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CTRI Number  CTRI/2025/11/097631 [Registered on: 18/11/2025] Trial Registered Prospectively
Last Modified On: 18/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Crossover Trial 
Public Title of Study   Efficacy of Modified Thenar Eminence vs C-E Mask Ventilation Techniques in Unconscious Apnoeic Edentulous Patients Undergoing Induction of General Anaesthesia. 
Scientific Title of Study   To compare the efficacy of modified thenar eminence technique versus C-E technique of mask ventilation in unconscious apnoeic patients during induction of general anaesthesia in edentulous patients – a prospective 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  Dr NEVIL BALAR 
Designation  Resident Doctor 
Affiliation  Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre 
Address  Anaesthesia Department, General Ot Complex, 2nd Floor, Dhiraj Hospital, Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre, Waghodiya, Piparia, Vadodara GUJARAT 391760 India

Vadodara
GUJARAT
391760
India 
Phone  8160485474  
Fax    
Email  Balar.nevil1739@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Jatin Patel 
Designation  Professor  
Affiliation  Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre 
Address  Anaesthesia Department, General Ot Complex, 2nd Floor, Dhiraj Hospital, Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre, Waghodiya, Piparia, Vadodara GUJARAT 391760 India


GUJARAT
391760
India 
Phone  9879368363  
Fax    
Email  dr_jatinpatel@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr NEVIL BALAR 
Designation  Resident Doctor 
Affiliation  Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre 
Address  Anaesthesia Department, General Ot Complex, 2nd Floor, Dhiraj Hospital, Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre, Waghodiya, Piparia, Vadodara GUJARAT 391760 India
Anaesthesia Department, General Ot Complex, 2nd Floor, Dhiraj Hospital, Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre, Waghodiya, Piparia, Vadodara GUJARAT 391760 India

GUJARAT
391760
India 
Phone  8160485474  
Fax    
Email  Balar.nevil1739@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre 
Address  Waghodiya, Piparia ,Vadodara,GUJARAT,391760 
Type of Sponsor  Private 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 Nevil Balar  Smt Bhikiben Kanjibhai Shah Medical Institute and Research Centre  Anaesthesia Department, General Ot Complex, 2nd Floor, DhirajHospital, Smt.Bhikiben Kanjibhai Shah Medical Institute andResearch Centre, Waghodiya, Piparia,VadodaraGUJARAT391760India
Vadodara
GUJARAT 		 8160485474

Balar.nevil1739@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sumandeep Vidyapeeth Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy individuals. 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  C-E technique   For mask ventilation during preoxygenation in unconscious patients  
Intervention  Modified the air eminence technique   For mask ventilation before intubation  
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Patients willing to participate voluntarily and sign informed consent.
Male or female edentulous patients aged more than 60 years.
Patients belonging to American Society of Anesthesiologists (ASA) physical status I and II.
Patients posted for elective surgeries under general anaesthesia.
BMI between 18-30 kg/m² 
 
ExclusionCriteria 
Details  Patient not giving consent
Age less than 60 years
ASA grade 3,4,5 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the efficacy of modified thenar eminence technique vs C-E technique of mask ventilation in unconscious, apnoeic patients during induction under General Anaesthesia in edentulous patients   0 to 2 minutes 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the Peak airway pressure (PMAX).
To assess EtCO2. 		 0 to 2 minutes 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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   Phase 4 
Date of First Enrollment (India)   29/11/2025 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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   Bag-mask ventilation (BMV) is a vital airway management skill during induction of general anesthesia, as unconscious apneic patients depend entirely on effective ventilation. Its success relies on achieving a good mask seal and maintaining airway patency, which can be difficult in certain patient groups. The conventional one-handed C-E technique is widely used but often leads to mask leak or obstruction. Two-handed methods, especially the thenar eminence and modified thenar eminence techniques, offer better seal and jaw thrust. Given the 1–5% incidence of difficult mask ventilation and its serious complications, this study compares the efficacy of the modified thenar eminence versus C-E technique. 
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