| CTRI Number |
CTRI/2025/11/097048 [Registered on: 07/11/2025] Trial Registered Prospectively |
| Last Modified On: |
04/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study on how different sedation medicines affect recovery and outcomes in patients on ventilators in the Intensive Care Unit. |
|
Scientific Title of Study
|
An observational study on the choice of sedation and clinical outcomes in
mechanically ventilated patients in the Intensive Care Units of a tertiary care hospital |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shivakumar Sindhur |
| Designation |
NPCC Student |
| Affiliation |
Manipal College of Nursing, Manipal |
| Address |
Manipal College of Nursing, Manipal, Madhav Nagar, Manipal Academy of Higher Education
Manipal College of Nursing
Udupi
KARNATAKA
576104
India |
| Phone |
6363681709 |
| Fax |
|
| Email |
shivakumar.mconmpl2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Shivakumar Sindhur |
| Designation |
NPCC Student |
| Affiliation |
Manipal College of Nursing, Manipal |
| Address |
4th floor, Manipal College of Nursing, Manipal, Madhav Nagar, Manipal Academy of Higher Education
Manipal College of Nursing
Udupi
KARNATAKA
576104
India |
| Phone |
6363681709 |
| Fax |
|
| Email |
shivakumar.mconmpl2024@learner.manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prima JJ DSouza |
| Designation |
Assistant Professor |
| Affiliation |
Manipal College Of Nursing, Manipal |
| Address |
Manipal College Of Nursing, Manipal
Manipal College Of Nursing, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9986244210 |
| Fax |
|
| Email |
prima.jj@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Critical care Medicine first flour ICU 1 and ICU 2 Kasturba Hospital Manipal Udupi |
|
|
Primary Sponsor
|
| Name |
Shivakumar sindhur |
| Address |
4th flour 400B manipal college of nursing madhav nagar manipal academy of higher education manipal |
| Type of Sponsor |
Other [Self funded] |
|
|
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 Vishal Shanbhag |
ICU-1 AND ICU-2 first flour kasturba hospital |
kasturba hospital manipal critical care medicine department ICU 1 and ICU 2 first flour manipal
Udupi
KARNATAKA |
9901960496
vishal.shanbhag@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba medical college and kasturba hospital institutional ethics comitte-2(student 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 |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients aged above 18 years
2 Patients who are mechanically ventilated with invasive ventilation within 48 hours of ICU
admission
3 Patients who are receiving sedation and analgesia
4 Patient’s primary relatives are willing to consent to the study |
|
| ExclusionCriteria |
| Details |
1 Patients diagnosed brain dead
2 Patients who are receiving palliative care
3 Patients admitted with head injury and neurological condition(stroke)
4 Patients who are on Mechanical ventilation for less than 48 hours post-surgery
5 Cardiac arrest (code blue) patient |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Duration of Mechanical Ventilation, length of ICU and hospital stay, 28-day
mortality, and ICU events (hypotension, delirium, ventilator-associated pneumonia, hospital-associated
pressure injury, CLABSI, CAUTI, Bacteremia, dialysis). |
Duration of Mechanical Ventilation, length of ICU and hospital stay, 28-day
mortality, and ICU events (hypotension, delirium, ventilator-associated pneumonia, hospital-associated
pressure injury, CLABSI, CAUTI, Bacteremia, dialysis). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NILL |
NILL |
|
|
Target Sample Size
|
Total Sample Size="323"
Sample Size from India="323"
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)
|
02/11/2027 |
| 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
|
The purpose of this study is to observe the choice
of sedation among mechanically ventilated patients in ICUs and evaluate the association with clinical
outcomes. The study aims to provide insights into sedation practices and optimize patient care in critical
care settings. Hypothesis of the study: There will be a significant association between the choice of sedation and clinical outcomes in
mechanically ventilated patients in ICUs. |