| CTRI Number |
CTRI/2025/08/093100 [Registered on: 14/08/2025] Trial Registered Prospectively |
| Last Modified On: |
12/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
we want to study about A Comparison of SpO2/FiO2(SF) Ratio Versus PaO2/FiO2(PF) Ratio among Acute Hypoxemic Respiratory Failure(AHRF) patients requiring Oxygen Supplementation in Intensive Care Unit
|
|
Scientific Title of Study
|
A Comparative Study of SpO2/FiO2(SF) Ratio Versus PaO2/FiO2(PF) Ratio among Acute Hypoxemic Respiratory Failure(AHRF) patients requiring Oxygen Supplementation in Intensive Care Unit at SMS Hospital, Jaipur
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nihar Sharma |
| Designation |
Professor |
| Affiliation |
SMS Medical college and hospitals |
| Address |
Department of Anaesthesiology Intensive Care Unit SMS Medical College and Hospitals Jaipur RAJASTHAN
Jaipur
RAJASTHAN
302004
India |
| Phone |
9314044376 |
| Fax |
|
| Email |
drniharsharma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nihar Sharma |
| Designation |
Professor |
| Affiliation |
SMS Medical college and hospitals |
| Address |
Department of Anaesthesiology Intensive Care Unit SMS Medical College and Hospitals Jaipur RAJASTHAN
Jaipur
RAJASTHAN
302004
India |
| Phone |
9314044376 |
| Fax |
|
| Email |
drniharsharma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rahul Saini |
| Designation |
Resident Doctor |
| Affiliation |
SMS Medical College and Hospitals |
| Address |
Department of Anaesthesiology Intensive Care Unit SMS Medical College and Hospitals Jaipur RAJASTHAN
Jaipur
RAJASTHAN
302004
India |
| Phone |
8619563497 |
| Fax |
|
| Email |
rhsaini687@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesia SMS Medical College and Hospital Jaipur Rajasthan INDIA 302004 |
|
|
Primary Sponsor
|
| Name |
SMS Medical college and hospitals |
| Address |
Department of Anaesthesiology Intensive Care Unit SMS Medical College and Hospitals Jaipur RAJASTHAN 302004 |
| 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 Nihar Sharma |
SMS MEDICAL COLLEGE AND HOSPITAL |
ICU SMS Medical College and Hospitals Jaipur Rajasthan
Jaipur
RAJASTHAN |
9314044376
drniharsharma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMS Medical College and Attached Hospitals JAIPUR |
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 |
PaO2/FiO2 (PF) |
requirement of oxygen supplementation among hypoxemic respiratory failure in ICU |
| Intervention |
SpO2/FiO2(SF) |
requirement of oxygen supplementation among acute hypoxemic respiratory failure in ICU |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with confirmed diagnosis of acute hypoxemic respiratory failure (AHRF) admitted to the intensive care unit (ICU) for requirement of O2 Supplementation by various modalities.
2.Patients giving written informed consent.
3.Patients more than 18 years of age.
|
|
| ExclusionCriteria |
| Details |
1.Chronic Lung Disease.
2. Requirement for more than one vasopressor to maintain blood pressure and perfusion.
3. Severe Hypothermia
4. Severe Anaemia
5. Specific Poisonings: Carbon monoxide poisoning, Methemoglobinemia.
6. Pregnant Women
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To determine the correlation between the SpO2/FiO2(SF) ratio and the PaO2/FiO2(PF) ratio in AHRF patients requiring O2 supplementation in ICU.
|
1.Parameters Reassessed During Deterioration or Within 24 Hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To assess the diagnostic utility of the SpO2/FiO2(SF) ratio in identifying the severity of Acute Hypoxemic Respiratory Failure in Resource Limited Settings.
2. To assess the applicability and reliability of the SpO2/FiO2(SF) ratio in diagnosis of Acute Hypoxemic Respiratory Failure in Resource Limited Settings.
3. To assess the influence of various O2 Modes on SpO2/FiO2(SF) Ratio correlation between SpO2/FiO2 (SF) & PaO2/FiO2(PF) Ratio.
4. To assess the impact of acid-base status on correlation between SpO2/FiO2(SF) & PaO2/FiO2(PF) Ratio.
|
Parameters Reassessed During Deterioration or Within 24 Hours |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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)
|
08/09/2025 |
| 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="0"
Months="2"
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
|
In this study we discuss the comparison of SpO2/FiO2 ratio Versus PaO2/FiO2 among acute Hypoxemic Respiratory Failure patient requiring oxygen supplementation |