| CTRI Number |
CTRI/2025/03/083672 [Registered on: 28/03/2025] Trial Registered Prospectively |
| Last Modified On: |
26/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
A Study on the Relationship Between Oxygen Levels in the Blood and Breathing Settings in ICU Patients Using Different Ventilation Methods. |
|
Scientific Title of Study
|
A prospective observational study on the correlation between SPO2 FiO2(SF) ratio and PaO2 FiO2(PF)ratio in different modes of ventilation in ICU patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
S Ashwini |
| Designation |
PG Student |
| Affiliation |
SRM Medical College Hospital and Research Centre |
| Address |
NO 22 4th floor department of Critical care medicine SRM hospital
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
09952186987 |
| Fax |
|
| Email |
ashsakthi09@gmail com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr CK Swetha ramani |
| Designation |
Professor |
| Affiliation |
SRM Medical College Hospital and Research Centre |
| Address |
No 15 2nd floor department of anesthesiology SRM hospital
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9944567803 |
| Fax |
|
| Email |
swethark@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr CK Swetha ramani |
| Designation |
Professor |
| Affiliation |
SRM Medical College Hospital and Research Centre |
| Address |
No 15 2nd floor department of anesthesiology SRM hospital
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
09944567803 |
| Fax |
|
| Email |
swethark@srmist.edu.in |
|
|
Source of Monetary or Material Support
|
| SRM Medical college hospital and research centre SRM nagar potheri chengalpattu 603203 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
nil |
| Type of Sponsor |
Other [NIL] |
|
|
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 C K Swetha ramani |
SRM Medical College Hospital and Research Centre |
No 15 2nd floor department of anesthesiology
Kancheepuram
TAMIL NADU |
9884782554
swethark@srmist.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM Medical College Hospital and Research Centre Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J960||Acute respiratory failure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All adult patients aged 18 to 60 years admitted in ICU with respiratory failure and oxygen supplementation. |
|
| ExclusionCriteria |
| Details |
Unreliable pulse oximetry waveform
Patients in sever shock with clod clammy peripheries
Patient who are at hypothermia
Patient with sever congenital heart disease or ejection fraction less than 50 percentage or congestive heart failure |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine SpO2/FiO2(SF) ratio and PaO2/FiO2(PF) ratio in different modes of ventilation |
Day one after ICU admission |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To identify the relationship between SpO2/FiO2(SF) ratio and PaO2/FiO2(PF) ratio |
Day one after ICU admission |
|
|
Target Sample Size
|
Total Sample Size="154"
Sample Size from India="154"
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)
|
20/04/2025 |
| 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="3"
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
|
Patient’s with acute respiratory failure admitted to intensive care unit will be enrolled in this prospective observational study. Variables such as, fraction of inspired oxygen (FiO2), partial pressure of arterial oxygen (PaO2), oxygen saturation(SpO2) and perfusion index will be noted from arterial blood gas reports and nurse’s chart respectively. Other vital signs includes SBP, DBP, MAP will also be noted. The calculated SF and PF ratios are recorded, and the correlation between SF and PF is noted in different methods of oxygen administration. |