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CTRI Number  CTRI/2022/01/039710 [Registered on: 25/01/2022] Trial Registered Prospectively
Last Modified On: 16/02/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Crossover Trial 
Public Title of Study   Aim of the study is to find out the effect of different flow rates of oxygen provided through nasal prongs in addition to face mask on the quality of preoxygenation  
Scientific Title of Study   Comparative evaluation of different oxygen flow rates through nasal cannula on the efficacy of preoxygenation 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kapil Chaudhary 
Designation  Associate Professor 
Affiliation  Maulana Azad Medical College 
Address  Department of Anaesthesia 3rd floor, B L Taneja Block Lok Nayak Hospital New Delhi

Central
DELHI
110002
India 
Phone  9871262699  
Fax    
Email  kapsdr@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Kapil Chaudhary 
Designation  Associate Professor 
Affiliation  Maulana Azad Medical College 
Address  Department of Anaesthesia 3rd floor, B L Taneja Block Lok Nayak Hospital New Delhi


DELHI
110002
India 
Phone  9871262699  
Fax    
Email  kapsdr@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Kapil Chaudhary 
Designation  Associate Professor 
Affiliation  Maulana Azad Medical College 
Address  Department of Anaesthesia 3rd floor, B L Taneja Block Lok Nayak Hospital New Delhi


DELHI
110002
India 
Phone  9871262699  
Fax    
Email  kapsdr@yahoo.com  
 
Source of Monetary or Material Support  
Maulana Azad Medical College 
 
Primary Sponsor  
Name  Maulana Azad Medical College 
Address  Maulana Azad Medical College New Delhi 110002 
Type of Sponsor  Government 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 Kapil Chaudhary  Lok Nayak Hospital  3rd floor, B L Taneja Block Department of Anaesthesiology Lok Nayak Hospital New Delhi 110002
Central
DELHI 		 9871262699

kapsdr@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Maulana Azad Medical College  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  FM only  Well Sealed face mask only 
Intervention  NC 0  Face mask and nasal prong with no oxygen flow 
Intervention  NC 10  Face mask and nasal prong with oxygen at 10L/min 
Intervention  NC 5  Face mask and nasal prong with oxygen at 5L/min 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients scheduled for elective surgery under anaesthesia 
 
ExclusionCriteria 
Details  Known lung disease
Suspected coronary and cerebrovascular disease
Previous exposure to bleomycin or amiodarone
Pregnancy
BMI>35
Pathological abdominal distention
Factors affecting mask seal like beard, moustache, dentures or facial abnormalities 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
End tidal oxygen concentration after 3 mins of preoxygenation in well-sealed face mask and in a combination of both face mask and nasal cannula (at flow rates of 0L/min, 5L/min and 10L/min  3 minute 
 
Secondary Outcome  
Outcome  TimePoints 
End tidal oxygen concentration after 1 and 2 mins of preoxygenation in well-sealed face mask and in a combination of both face mask and nasal cannula (at flow rates of 0L/min, 5L/min and 10L/min  1 minute
2 minute 
 
Target Sample Size   Total Sample Size="54"
Sample Size from India="54" 
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)   01/02/2022 
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)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Preoxygenation is a critical component of airway management wherein the patient is made to breathe 100% oxygen to denitrogenate the functional residual capacity of lungs and create adequate oxygen reservoir. However, a tight seal required for ideal preoxygenation is not always possible due to factors such as emergency scenarios, facial traumas, patients with beard, uncooperative or edentulous patients or lack of specialized circuits. A nasal cannula is often used during apneic oxygenation and its addition to face mask while preoxygenation can improve its efficacy. Oxygen at a flow rate of 0 and 5 L/min has been found to be deleterious due to room air entrainment while a flow rate of 10 L/min has shown no impairment of preoxygenation process. Hence, we are conducting this study to compare and evaluate different oxygen flow rates supplied through a nasal cannula on the efficacy of preoxygenation.  
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