| CTRI Number |
CTRI/2024/06/069000 [Registered on: 18/06/2024] Trial Registered Prospectively |
| Last Modified On: |
06/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Observational |
| Study Design |
Other |
|
Public Title of Study
|
Outcomes Of Non-Invasive Ventilation In Intensive Care Unit. |
|
Scientific Title of Study
|
Outcomes Of Non-invasive Ventilation On Patient With Respiratory Distress Admitted In Intensive Care Unit |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
D Sridhar |
| Designation |
Post Graduate Student |
| Affiliation |
Sri Ramachandra institute of higher education and research |
| Address |
Department Of Critical Care Medicine
M.SC Critical Care Technology
Sri Ramachandra Institute Of Higher Education And Research
Porur
Chennai-600116
Thiruvallur
TAMIL NADU
600116
India |
| Phone |
9790541893 |
| Fax |
|
| Email |
sridhartaker@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr MK Renuka |
| Designation |
Professor and Head of Department |
| Affiliation |
Sri Ramachandra institute of higher education and research |
| Address |
Professor and Head of Department
Department of Critical Care Medicine
Sri Ramachandra Institute Of Higher Education And Reserach
Porur
Chennai-600116
Thiruvallur
TAMIL NADU
6000116
India |
| Phone |
8056126336 |
| Fax |
|
| Email |
renuka.mk@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr MK Renuka |
| Designation |
Professor and Head of Department |
| Affiliation |
Sri Ramachandra institute of higher education and research |
| Address |
Professor and Head of Department
Department of Critical Care Medicine
Sri Ramachandra Institute Of Higher Education and Research
Porur
Chennai.
Thiruvallur
TAMIL NADU
6000116
India |
| Phone |
8056126336 |
| Fax |
|
| Email |
renuka.mk@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra Institute Of Higher Education and Research
Porur
Chennai-600116
Tamil Nadu
India |
|
|
Primary Sponsor
|
| Name |
Sri Ramachandra Institute Of Higher Education and Research |
| Address |
Department Of Critical Care Medicine
M.SC Critical Care Technology
Porur
Chennai-600116 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 MK Renuka |
Sri ramachandra institute of higher education and research |
Department Of Critical Care Medicine
Porur
Chennai-600116
Thiruvallur
TAMIL NADU |
8056126336
renuka.mk@sriramachandra.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Ramachandra Institute Of Higher Education And Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J00-J99||Diseases of the respiratory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All patient admitted in intensive care unit with respiratory distress.
All patient admitted in intensive care unit Patient above 18years. |
|
| ExclusionCriteria |
| Details |
Age group below 18 years. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Outcome of Patients in Non-invasive ventilation failure with Respiratory distress |
Six months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Outcomes of mortality in patients who failed on non-invasive ventilation |
Six months |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
15/07/2024 |
| 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="0"
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
|
Non-invasive ventilation (NIV) has emerged as an important tool for the management of respiratory distress in ICU. Depending on the response of the patients, monitoring, and various baseline parameters, further management needs to be decided so that intubation would not be delayed. The early introduction of non-invasive ventilation can reduce the rate of intubation and subsequent complications and infections associated with intubation. Respiratory failure is defined as a failure to sustain adequate gas exchange and is characterized by abnormalities of arterial blood gas Hence, in this study we are planning to observe the outcomes and to determine the factors associated with NIV failure in patients with respiratory distress. |