| CTRI Number |
CTRI/2024/07/070936 [Registered on: 22/07/2024] Trial Registered Prospectively |
| Last Modified On: |
19/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Oxygen reserve index is the important tool to determine early desaturation |
|
Scientific Title of Study
|
Usefullness of oxygen reserve index as an early warning for desaturation during rapid sequence induction : a cross sectional study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
B Mahalakshmi |
| Designation |
Post graduate in MD anaesthesiology |
| Affiliation |
Karnataka institute of medical sciences |
| Address |
Department of anesthesiology, Karnataka institute of medical sciences, Hubli
Dharwad
KARNATAKA
580022
India |
| Phone |
8151809267 |
| Fax |
|
| Email |
mahalakshmi7614@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Madhuri S Kurdi |
| Designation |
Professor and Head of Department |
| Affiliation |
Karnataka institute of medical sciences |
| Address |
Department of anesthesiology, Karnataka institute of medical sciences, Hubli
Dharwad
KARNATAKA
580022
India |
| Phone |
9449590556 |
| Fax |
|
| Email |
drmadhuri_kurdi@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr MadhuriS Kurdi |
| Designation |
Professor and head of Department |
| Affiliation |
Karnataka institute of medical sciences |
| Address |
Department of anesthesiology, Karnataka institute of medical sciences, Hubli
Dharwad
KARNATAKA
580022
India |
| Phone |
9449590556 |
| Fax |
|
| Email |
drmadhuri_kurdi@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Karnataka institute of medical sciences Hubballi,Hubballi- 580022, Dharwad, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Karnataka institute of medical sciences |
| Address |
Department of anesthesiology, Karnataka institute of medical sciences, Hubli -580022, Karnataka, India |
| 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 |
| Dr B Mahalakshmi |
Karnataka institute of medical sciences |
Department of anesthesiology , Karnataka institute of medical sciences, PB road Vidyanagar hubballi- 580022
Dharwad
KARNATAKA |
8151809267
mahalakshmi7614@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Karnataka institute of medical sciences, Hubballi ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patient belonging to ASA physical status 1,2 and 3 giving informed, valid and written consent , undergoing lecture and emergency surgery under general anaesthesia |
|
| ExclusionCriteria |
| Details |
Those with known or anticipated difficult intubation. Those with significant respiratory comorbidities like pleural effusion,pulmonary edema, restrictive and obstructive lung diseases, pneumonia. Pregnant females |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Oxygen reserve index detects impending desaturation before noticeable changes in SpO2 occur |
Baseline
At the end of preoxygenation
At start of intubation
When SpO2 will be 94%
During ventilation using breathing circuit with 100% Fio2 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find out utility of oxygen reserve index as a guide to preoxygenation for avoiding hyperoxia |
Baseline
At the end of preoxygenation |
|
|
Target Sample Size
|
Total Sample Size="97"
Sample Size from India="97"
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)
|
30/07/2024 |
| 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="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
|
Prolonged hypoxemia can produce tissue injury and serious peri operative complications including dysrhythmias, brain injury or death. Prior to utilisation of pulse oximetry , hypoxemia was the leading cause of anaesthesia associated peri operative mortality worldwide.Assessment of patient’s oxygenation to detect desaturation early facilitates intervention that prevent complication of prolonged hypoxemia. Arterial blood gas provides a definitive measurement of oxygenation status but is limited by its intermittent and invasive nature Pulse oximetry is non invasive and provides efficient monitoring , so it is often used in lieu of ABG analysis . Pulse oximetry oxygen saturation is determined by measuring the absorption of two emitted light wavelengths and calculating the proportion of oxyhemoglobin to deoxyhemoglobin. The SPO2 to PaO2 relationship is linear at lower PaO2 , but plateaus quickly at PaO2 >80mmhg, above which SpO2 will be 98-100% regardless PaO2 , consequently providing limited information regarding a patient’s PaO2 in the hyperoxic range. Conversely ,SpO2 decreases rapidly as PaO2 falls below 80mmhg and can fail to provide early detection of impending critical hypoxemia . An infrared transmission pulse oximetry technology that utilises >_ 7 additional wavelengths of light transmission can determine a value called the oxygen reserve index. Oxygen reserve index is reported on a unit less scale from 0 ( minimal reserve ) to 1 (high reserve) and correlates to PaO2 values in the mildly hyperoxic range between approximately 100 and 200mmhg. Oxygen reserve index is not a direct measure of PaO2 and there is wide variation in supra normal PaO2 values after oxygen reserve index values plateau. Oxygen reserve index has been shown to provide a clinically useful advanced warning of arterial haemoglobin desaturation in paediatric patients, during one lung ventilation, and during rapid sequence induction. The ability of oxygen reserve index to detect changes in arterial oxygenation within the mildly hyperoxic range could provide additional time to respond .
Aim: to find out the utility of oxygen reserve index in the early detection of impending desaturation and prevention of hyperoxia during preoxygenation.
Objective: Primary objective:to find out whether oxygen reserve index detects impending desaturation before noticeable changes in SpO2 occurs
Secondary objective: to find out the utility of oxygen reserve index as a guide to preoxygenation for avoiding hyperoxia
Materials and method: cross sectional study Sample size:97 |