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CTRI Number  CTRI/2023/06/054224 [Registered on: 21/06/2023] Trial Registered Prospectively
Last Modified On: 20/06/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   prospective comparative study 
Study Design  Other 
Public Title of Study   COMPARISON BETWEEN TWO METHODS OF OXYGEN CONCENTRATION MEASUREMENT DURING PREOXYGENATION BEFORE CRASH INDUCTION  
Scientific Title of Study   COMPARISON OF END TIDAL OXYGEN CONCENTRATION AND HAEMOGLOBIN SATURATION OF OXYGEN AS A MEASURE OF PREOXYGENATION PRIOR TO RAPID SEQUENCE INTUBATION 
Trial Acronym  not applicable 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Pooja Nagar 
Designation  Post Graduate resident 
Affiliation  Vardhman Mahavir Medical College and Safdarjung Hospital 
Address  Department of Anaesthesia and Intensive care, Vardhman Mahavir Medical College and Safdarjung hospital, Ansari Nagar, New Delhi

New Delhi
DELHI
110029
India 
Phone  9868242633  
Fax    
Email  Nagar0700@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Charu Bamba 
Designation  Consultant and Professor 
Affiliation  Vardhman Mahavir Medical College and Safdarjung Hospital 
Address  Department of Anaesthesia and Intensive care, Vardhman Mahavir Medical College and Safdarjung hospital, Ansari Nagar, New Delhi

New Delhi
DELHI
110029
India 
Phone  9811270511  
Fax    
Email  charu.bamba@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Pooja Nagar 
Designation  Post Graduate resident 
Affiliation  Vardhman Mahavir Medical College and Safdarjung Hospital 
Address  Department of Anaesthesia and Intensive care, Vardhman Mahavir Medical College and Safdarjung hospital, Ansari Nagar, New Delhi

New Delhi
DELHI
110029
India 
Phone  9868242633  
Fax    
Email  NAGAR0700@GMAIL.COM  
 
Source of Monetary or Material Support  
Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar, New Delhi 110029 
 
Primary Sponsor  
Name  Vardhman Mahavir Medical College and Safdarjung Hospital 
Address  Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar, New Delhi 110029 
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 
Pooja Nagar  Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi 110029  Department of anaesthesiology and intensive care , Ground floor , Main OT building, Vardhman Mahavir medical college and safdarjung Hospital, New Delhi 110029
New Delhi
DELHI 
9868242633

Nagar0700@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Vardhman Mahavir medical college and Safdarjung hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: Z00-Z99||Factors influencing health status and contact with health services,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  ASA I-III physical state undergoing rapid sequence intubation. 
 
ExclusionCriteria 
Details  1.Patients already on oxygen therapy
2.Anticipated difficult intubation

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
to compare end tidal oxygen concentration & hemoglobin saturation of oxygen at the end of preoxygenation.  at 0 mins & 3 mins 
 
Secondary Outcome  
Outcome  TimePoints 
to compare end tidal oxygen concentration & hemoglobin saturation of oxygen at the start of preoxygenation and at the end of intubation  at 0 mins & 3.45 mins 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   30/06/2023 
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  

. Difficult airway society suggests that when critically ill patients are intubated, preoxygenation should be performed until an End tidal oxygen level of greater than or equal to 85% is attained.

Effectiveness of preoxygenation can be assessed by values of oxygen saturation on pulse oximeter (SpO2 ) and End tidal oxygen [ETO2]. Although SpO2 is gold standard for assessing adequacy of preoxygenation as it is inexpensive and easily accessible. However it is an indirect measure of preoxygenation.

In earlier times ETO2 was not included for standard monitoring as it was expensive and not easily available. Therefore there was paucity of literature for assessing efficacy of preoxygenation using ETO2. With advancement of technology, availability of modern equipment, end tidal oxygen monitoring is feasible and should be considered as a monitoring standard for adequacy of preoxygenation . There is paucity of literature supporting the use of ETO2 as a guide for preoxygenation particularly in Indian hospital set up

Patient will be taken as per inclusion criteria. Preanesthetic evaluation of the patient. Written informed consent taken from patient. Patient taken to operation theatre, monitoring established, baseline vitals noted, monitoring of SpO2 and ETO2 concentration at the start of preoxygenation

Preoxygenation for 3 minutes with 100% oxygen

Monitoring of SpO2 and ETO2 concentration at the end of preoxygenation

Induction with Fentanyl, thiopentone or etomidate followed by suxamethonium 

Apnoeic oxygenation 100% oxygen for 45 seconds

Monitoring of SpO2 and ETO2 concentration at the end of intubation / beginning of capnographic waveform

n=70

Confirmation  of achieving effective ventilation


 
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