| CTRI Number |
CTRI/2021/09/036210 [Registered on: 03/09/2021] Trial Registered Prospectively |
| Last Modified On: |
28/08/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective observational study |
| Study Design |
Other |
|
Public Title of Study
|
STUDY TO COMPARE SF RATIO WITH PF RATIO IN CRITICALLY ILL PATIENTS ON RESPIRATORY SUPPORT IN INTENSIVE CARE UNIT |
|
Scientific Title of Study
|
A PROSPECTIVE OBSERVATIONAL STUDY TO COMPARE THE PULSE OXYMETRIC SATURATION(Spo2)/FRACTION OF INSPIRED OXYGEN(Fio2)(SF RATIO) AND PARTIAL PRESSURE OF OXYGEN(Pao2/Fio2(PF RATIO)AMONG CRITICALLY ILL PATIENTS REQUIRING RESPIRATORY SUPPORT IN INTENSIVE CARE UNIT |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shivakumar Iyer |
| Designation |
Prof and HOD Critical care Medicine |
| Affiliation |
Bharati vidyapeet deemed to be university |
| Address |
Department of Critical Care Medicine, Second floor, Bharati hospital, BVDU, Pune, Pune satara road, Maharashtra, 411043
Pune
MAHARASHTRA
411043
India |
| Phone |
9822051719 |
| Fax |
|
| Email |
suchetashiva@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shivakumar Iyer |
| Designation |
Prof and HOD Critical care Medicine |
| Affiliation |
Bharati vidyapeet deemed to be university |
| Address |
Department of Critical Care Medicine, Second floor, Bharati hospital, BVDU, Pune, Pune satara road, Maharashtra, 411043
Pune
MAHARASHTRA
411043
India |
| Phone |
9822051719 |
| Fax |
|
| Email |
suchetashiva@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rakesh Alur T |
| Designation |
D M critical care resident |
| Affiliation |
Bharati vidyapeet deemed to be university |
| Address |
Department of Critical Care Medicine, Second floor, Bharati hospital, BVDU, Pune, Pune satara road, Maharashtra, 411043
Pune
MAHARASHTRA
411043
India |
| Phone |
9822051719 |
| Fax |
|
| Email |
dr.rakeshcims@gmail.com |
|
|
Source of Monetary or Material Support
|
| BHARATI VIDYA PEETH MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE PUNE MAHARASHTRA 411043 |
|
|
Primary Sponsor
|
| Name |
BHARATI HOSPITAL |
| Address |
Department of Critical Care Medicine, Second floor, Bharati hospital, BVDU, Pune, Pune satara road, Maharashtra, 411043 |
| Type of Sponsor |
Private 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 Shivakumar Iyer |
Bharati hospital |
Department of Critical Care Medicine, 2nd floor, Intensive care units 1 and 2
Pune
MAHARASHTRA |
9822051719
suchetashiva@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J158||Pneumonia due to other specified bacteria, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All patients who needs oxygen support more than 18 years. |
|
| ExclusionCriteria |
| Details |
History of chronic lung disease, refractory shock, hypothermia, pregnant patients, carbon monoxide poisoning, methemoglobinaemia, hemoglobin less than 7 gm/dl |
|
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Method of Generating Random Sequence
|
|
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Method of Concealment
|
|
|
Blinding/Masking
|
|
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Primary Outcome
|
| Outcome |
TimePoints |
| To compare S/F ratio with P/F ratio |
At the time of admission when first arterial blood gas analysis done and second arterial blood gas analysis will be done if patient needing escalation of oxygen therapy or 24 hrs after admission. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine cut off value for s/f ratio in relation to p/f raion in ARDS |
one year |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
10/09/2021 |
| 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
|
Will publish once data collection and interpretation gets completed |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a prospective observational study conducted in a tertiary care teaching hospital in pune among the patients who require oxygen support with age morethan 18 years. The primary outcome is to compare SpO2/ FiO2 with Pao2/Fio2 ratio and secondary outcome is to determine relation ship of S/F ratio in case of ARDS. This will be useful study in remote places where there is no availability of ABG machines. If the results are significant it will be helpful for population in remote places for assessing the severity and further plan of care. |