2 
 
ExclusionCriteria 
Details  1.Emergency surgery requiring RSI
2.Pregnant women 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine the effectiveness of EP
technique in obese adult population of mask ventilation in elective
and emergency surgeries as compared to standard CE technique
by evaluating the following parameters
1.Chest expansion(yes/no)
2.Capnography in numbers(35-40)
3.Inhaled and Exhaled Tidal Volume in ml
4.Peak airway pressure in mmhg 
at baseline 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the failure rate of mask Ventilation for general anaesthesia by CE & EP technique   at baseline 
 
Target Sample Size   Total Sample Size="74"
Sample Size from India="74" 
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)   21/06/2024 
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="0"
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   Mask ventilation is the primary technique of ventilation before intubation or insertion of any airway devices during general anaesthesia.It is also a rescue technique for ventilation during unsuccessful attempts at intubation and difficult airway situations. There can be several factors contributing to inadequate mask ventilation that can be classified as patient related (such as beard, edentulous, thick neck),equipment related (inappropriate size mask ,non cushioned rim of the masks) or operator related factors (inexperience ,improper technique).
Airway management is more challenging in obese patients. They have impaired respiratory mechanics, decreased FRC and vital capacity ,increased airway resistance and reduced oxygen reserve. Maintaining airway  patency may be difficult in obese patients due to high collapsibility of upper airway structures and technical difficulty in applying the mask. Sustained effective mask ventilation becomes difficult in obese patient due to strain because of the heavy jaw and large neck circumference causing fatigue to the operator. 
In order to tackle these difficulties we are studying an alternative novel technique which is a variant of VE technique named as EP technique. This technique provides a better seal and is an easy and strain free method than the standard CE technique that we use in mask ventilation .The CE technique applies the mask by forming a C shape with each thumb and index finger over each side of the mask while the third ,fourth and fifth fingers of both hands lift the mandible towards the mask in a three fingered E shape .In contrast, the EP technique uses each thumb over the mask which pushes the mask down to provide a better seal, while the second to fourth digits are along the mandible like an E that pull it upwards and the little finger behind the pinna for a better grip ,support and stability .This will not only improve the quality of ventilation ,ie, oxygenation and outcomes but also makes the operator fatigue free
 
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