| CTRI Number |
CTRI/2025/07/091023 [Registered on: 16/07/2025] Trial Registered Prospectively |
| Last Modified On: |
08/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Observation of the sedation practices in the crtically ill patients and development of sedation protocol based on intial obseravtion and expert recommendations |
|
Scientific Title of Study
|
Development of a Sedation Protocol for Mechanically Ventilated Patients: A Mixed-Methods Study |
| 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 Sagar M S |
| Designation |
Additional Professor |
| Affiliation |
Kasturba Medical College, Manipal Academy of Higher Education |
| Address |
Dept of critical care, Kasturba Medial College Manipal
Udupi KARNATAKA 576104 India |
| Phone |
9764391100 |
| Fax |
|
| Email |
sagar.ms@manipal.edu |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sagar M S |
| Designation |
Additional Professor |
| Affiliation |
Kasturba Medical College, Manipal Academy of Higher Education |
| Address |
Dept of critical care, Kasturba Medial College Manipal
Udupi KARNATAKA 576104 India |
| Phone |
9764391100 |
| Fax |
|
| Email |
sagar.ms@manipal.edu |
|
Details of Contact Person Public Query
|
| Name |
Dr Sagar M S |
| Designation |
Additional Professor |
| Affiliation |
Kasturba Medical College, Manipal Academy of Higher Education |
| Address |
Dept of critical care, Kasturba Medial College Manipal
Udupi KARNATAKA 576104 India |
| Phone |
9764391100 |
| Fax |
|
| Email |
sagar.ms@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College and hospital, Manipal, Madhav Nagar, Manipal, Karnataka , Pin 576104 |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College, MAHE,Manipal, Karnataka |
| Address |
Kasturba Medical College, MAHE, Manipal, 576104, Udupi District, Karnataka |
| 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 Sagar M S |
Kasturba hospital and Kasturba Medical College , Manipal, Karnatak |
Department of critical care, Intensive care unit number 1 and 2, first floor, new trauma block Udupi KARNATAKA |
09764391100
sagar.ms@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Implementation of a standardized, validated sedation protocol |
This pilot trial evaluates a non-drug interventional sedation protocol using approved sedatives; hence the trial phase is marked as Not Applicable.
The intervention involves implementing a standardized sedation protocol for adult ICU patients on mechanical ventilation. This protocol includes the use of sedation assessment tools such as the Richmond Agitation-Sedation Scale (RASS) and Sedation-Agitation Scale (SAS), protocol-based titration of commonly used sedatives (Midazolam, Propofol, Dexmedetomidine, and Fentanyl), and non-pharmacologic measures such as daily sedation interruption, nurse-led assessments, and individualized sedation targets. The goal of the intervention is to optimize sedation depth, enhance patient comfort, minimize sedation-related complications, and support timely ventilator weaning. |
| Comparator Agent |
Traditional Sedation practices |
In this single-arm pilot interventional study. The outcomes will be compared to baseline practices and historical data collected prior to protocol implementation.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patient more than 18 year requiring mechanical ventilation |
|
| ExclusionCriteria |
| Details |
patient with traumatics brain injury, stroke, neurodegenrative disorders |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Feasiblity and adherence to sedation protocol |
30 days follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence of delirium, ICU length of stay,Mortality rate and Feedback from staff |
30 days follow up |
|
|
Target Sample Size
|
Total Sample Size="237" Sample Size from India="237"
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)
|
01/08/2025 |
| 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="3" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 prospective study will be conducted in three phases following ethical approval and informed consent from patients or their legal guardians. Phase 1 is a quantitative observational study to document current sedation practices in ICU patients, including types and doses of sedatives, frequency and methods of sedation assessment, target sedation levels, and inter-provider variability. Phase 2 includes two components. Phase 2a is a qualitative study using semi-structured interviews and focus group discussions to explore barriers and facilitators to sedation protocol adherence among ICU staff. Phase 2b involves the development of a structured sedation protocol using the modified Delphi method with input from a multidisciplinary expert panel. The protocol will undergo content validation by clinicians, nurses, and psychologists to ensure clarity, relevance, and feasibility. Phase 3 is a single-arm feasibility study to implement the validated sedation protocol in the ICU. The protocol includes RASS-based sedation targets, 4-hourly RASS assessments, twice-daily CAM-ICU delirium checks, standardized sedative titration, daily sedation interruption when appropriate, and a sedation checklist during rounds. ICU staff will receive prior training. Outcomes assessed will include protocol adherence, usability, safety, and staff feedback. Adverse events monitored will include hypotension, bradycardia, respiratory depression, over- or under-sedation, agitation, delirium, and drug-specific complications. Criteria for withdrawal include serious adverse effects or protocol non-compliance. Data collection will include baseline demographic and clinical data, serial RASS assessments every 4 to 6 hours, CAM-ICU assessments twice daily, and follow-up until ICU discharge, including a 7-day post-discharge phone follow-up for delayed adverse effects. The study may be terminated early if significant safety concerns arise. This pilot trial evaluates a non-drug interventional sedation protocol using approved sedatives; hence the trial phase is marked as Not Applicable. This phased approach aims to develop and validate a practical, safe, and effective sedation protocol for ICU patients on mechanical ventilation. |