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CTRI Number  CTRI/2025/07/092088 [Registered on: 31/07/2025] Trial Registered Prospectively
Last Modified On: 09/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of two hand chin lift vs Hybrid mask technique for breathing support by new learner’s in adults under anaesthesia  
Scientific Title of Study   Comparison of two hand C-E with hybrid mask ventilation techniques by novice airway providers in adult patients under 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 Payal Pandya 
Designation  Doctor (Resident) 
Affiliation  ABVIMS and Dr RML hospital New Delhi  
Address  Department of anaesthesia ABVIMS and Dr RML hospital New Delhi

New Delhi
DELHI
110001
India 
Phone  8839633180  
Fax    
Email  Pandyapayal12@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sangeeta Yadav  
Designation  Associate professor  
Affiliation  ABVIMS and Dr RML hospital  
Address  Department of anaesthesia ABVIMS and Dr RML hospital New Delhi

New Delhi
DELHI
110001
India 
Phone  9871386600  
Fax    
Email  Sangiydv80@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sujali nang chupoo 
Designation  Associate professor  
Affiliation  ABVIMS and Dr RML hospital 
Address  Department of anaesthesia ABVIMS and Dr RML hospital New Delhi

New Delhi
DELHI
110001
India 
Phone  8587887234  
Fax    
Email  Sujalichoupoo@yahoo.com  
 
Source of Monetary or Material Support  
Department of anaesthesia , ABVIMS and Dr RML hospital , baba kharak singh marg, New Delhi, Delhi, India, pin 110001 
 
Primary Sponsor  
Name  ABVIMS and Dr RML Hospital 
Address  Room no 301, Department of anaesthesia, Third floor, ABVIMS and Dr RML hospital, New Delhi, Delhi, India, 110001 
Type of Sponsor  Research institution and hospital 
 
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 Payal Pandya   ABVIMS and Dr RML hospital   Room no 301 department of anaesthesia third floor ABVIMS and Dr RML hospital New Delhi pin 110001 India
New Delhi
DELHI 
8839633180

Pandyapayal12@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, ABVIMS and Dr RML 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 
Intervention  Hybrid mask ventilation technique   Two hand Hybrid mask ventilation technique performed by novice airway providers under general anaesthesia in adult patients 
Comparator Agent  Standard two hand C-E technique   Traditional C-E hand position for mask ventilation technique using two hands by novice airway providers in adult patients under general anaesthesia  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA class I and II
Patients posted for elective surgery under general anaesthesia
Modified Mallampti grade I and II 
 
ExclusionCriteria 
Details  Patients which predictors of difficult mask ventilation that is edentulous, beard, history of snoring, old age, BMI greater than 30  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
2 minutes or 24 breaths mean exahaled tidal volume in both groups   2 minutes or 24 breaths mean exahaled tidal volume in both groups  
 
Secondary Outcome  
Outcome  TimePoints 
Number of failed breaths reflected by no exhaled tidal volume & operator comfort based on 5 point likert scale   Total no of failed breaths at one minute two minutes & three minutes from baseline  
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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 2/ Phase 3 
Date of First Enrollment (India)   15/08/2025 
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="5"
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  

The study will be conducted following approval from the Institutional Ethical and Scientific Review Committee. All enrolled patients will undergo a routine pre-anesthetic checkup, including medical history, physical examination, and airway assessment. Adequate fasting status will be ensured, and informed written consent will be obtained in a language understood by the patient.Participants will be randomly assigned to one of two groups (Group A or B) using computer-generated randomization, with group assignments concealed in sequentially numbered opaque envelopes.Upon arrival in the operating room, standard monitoring (pulse oximetry, 5-lead ECG, and non-invasive blood pressure) will be initiated, and baseline parameters including heart rate, systolic and diastolic blood pressure, and oxygen saturation will be recorded.An intravenous line will be secured, and premedication with IV midazolam (0.05 mg/kg) will be administered. Each patient will receive pre-oxygenation with 100 percent oxygen at 10 L/min for 3 minutes using a well-fitting transparent face mask.General anesthesia will be induced using IV propofol (2 mg/kg), IV fentanyl (2 mcg/kg), and IV vecuronium (0.1 mg/kg). Mechanical ventilation will be set in pressure-controlled mode (peak pressure 15 cm H2O, no PEEP, 12 breaths per minute, I:E ratio 1:2).A consultant anesthesiologist will perform mask ventilation for the first minute to confirm adequacy, then hand over to a novice airway provider (less than 3 years of experience) for 2 minutes of ventilation using the allocated technique—either two-hand C-E or hybrid (dominant hand C-E and non-dominant hand thenar eminence). An independent observer will record parameters such as exhaled tidal volume and oxygen saturation.If oxygen saturation drops below 94 percent or there is any hemodynamic instability, the consultant anesthesiologist will intervene immediately to ensure patient safety. After the study period, the anesthesiologist will proceed with standard care.Study Aim is to compare the effectiveness of the two-hand C-E technique and the hybrid mask ventilation technique when performed by novice airway providers in adult patients under general anesthesia.


 
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