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
|
|
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
|
|
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 |