| CTRI Number |
CTRI/2025/02/079871 [Registered on: 03/02/2025] Trial Registered Prospectively |
| Last Modified On: |
31/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study comparing the effect of a prevention bundle on incidence of delirium in critically ill patients |
|
Scientific Title of Study
|
Effectiveness of a prevention bundle on the incidence of delirium
in a critical 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 |
Dr.Anupam S Thomas |
| Designation |
Drnb Critical Care Medicine trainee |
| Affiliation |
Pushpagiri Institute of Medical Sciences and Research Centre |
| Address |
Drnb Critical Care Medicine trainee
Pushpagiri Institute of Medical Sciences and Research Centre
Tiruvalla
Pathanamthitta
KERALA
689101
India |
| Phone |
9496730548 |
| Fax |
|
| Email |
anupamsthomas@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mathew Pulicken |
| Designation |
Head of Department |
| Affiliation |
Pushpagiri Institute of Medical Sciences and Research Centre |
| Address |
Department of Critical Care Medicine
Pushpagiri Institute of Medical Sciences and Research Centre
Tiruvalla
Pathanamthitta
KERALA
689101
India |
| Phone |
7736883088 |
| Fax |
|
| Email |
pulicken@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anupam S Thomas |
| Designation |
Drnb Critical Care Medicine trainee |
| Affiliation |
Pushpagiri Institute of Medical Sciences and Research Centre |
| Address |
Drnb Critical Care Medicine trainee
Pushpagiri Institute of Medical Sciences and Research Centre
Tiruvalla
Pathanamthitta
KERALA
689101
India |
| Phone |
09496730548 |
| Fax |
|
| Email |
anupamsthomas@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pushpagiri Institute of Medical Sciences and Research Centre
Tiruvalla
Kerala
India
689101
|
|
|
Primary Sponsor
|
| Name |
Dr Anupam S Thomas |
| Address |
Drnb Critical Care Medicine Trainee
Department of Critical Care Medicine
Pushpagiri Institute of Medical Sciences and Research Centre
Tiruvalla
Kerala
India
689101
|
| Type of Sponsor |
Other [Primary investigator] |
|
|
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 Anupam S Thomas |
Pushpagiri Institute of Medical Sciences and Research Centre |
MICU1
Department of Critical Care Medicine
Pushpagiri Institute of Medical Sciences and Research Centre
Tiruvalla
689101
Pathanamthitta
KERALA |
9496730548
anupamsthomas@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PUSHPAGIRI INSTITUTE OF MEDICAL SCIENCES AND RESEARCH CENTRE I N S T I T U T I O N A L E T H I C S C O M M I T T E E |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G00-G99||Diseases of the nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Delirium prevention bundle |
Give the patient MORE
M Music Early Mobilization
O Opening of blinds during day switching Off lights at night
R Reorientation and cognitive stimulation
E Eye Ear protocols Eye bandage and ear plugs during sleep if they ask for it
Spectacles and Hearing aid for those who use it
Duration of interventio 3 months
|
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Admission to the MICU during the specified period
Age more than18 years |
|
| ExclusionCriteria |
| Details |
1 Any amount of time was spent in an ICU (internal
or external) before Critical care unit admission
2 Cerebral palsy mental retardation, or stroke documented
3 Admission to the MICU1 before the first day of evaluation period
4. MICU stay less than or equal to 24 hours
5. Presentation to the MICU delirious
6. Do not have a recorded CAM ICU Score.
7. Do not give consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of delirium in ICU of a tertiary care centre |
Baseline and 3 months after implenting prevention bundle |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Association of delirium with risk factors |
3 months |
|
|
Target Sample Size
|
Total Sample Size="88"
Sample Size from India="88"
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)
|
12/02/2025 |
| 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="0"
Months="7"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response (Others) - NIL
- By what mechanism will data be made available?
Response (Others) - NIL
- For how long will this data be available start date provided 01-01-2026 and end date provided 01-05-2026?
Response (Others) - NIL
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The study will happen in 2 phases. Phase 1 cosnsists of a 3 month baseline assessment period where all patients who meet the inclusion criteria will be screened for the presence of delirium Phase 2 consists of a 3 month assessment period for delirium after implementation of a delirium prevention bundle which was mentioned above The doctors and nurses will be trained on implementation of protocol After data collection of phase 2 the incidence of delirium will be calculated The staff willl also be queried based on a questionnaire the difficulties faced during implementation.
|