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CTRI Number  CTRI/2024/07/071475 [Registered on: 29/07/2024] Trial Registered Prospectively
Last Modified On: 27/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To Find The Easier Method To Ventilate The Patient With A Face Mask Using These Conventional, Thenar Eminence, And Hook Methods. 
Scientific Title of Study   Comparision Of Effectiveness Of Single Handed Mask Ventilation By Conventional, Thenar Eminence And Hook Methods- A Randomised Clinical 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  Arakatla Asrith Reddy 
Designation  Junior Resident 
Affiliation  Shri B M Patil Medical college, Hospital and Research Center 
Address  Shri B M Patil Medical college, Hospital and Research Center, Solapur Road, Bangaramma Sajjan Campus, Vijayapura, KARNATAKA_586 103

Bijapur
KARNATAKA
586103
India 
Phone  9391067359  
Fax    
Email  asritharakatla@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Nirmala Devi 
Designation  Associate Professor 
Affiliation  Shri B M Patil Medical college, Hospital and Research Center 
Address  3rd Floor Ot Complex, Department Of Anaesthesiology, Shri B M Patil Medical college ,Hospital and Research Centre, Solapur Road, Vijayapura.

Bijapur
KARNATAKA
586103
India 
Phone  8217618954  
Fax    
Email  nirmalakagalkar77@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Nirmala Devi 
Designation  Associate Professor 
Affiliation  Shri B M Patil Medical college, Hospital and Research Center 
Address  3rd Floor Ot Complex, Department Of Anaesthesiology, Shri B M Patil Medical college ,Hospital and Research Centre, Solapur Road, Vijayapura.

Bijapur
KARNATAKA
586103
India 
Phone  8217618954  
Fax    
Email  nirmalakagalkar77@gmail.com  
 
Source of Monetary or Material Support  
Shri B M Patil Medical college, Hospital and Research Center,Solapur road, vijayapura, karnatka,586103, India. 
 
Primary Sponsor  
Name  Shri B M Patil Medical college Hospital and Research Center 
Address  3rd Floor Ot Complex, Department Of Anaesthesiology, Solapur Road, Vijayapura,Karnataka,586103,India. 
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 Nirmala Devi  Shri B M Patil Medical College and hospital   Department Of Anaesthesiology, Blde deemed to be university, Solapur Road, Vijayapura,Karnataka,India
Bijapur
KARNATAKA 		 8217618954

nirmalakagalkar77@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
BLDE (Deemed to be University) Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 8||Other Procedures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional(E/C)Technique  Conventional(E/C)Technique: A single person uses the E-C seal, in which the thumb presses down on the nasal bridge, while the first and second fingers create a "C" over the mask. The mandible is compressed to secure the mask firmly in place by the third through fifth fingers, forming the letter "E, for 90 seconds from the time of succinylcholine administration. 
Intervention  Hook Technique  Hook Technique: The The patients chin is guided upward by the resuscitators fingers as their hand is put in front of the mask pad, for 90 seconds from the time of succinylcholine administration. 
Comparator Agent  Thenar Eminence (T/E) Technique  Thenar Eminence (T/E) Technique: the thumb and thenar eminence are put on top of the mask, and the jaw push is carried out by the remaining fingers,for 90 seconds from the time of succinylcholine administration. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  General Anesthesia cases, ASA grade 1 and 2, Mallampati grade 1 and 2. 
 
ExclusionCriteria 
Details  Facial anomalies
Nasogastric tube
Significant burns
Pregnancy
Extensive beards and mustaches 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the effectiveness of mask ventilation by conventional method with hook and thenar eminence by ETco2.
 		 Intraoperatively After Intravenous Induction With Injection Propofol 2mg/Kg Etco2 is recoded for 1min(10 breaths given ) 
 
Secondary Outcome  
Outcome  TimePoints 
To Assess Quality Of Chest Rise  Intraoperatively After Intravenous Induction With Injection Propofol 2mg/Kg Chest Rise is assessed for 1 min(10 breaths)  
 
Target Sample Size   Total Sample Size="177"
Sample Size from India="177" 
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 3/ Phase 4 
Date of First Enrollment (India)   09/08/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  09/08/2024 
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 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   This Study Is To Determine Effective Single-Hand Mask Ventilation Among Conventional Method, Thenar Eminence, and Hook Methods In Terms Of End-Tidal Carbon Dioxide, For Resuscitation With Small Hands For A Prolonged Time Without Fatigue And Finger Discomfort.  
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