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CTRI Number  CTRI/2023/10/058996 [Registered on: 20/10/2023] Trial Registered Prospectively
Last Modified On: 15/10/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   A PROSPECTIVE COMPARATIVE OBSERVATIONAL STUDY. 
Study Design  Other 
Public Title of Study   To assess whether oxygenation through nasal tube (HFNO) is a better alternative for oxygen administration while you are made unconscious compared to face mask. 
Scientific Title of Study   A Comparison Of Efficacy Of Oxygenation Between High Flow Nasal Cannula And Standard Facemask For Preoxygenation And Endotracheal Intubation In Patients Undergoing 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 PATIL GAYATRI CHANDRAKANT 
Designation  JUNIOR RESIDENT 
Affiliation  KS HEGDE MEDICAL ACADEMY 
Address  KS Hegde Medical Academy, P. O. Nityanandanagar Deralakatte Mangluru, Karnataka 575018
Department of Anaesthesiology KS Hegde Medical Academy, P. O. Nityanandanagar Deralakatte Mangluru, Karnataka 575018
Dakshina Kannada
KARNATAKA
575018
India 
Phone  9423652603  
Fax    
Email  GAYATRI9919@GMAIL.COM  
 
Details of Contact Person
Scientific Query
 
Name  DR ANANDA BANGERA 
Designation  PROFESSOR 
Affiliation  KS HEGDE MEDICAL ACADEMY 
Address  Department of Anaesthesiology KS Hegde Medical Academy, P. O. Nityanandanagar Deralakatte Mangluru, Karnataka 575018
Department of Anaesthesiology KS Hegde Medical Academy, P. O. Nityanandanagar Deralakatte Mangluru, Karnataka 575018
Dakshina Kannada
KARNATAKA
575018
India 
Phone  9845278880  
Fax    
Email  ANANDA@NITTE.EDU.IN  
 
Details of Contact Person
Public Query
 
Name  DR ANANDA BANGERA 
Designation  PROFESSOR 
Affiliation  KS HEGDE MEDICAL ACADEMY 
Address  Department of Anaesthesiology KS Hegde Medical Academy, P. O. Nityanandanagar Deralakatte Mangluru, Karnataka 575018
Department of Anaesthesiology KS Hegde Medical Academy, P. O. Nityanandanagar Deralakatte Mangluru, Karnataka 575018
Dakshina Kannada
KARNATAKA
575018
India 
Phone  9845278880  
Fax    
Email  ANANDA@NITTE.EDU.IN  
 
Source of Monetary or Material Support  
Department of Anaesthesiology KS Hegde Medical Academy, P. O. Nityanandanagar Deralakatte Mangluru, Karnataka 575018 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
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 Gayatri Patil  KS Hegde Hospital  Department of Anaesthesiology KS Hegde Medical Academy, P. O. Nityanandanagar Deralakatte Mangluru, Karnataka 575018
Dakshina Kannada
KARNATAKA 
9423652603

GAYATRI9919@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 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  nil  nil 
Intervention  nil  nil 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA I, II
 
 
ExclusionCriteria 
Details  1.Patients’ or guardians’ refusal to participate
in the study
2.Patients with significant respiratory or cardiac
comorbidities
3.Pregnant ladies
4.Uncooperative patients
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate oxygenation with high flow nasal cannula & facemask oxygenation in terms of SpO2 & EtO2.  During & immediately after procedure for 5 min 
 
Secondary Outcome  
Outcome  TimePoints 
1.To assess efficacy of CO2 elimination in terms of EtCO2 level.
2.To find out the patients’ comfort level in accepting these two techniques for preoxygenation.
 
During & immediately after procedure 
 
Target Sample Size   Total Sample Size="102"
Sample Size from India="102" 
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)   23/10/2023 
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="6"
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  

This prospective observational comparative study will be conducted after obtaining approval from the Institutional Ethics Committee. A pre-anesthetic evaluation with a detailed medical history, systemic examination, and airway examination will be done and reviewed on the previous day and on the day of surgery.  Informed and written consent will be obtained from the patient and/or the patient’s guardian. Patient will be kept nil by mouth for 6 hours and premedicated according to standard institutional protocol. Once the patient is shifted to the operation theatre, standard preparations such as attaching routine monitoring devices like an electrocardiogram, pulse oximetry (SpO2), noninvasive blood pressure, and end tidal capnography will be done. Intravenous fluid will be started after securing a suitable intravenous cannula. Patients undergoing general endotracheal anesthesia with oxygenation under a face mask oxygenation will be included under group F and those with high-flow nasal oxygenation will be included under group H. The standard and common drugs for induction, muscle relaxation, and inhalational anesthesia will be followed for all the patients. In the HFNO group, oxygenation will be performed using a high-flow nasal cannula, with nasal prongs set at 30 L/min flow of heated and humidified 100% oxygen. In the FMO group, patients will breathe spontaneously with an appropriate-size standard facemask connected to a ventilation system with 100% oxygen at 8 L/min. If the patient doesn’t tolerate HFNO they will be motivated for the same and if they don’t cooperate even then will be oxygenated with regular facemask technique done as per the institutional protocol and will be excluded from the study. All of this will be after 3 minutes of oxygenation, the patient’s airway will be secured by the anesthesiologist in charge and the technique will be noted. Number of attempts, time for desaturation (SpO2 <92%), any events occurring during the process of intubation or any rescue methods if used in case of desaturation will be noted and the patient will be ventilated as per the institutional protocol. During intubation, the nasal prongs of the HFNO group will be left in place to achieve apnoeic oxygenation. In the FMO group, the facemask will be removed during intubation. The correct placement of the endotracheal tube will be confirmed by end-tidal capnography, and the nasal prongs will then be removed from the HFNO group. After intubation, maintenance of anesthesia will be done according to the standard institutional protocol.

 
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