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CTRI Number  CTRI/2023/08/056118 [Registered on: 04/08/2023] Trial Registered Prospectively
Last Modified On: 03/08/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Operator ease and patient comfort during pre-oxygenation with high flow nasal cannula vs facemask in adult patients under general anaesthesia  
Scientific Title of Study   OPERATOR EASE AND PATIENT COMFORT DURING PRE-OXYGENATION WITH HIGH FLOW NASAL OXYGEN CANNULA VS FACEMASK 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 Abhijith Pradeep 
Designation  Post Graduate 
Affiliation  Maulana Azad Medical College 
Address  Department of Anaesthesiology BL Taneja Block Maulana Azad Medical college Bahadur Shah Zafar Marg New Delhi 110002

Central
DELHI
110002
India 
Phone  9496252327  
Fax    
Email  abhijithpradeep141@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mona Arya 
Designation  Professor 
Affiliation  Maulana Azad Medical College 
Address  Department of Anaesthesiology BL Taneja Block Maulana Azad Medical college Bahadur Shah Zafar Marg New Delhi 110002

Central
DELHI
110002
India 
Phone  9968604412  
Fax    
Email  monaarya@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Mona Arya 
Designation  Professor 
Affiliation  Maulana Azad Medical College 
Address  Department of Anaesthesiology BL Taneja Block Maulana Azad Medical college Bahadur Shah Zafar Marg New Delhi 110002


DELHI
110002
India 
Phone  9968604412  
Fax    
Email  monaarya@hotmail.com  
 
Source of Monetary or Material Support  
Maulana Azad Medical college and associated Lok Nayak Hospital,Bahadur Shah Zafar Marg,New Delhi-110002 
 
Primary Sponsor  
Name  Maulana Azad Medical College 
Address  Maulana Azad Medical college and associated Lok Nayak hospital, Bahadur Shah Zafar Marg 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 Abhijith Pradeep  Lok Nayak Hospital  Department of Anaesthesiology BL Taneja block Maulana Azad Medical College Bahadur shah zafar marg New Delhi
Central
DELHI 		 9496252327

abhijithpradeep141@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Patients posted for elective surgery under general anaesthesia 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Pre-oxygennation using facemasks  Patients posted for elective general anaesthesia surgeries were pre-oxygennated with 100% oxygen till ETO2 greater than 87% is attained. 
Intervention  Pre-oxygennation with HFNC(High flow nasal cannula)  Patients posted for elective general anaesthesia surgeries were pre-oxygennated with HFNC for 3 minutes 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients belonging to ASA physical status 1,2,3 
 
ExclusionCriteria 
Details  1)Patients undergoing caesarean section.
2)Any known contraindications to HFNO.
3)Patients on oxygen therapy.
4)Obese patients with BMI >35kg/m2
5)Awake intubation or with difficult airway.
6)Contraindications to CPAP.
7)Moderate to severe cardio-respiratory disease 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.Operator score during pre-oxygennation after securing the airway using 10cm visual analogue scale(VAS)
2)Patient comfort during pre-oxygennation assessed immediately before induction on a 5 point likert scale 		 5 minutes after securing a defenitive airway 
 
Secondary Outcome  
Outcome  TimePoints 
1)Mean end tidal O2 after securing a defenitive airway & after 5 minutes.
2)Number of patients with an episode of hypoxaemia.
3)End tidal CO2 after securing a defenitive airway 		 5 minutes after securing a defenitive airway 
 
Target Sample Size   Total Sample Size="208"
Sample Size from India="208" 
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)   15/08/2023 
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 - NO
Brief Summary   Pre-oxygennation is imperative to safety of airway management as it extends the time to hypoxemia after onset of apnea to allow adequate time for laryngoscopy ,intubation and initiation of mechanical ventilation.The safe apnea time provided by pre-oxygennation is dependant on the oxygen reservoir that is available to pulmonary circulation and can range from seconds to minutes ,depending on the patient characteristics.
                                              Patients between age 18-60 years posted for elective surgeries under general anesthesia are included in the study.They will be divided in to two groups which are facemask and HFNC groups.After routine pre-anaesthetic evaluation,patients will be taken up to the ot. All standard ASA monitors attached and baseline parameters noted.
In Facemask group,pre-oxygennation will be done using 100% oxygen until ETO2 is >87%.Patient induced with injection Fentanyl,Propofol and Vecuronium.Bag and mask ventilation done with 100% oxygen for 3 minutes and defenitive airway will be placed.
In HFNC group,patients will be pre-oxygennated with HFNC at 40L/mt  to maintain SPO2 >95% and for 3 minutres.Anaesthesia induced as facemask group and then the flow rate will be increased to 60 L/mt.Then airway will be secured.
In both groups once the airway is secured the ventilation with 100% oxygen will be continued for 5 minutes.Primary outcomes are the ease of the anaesthesiologist assessed using 10 cm visual analogue scale and patient comfort using 5  point Likert scale.
 
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