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CTRI Number  CTRI/2025/03/082761 [Registered on: 19/03/2025] Trial Registered Prospectively
Last Modified On: 12/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Crossover Trial 
Public Title of Study   we are comparing how to hold the face mask in two different ways older and newer technique before the patient is given general anaesthesia  
Scientific Title of Study   Comparative study of newer mask ventilation Technique(thumb sealing and angle of mandible technique- tsam) with conventional thenar eminence Technique of mask ventilation during induction of General anesthesia - A randomized cross over study. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Meghana Lavu 
Designation  Post graduate student 
Affiliation  IMS and SUM hospital 
Address  Department of Anaesthesiology IMS and SUM hospital Bhubaneswar Khordha

Khordha
ORISSA
751003
India 
Phone  8328317217  
Fax    
Email  meghanalavu7@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Prerna Biswal 
Designation  Associate Professor 
Affiliation  IMS and SUM hospital 
Address  Department of Anaesthesiology IMS and SUM hospital Bhubaneswar Khordha

Khordha
ORISSA
751003
India 
Phone  9078671478  
Fax    
Email  prerna.biswal@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Prerna Biswal 
Designation  Associate Professor 
Affiliation  IMS and SUM hospital 
Address  Department of Anaesthesiology IMS and SUM hospital Bhubaneswar Khordha


ORISSA
751003
India 
Phone  9078671478  
Fax    
Email  prerna.biswal@gmail.com  
 
Source of Monetary or Material Support  
IMS and SUM hospital Siksha O Anusandhan University, Bhubaneswar, Khorda ,751003, India. 
 
Primary Sponsor  
Name  Institue of medical science and sum hospital 
Address  K8, Kalinganagar, Bhubaneswar, Odisha, 751003 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
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 Meghana lavu  IMS AND SUM HOSPITAL  Department of Anaesthesiology IMS and SUM hospital Bhubaneswar Khordha
Khordha
ORISSA 		 8328317217

meghanalavu7@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional ethics committee IMS and SUM hospital  Approved 
 
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 
Comparator Agent  conventional thenar mask ventilation technique  In this technique downward pressure is applied with thenar eminences of both hands while four fingers of each hand pull the jaw towards the mask, it leads to closure of mouth resulting in airway obstruction at the oropharynx. 
Intervention  Thumb sealing and angle of mandible mask ventilation technique(TSAM)  The jaw thrust will be applied to open the mouth, while maintaining the mouth in opening position, the assistant (PG resident) will keep the mask over the face. Then Anesthesiologists will give upward pressure by four fingers of both hands of angle of mandible to prevent tongue fall and both thumbs will provide downward and forward pressure at nasal part of mask providing better 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Adults between 18 and 60 years of age of
either sex undergoing general anesthesia and
belonging to ASA class 1 or 2. 
 
ExclusionCriteria 
Details  Patients belonging ASA class 3, 4, 5
Surgery on neck and oral cavity
Patients with maxillomandibular
deformities
Patients with full stomach
Patients with known gastro-esophageal
disorders
Emergency surgeries 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Compare efficacy of
newer mask ventilation technique in
improving expired tidal volume over
conventional thenar eminence mask
ventilation technique. 		 at baseline after first minute and after third minute 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the peak
airway pressure( P MAX) and ease of mask
ventilation between two techniques. 		 first five consecutive breaths in first minute and first five consecutive breaths in 3rd minute during mask ventilation. 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   28/03/2025 
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  
Mask ventilation is one of the necessary abilities required for successful airway management.
Maintenance of airway patency and oxygenation are major goals of mask ventilation. Difficult mask ventilation could happen in four out of 1000 patients. When the conventional mask ventilation is difficult, several alternative techniques have been described. One such technique is conventional thenar eminence. In this technique downward pressure is applied with thenar eminences of both hands while four fingers of each hand pull the jaw towards the mask, it leads to closure of mouth resulting in airway obstruction at the oropharynx. However, this obstruction could possibly be overcome by the use of an appropriately sized oro-pharyngeal airway. 

This may not be successful in all patients. In newer mask ventilation technique four finger of both hands used at angle of mandible to provide upward pressure that lift the mandible relieve tongue fall and both thumbs provide downward and forward pressure nasal part of mask providing better seal. We hypothesized that this proposed newer mask ventilation technique would result in increased ventilation in terms of expired tidal volume. 

This randomized crossover study designed to evaluate efficacy of newer mask ventilation technique against conventional thenar eminence mask ventilation technique.
 
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