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CTRI Number  CTRI/2024/10/074738 [Registered on: 04/10/2024] Trial Registered Prospectively
Last Modified On: 25/09/2024
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 oxygen given via High flow nasal oxygen or Face Mask for Prolongation of Time when patient is not breathing in Obese Patients Undergoing Elective Surgery under General Anaesthesia. 
Scientific Title of Study   Comparison of High Flow Nasal Oxygenation and Face Mask Oxygenation for Prolongation of Safe Apnoea Time in Obese Patients Undergoing Elective Surgery 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  Falak Faizan 
Designation  Post graduate student  
Affiliation  ABVIMS and RML Hospital  
Address  Department of Anaesthesia ABVIMS and Dr RML Hospital

New Delhi
DELHI
110001
India 
Phone  8448236882  
Fax    
Email  faizanfalak1109@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Nisha Kachru 
Designation  Professor  
Affiliation  ABVIMS and Dr RML Hospital  
Address  Department of Anaesthesia ABVIMS and Dr. RML Hospital

New Delhi
DELHI
110001
India 
Phone  9810488435  
Fax    
Email  nishakachru@yahoo.co.uk  
 
Details of Contact Person
Public Query  
Name  Nisha Kachru 
Designation  Professor  
Affiliation  ABVIMS and Dr RML Hospital  
Address  Department of Anaesthesia ABVIMS and Dr. RML Hospital

New Delhi
DELHI
110001
India 
Phone  9810488435  
Fax    
Email  nishakachru@yahoo.co.uk  
 
Source of Monetary or Material Support  
ABVIMS AND DR RML HOSPITAL  
 
Primary Sponsor  
Name  ABVIMS and Dr Ram Manohar Lohia Hospital  
Address  Baba Kharak Singh Marg New Delhi 110001  
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 
Falak Faizan   Atal Bihari Institute of Medical Sciences And Dr. Ram Manohar Lohia Hospital  Department of Anaesthesia, PGI Building,Delhi 110001 New Delhi DELHI
New Delhi
DELHI 		 8448236882

faizanfalak1109@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The Institutional Ethics Committee, ABVIMS , Dr. RML Hospital, New Delhi  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  Preoxygenation with facemask.   Group B patients will recieve preoxygenation with tightly held face mask at 10L per minute with 100 percent Oxygen with CPAP of 5 cm of H2O. We will calculate the safe apnoea time i.e, SPO2 equals or below 94 percent or apnoea time more than ot equal to 6 minutes. 
Intervention  Preoxygenation with High flow nasal oxygenation.  Group A patients will recieve preoxygenation with High flow nasal oxygenation at 40L per min for 1 minute and 70L per min for next 2 minutes. We will calculate the safe apnoea time i.e, SPO2 equals or below 94 percent or apnoea time more than or equal to 6 minutes. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Body mass index (BMI) ≥30 kg/m2.
2. ASA II  
 
ExclusionCriteria 
Details  1. Patients with risk factors for difficult airway (indication for flexible optic intubation, high risk of regurgitation or expected difficult mask ventilation).
2. Uncontrolled gastric reflux disease.
3. Inability to breathe through nose due to nasopharyngeal obstruction or compulsive mouth breather.
4. Pregnant patients.
5. Known case of any systemic disorder such as cardiac, respiratory, renal or hepatic.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Number of patients in each group in whom apnoea time is less than 6 minutes.
2. In these patients, time taken for SPO2 to reach 94% after induction of anaesthesia. 		 Every 1 minute for 6 minutes 
 
Secondary Outcome  
Outcome  TimePoints 
1) Maximum EtCO2 reached after start of ventilation.
2) Arterial blood gas analysis will be done at the following intervals. Baseline on room air , at the end of preoxygenation which is also start of apnoea time, and at the end of apnoea time.
3) Hemodynamic changes - baseline and every 2 minutes from the start of preoxygenation till intubation is completed.
4) patient’s comfort level as comfortable, neutral or uncomfortable.  		 1) Baseline, start of preoxygenation, end of preoxygenation.
2) Baseline, every 2 minutes till intubation.
 
 
Target Sample Size   Total Sample Size="62"
Sample Size from India="62" 
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)   06/10/2024 
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="1"
Days="1" 
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 is an interventional parallel group study design to compare high flow nasal oxygenation and face mask oxygenation for prolongation of safe apnoea time in obese patients undergoing elective surgery under general anaesthesia ,since there is a paucity of studies  in the Indian population  for the same.The primary  objective is to compare high flow nasal oxygenation  and face mask oxygenation for prolongation of safe apnoea time in obese patients undergoing elective surgery. The secondary objective are to compare  ventilation  and assess change in hemodynamic parameters and compare patient comfort between the two techniques. Patients will be allocated  in two groups ,with 31 patients in each group . Group A patients will receive preoxygenation with High Flow Nasal Oxygenation at 40L/minute for 1 minute  and 70L/minute  for 2 minutes ; Group B patients  will recieve preoxygenation with 100% oxygen through tightly held face mask at 10L/minute with CPAP of 5 cm of H2O. The primary outcome measures are number  of patients  in each group in whom apnoea time is less than 6 minutes and time taken  for spo2 to reach 94% .The secondary outcome measures are maximum etco2 reached after start of ventilation, arterial blood gas analysis at baseline,at the end of preoxygenation  and at the end of apnoea time, hemodynamic changes and patients comfort level.The data will be collected ,analysed and statistically evaluated  . 
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