| CTRI Number |
CTRI/2024/07/070368 [Registered on: 10/07/2024] Trial Registered Prospectively |
| Last Modified On: |
10/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
PROSPECTIVE OSERVTIONAL STUDY |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study of sub types in patients with Hypoxic respiratory failure |
|
Scientific Title of Study
|
A Prospective Observtional Study Of Subphenotypes In Patients Presenting With Hypoxic Respiratory Failure |
| 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. GANSHYAM JAGATKAR |
| Designation |
DIRECTOR AND HEAD OF THE DEPARTMENT |
| Affiliation |
MEDICOVER HOSPITALS, HITECH CITY, HYDERABAD |
| Address |
3 RD FLOOR
DEPARTMENT OF CRITICAL CARE MEDICINE
MEDICAL ICU 1
MEDICOVER HOSPITALS
HITECH CITY
HYDERABAD
Hyderabad
TELANGANA
500081
India |
| Phone |
9949001344 |
| Fax |
|
| Email |
drganshyam@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR. GANSHYAM JAGATKAR |
| Designation |
DIRECTOR AND HEAD OF THE DEPARTMENT |
| Affiliation |
MEDICOVER HOSPITALS, HITECH CITY, HYDERABAD |
| Address |
3 RD FLOOR
DEPARTMENT OF CRITICAL CARE MEDICINE
MEDICAL ICU 1
MEDICOVER HOSPITALS
HITECH CITY
Hyderabad
TELANGANA
500081
India |
| Phone |
9949001344 |
| Fax |
|
| Email |
drganshyam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR JYOTHSNA YADAV |
| Designation |
RESIDENT |
| Affiliation |
MEDICOVER HOSPITALS, HITECH CITY, HYDERABAD |
| Address |
3 RD FLOOR
DEPARTMENT OF CRITICAL CARE MEDICINE
MEDICAL ICU 1
MEDICOVER HOSPITALS
HITECH CITY HYDERABAD
Hyderabad
TELANGANA
500081
India |
| Phone |
9849203745 |
| Fax |
|
| Email |
jyothsnayadav7@gmail.com |
|
|
Source of Monetary or Material Support
|
| Medicover Hospitals,Hitech city,Hyderabad,Telangana, India,500081. |
|
|
Primary Sponsor
|
| Name |
Dr Jyothsna Yadav C |
| Address |
Medical ICU, Department of Critical Care Medicine,
3 rd floor, Medicover Hospitals, Hitech city, Hyderabad. 500081 |
| Type of Sponsor |
Other [Self] |
|
|
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 Jyothsna |
Medicover Hospitals |
3 rd floor, Department of Critical Care Medicine, Medicover Hospitals, Hitech city, Hyderabad- 500081
Hyderabad
TELANGANA |
9849203745
jyothsnayadav7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| InstitutionalEthicsCommitteMedicoverHospitals |
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 |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with Hypoxic respiratory failure
2. P/F Ratios <250 |
|
| ExclusionCriteria |
| Details |
1. Age less than 18 years
2. Age more than 60 years
3. Pregnancy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary outcome is to identify phenotypes in patients coming with hypoxic respiratory failure. |
This study will be done over a duration of 18 months.
Inflammatory biomarkers IL6 and CRP will be sent for all patients on Day 1, Day 3 and on the day of liberation from ventilation. Oxygen index, P/F ratios, Driving pressures, Change in compliance, Mechanical power will be calculated on Day 1, Day 3 and on the day of liberation from mechanical ventilation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
22/07/2024 |
| 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="6"
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
|
Hypoxic respiratory failure is associated with high morbidity and mortality . Heterogenecity challenges the identification of effective therapies.Aim of my study is to charecterize subphenotypes/ subtypes in a braoder hypoxic respiratory failure patients. Previous efforts to identify subphenotypes of respiratory failure have largely centred on Acute respiratory distress syndrome. My objective is to compare circulating biomarkers previously linked to severity and outcomes in lung injury. In particular we will be charecterizing the clinical and biological features of patients with acute hypoxic respiratory failure. |