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CTRI Number  CTRI/2025/08/093604 [Registered on: 25/08/2025] Trial Registered Prospectively
Last Modified On: 23/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [PROSPECTIVE RANDOMISED DOUBLE BLINDED CLINICAL TRIAL]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparing the two techniques of bag mask ventilation traditional two handed E and C technique with non dominant hand E and C dominant hand thenar eminence technique  
Scientific Title of Study   Comparision between two techniques of bag mask ventilation - traditional two-handed E-C technique and non-dominant hand E-C and dominant hand thenar eminence technique.A prospective randomised double blind trial. 
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 Madhushree 
Designation  Junior Resident  
Affiliation  Karnataka Medical College and Research Institute,Hubballi 
Address  Department of Anesthesiology,Room no 206,IP Division KMCandRI PB road Vidyanagar Hubballi Karnataka

Dharwad
KARNATAKA
580022
India 
Phone  9945372316  
Fax    
Email  mshree.v05@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR Pushpavathi S H 
Designation  Associate Professor  
Affiliation  Karnataka Medical College and Research Institute  
Address  Department of Anaesthesia,Room no 206,IP division KMCandRI PB road vidyanagar Hubballi Karnataka

Dharwad
KARNATAKA
580022
India 
Phone  9448251597  
Fax    
Email  pushpadrture@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  DR Madhushree 
Designation  Associate Professor  
Affiliation  Karnataka Medical College and Research Institute  
Address  Department of Anesthesiology,Room no 206,IP Division KMCandRI PB road Vidyanagar Hubballi Karnataka

Dharwad
KARNATAKA
580022
India 
Phone  9448251597  
Fax    
Email  pushpadrture@rediffmail.com  
 
Source of Monetary or Material Support  
Karnataka Medical College and Research Institute, Department of Anesthesiology,Room no 206, IP building division, Vidyanagar, Hubballi, Karnataka, India 580022 
 
Primary Sponsor  
Name  DR MADHUSHREE 
Address  Karnataka Medical College and Research Institute, Department of Anesthesiology,Room no 206, IP building division, Vidyanagar, Hubballi, Karnataka, India 580022 
Type of Sponsor  Government 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 MADHUSHREE  Karnataka Medical College and Research Institute, Hubballi   Karnataka Medical College and Research Institute, Department of Anesthesiology, Room no 206,IP Building division, Hubballi, India - 580022
Dharwad
KARNATAKA 		 9945372316

mshree.v05@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KARNATAKA MEDICAL COLLEGE AND RESEARCH INSTITUTE HUBBALLI ETHICS COMMITTEE   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H652||Chronic serous otitis media, (2) ICD-10 Condition: 4||Measurement and Monitoring, (3) ICD-10 Condition: 4||Measurement and Monitoring,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Comparator Agent  Non dominant hand E and C, dominant hand thenar eminence technique  33 patients will receive bag and mask ventilation by non dominant hand E and C, dominant hand thenar eminence technique.  
Intervention  Two Handed E and C technique of mask ventilation  33 patients will receive mask ventilation by two handed E and C technique 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Age 18-60 years undergoing elective surgery.
American society of anaesthesiology physical status class 1 and class 2.
Informed written valid consent from patient.
 
 
ExclusionCriteria 
Details  Emergency surgery
Induction requiring rapid sequence for intubation
Edentulous patients
Pregnant women
Patients requiring an awake intubation
Patients with cervical spine injuries  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
End tidal CO2 in mmHG  At 60,120,180 seconds after the administration of the neuromuscular blocking agent. 
 
Secondary Outcome  
Outcome  TimePoints 
1.Comparision of leak fraction between two techniques.
2.Use of airway manuevers and airway adjuncts.
3.Hemodynamics:Pulse rate, saturation,systolic blood pressure and diastolic blood pressure.
4.Adverse events like desaturation, tachycardia, hypotension. 		 1.At 60,120 and 180 seconds after the administration of neuromuscular blocking agents
3. At 60,120 and 180 seconds after the administration of neuromuscular blocking agents
4. At 60,120 and 180 seconds after the administration of neuromuscular blocking agents 
 
Target Sample Size   Total Sample Size="66"
Sample Size from India="66" 
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)   05/09/2025 
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="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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) - 

  6. For how long will this data be available start date provided 05-08-2025 and end date provided 05-08-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   Bag-Mask ventilation plays a pivotal role in managing emergency airway situations as well as facilitating general anaesthesia. Despite its apparent simplicity, Bag-Mask ventilation demands precision and expertise. It requires skilled operator who can securely position an appropriate size mask and administer the requisite positive pressure. 
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