| CTRI Number |
CTRI/2024/09/074180 [Registered on: 23/09/2024] Trial Registered Prospectively |
| Last Modified On: |
18/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
The Underlying Causes and Outcomes of Patients on Invasive Mechanichal Ventilator |
|
Scientific Title of Study
|
A Study of Cases on Invasive Mechanical Ventilator:Exploring Etiology and Course |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pradip Chaudhari |
| Designation |
Junior Resident |
| Affiliation |
Dr DY Patil Medical College and Hospital,Navi Mumbai |
| Address |
Department of General Medicine Dr DY Patil Medical Collage and Hospital ,Navi Mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
8849298873 |
| Fax |
|
| Email |
chaudharipradip00@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Santwana Chandrakar |
| Designation |
Professor |
| Affiliation |
Dr DY Patil Medical College and Hospital,Navi Mumbai |
| Address |
Department of General Medicine Dr DY Patil Medical Collage and Hospital ,Navi Mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
9820505489 |
| Fax |
|
| Email |
santwana.chandrakar@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pradip Chaudhari |
| Designation |
Junior Resident |
| Affiliation |
Dr DY Patil Medical College and Hospital,Navi Mumbai |
| Address |
Department of General Medicine Dr DY Patil Medical Collage and Hospital ,Navi Mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
8849298873 |
| Fax |
|
| Email |
chaudharipradip00@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr DY Patil Medical College and Hospital,Navi Mumbai
Pincode 400706
Maharashtra
India |
|
|
Primary Sponsor
|
| Name |
Pradip Chaudhari |
| Address |
Department of General Medicine Dr DY Patil Medical College and Hospital,Navi Mumbai |
| Type of Sponsor |
Other [Primary invesigator] |
|
|
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 Pradip chaudhari |
Dr DY Patil Medical College and Hospital,Navi Mumbai |
Medical ICU No-1 and Medical ICU No-2
2nd floor
General Medicine department
Dy Patil hospital
Dr DY Patil Medical College and Hospital,Navi Mumbai
Thane
MAHARASHTRA |
8849298873
chaudharipradip00@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee for Biomedical and Health research(IECBH) of D Y Patil Medical College & Hospital Navi Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J962||Acute and chronic respiratory failure, (2) ICD-10 Condition: I639||Cerebral infarction, unspecified, (3) ICD-10 Condition: K709||Alcoholic liver disease, unspecified, (4) ICD-10 Condition: M048||Other autoinflammatory syndromes, (5) ICD-10 Condition: B978||Other viral agents as the cause ofdiseases classified elsewhere, (6) ICD-10 Condition: I26||Pulmonary embolism, (7) ICD-10 Condition: T36-T50||Poisoning by, adverse effect of and underdosing of drugs, medicaments and biological substances, (8) ICD-10 Condition: I20-I25||Ischemic heart diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1)To classify based on their etiology to determine the need for invasive mechanical ventilation
2)To study clinical course of patients during invasive mechanical ventilation
3)To study various complications and infection in patients on invasive mechanical ventilation
4)To study outcome of patients on invasive mechanical ventilation |
|
| ExclusionCriteria |
| Details |
1) pregnant
2) Cases already taken treatment outside and intubated in the hospital where patient was admitted previously |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Survived /died |
From patient got intubated to patient got shifted from icu to less intensive care or demise of patient in icu |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Shifting of patients with tracheostomy from icu to less intensive care unit |
When patient shift out from icu |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
29/09/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This study investigates cases involving invasive mechanical ventilation, with a focus on understanding the underlying causes (etiology) and the progression (course) of conditions requiring such intervention. It systematically analyzes patient data to identify common etiological factors leading to the need for invasive ventilation and examines the clinical trajectories of these patients over time. The findings aim to provide insights into the predictors of outcomes and inform clinical practices related to the management of patients on invasive mechanical ventilation.
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