| CTRI Number |
CTRI/2024/04/066029 [Registered on: 19/04/2024] Trial Registered Prospectively |
| Last Modified On: |
12/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Correlation of SpO2/FiO2 ratio with the PaO2/FiO2 ratio in patients with Acute Respiratory Distress Syndrome |
|
Scientific Title of Study
|
Correlation of Oxygen saturation/Fraction of inspired oxygen ratio with the Partial pressure of oxygen/Fraction of inspired oxygen ratio in patients with Acute Respiratory Distress Syndrome |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Hani |
| Designation |
Post Graduate resident |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care, Ground floor, Main OT building, Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar, New Delhi - 110029
South
DELHI
110029
India |
| Phone |
8178058149 |
| Fax |
|
| Email |
hanijhanjhar24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Arin Choudhury |
| Designation |
Associate Professor |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care, Ground floor, Main OT building, Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar, New Delhi - 110029
South
DELHI
110029
India |
| Phone |
7838756566 |
| Fax |
|
| Email |
arinchoudhury@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Arin Choudhury |
| Designation |
Associate Professor |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care, Ground floor, Main OT building, Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar, New Delhi - 110029
DELHI
110029
India |
| Phone |
7838756566 |
| Fax |
|
| Email |
arinchoudhury@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia and Intensive Care, Ground floor, Main OT building, 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 |
| Dr Hani |
Vardhman Mahavir Medical College and Safdarjung Hospital |
Department of Anaesthesia and Intensive Care, Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar, New Delhi - 110029
South
DELHI |
8178058149
hanijhanjhar24@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: J80||Acute respiratory distress syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients with ARDS with PaO2/FiO2 less than 200 with chest X-Ray demonstrating bilateral opacities. |
|
| ExclusionCriteria |
| Details |
Patients with hypotension with MAP less than 60 mmHg and weak peripheral pulses.
Patients with known congenital heart disease.
Patients with known haemoglobinopathies.
Patients with known peripheral vascular disease, extensive skin or soft tissue infections or burns making ABG sampling difficult. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Correlating the oxygen saturation/fraction of inspired oxygen ratio with the partial pressure of oxygen /fraction of inspired oxygen ratio in the patients with Acute Respiratory Distress Syndrome. |
On admission. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the mortality rate predicted by the oxygen saturation/fraction of inspired oxygen ratio and the partial pressure of oxygen /fraction of inspired oxygen ratio in patients with acute respiratory distress syndrome.
|
discharge/death |
|
|
Target Sample Size
|
Total Sample Size="77"
Sample Size from India="77"
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)
|
26/04/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 observational study to validate the relationship between SpO2/FiO2 and PaO2/FiO2 ratios in patients diagnosed with ARDS with the hypothesis that changes in SpO2 reliably predict equivalent changes in PaO2. This would help in establishing the threshold values for SpO2/FiO2 ratio that can serve as non-invasive criteria for diagnosing ARDS. Establishing such a correlation would be invaluable for predicting the clinical outcomes, determining optimal times for adjusting fractional inspired oxygen and/or repeating arterial blood gases in ARDS patients. |