| CTRI Number |
CTRI/2025/10/096371 [Registered on: 23/10/2025] Trial Registered Prospectively |
| Last Modified On: |
22/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Effectiveness of multimodal strategies for prevention of acute confusional state, intellectual disability, emotional trauma, to improve overall quality of life and better clinical outcomes among patients on ventilator |
|
Scientific Title of Study
|
Effectiveness of a Multimodal Delirium Prevention Bundle on occurrence of delirium, cognitive function, Post traumatic stress disorder, health related Quality of Life and clinical outcomes among Patients on mechanical ventilator in a selected tertiary care hospital, Coimbatore. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ramani R |
| Designation |
Assistant Professor |
| Affiliation |
KMCH College of Nursing |
| Address |
259,267 Phase II Balaji Nagar, kalapatti Post, Coimbatore 641048 Tamil Nadu 259,267 Phase II Balaji Nagar, Kalapatti post, Coimbatore 6410148 TAMIL NADU Coimbatore TAMIL NADU 641048 India |
| Phone |
8377077626 |
| Fax |
0000 |
| Email |
ramanisuresh18ks@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Madhavi S |
| Designation |
Professor cum Principal |
| Affiliation |
KMCH College of Nursing |
| Address |
259,267 Phase II Balaji Nagar, kalapatti post, Coimbatore 641048
Tamil Nadu 259,267 Phase II Balaji Nagar, Kalapatti post, Coimbatore 641048 Coimbatore TAMIL NADU 641048 India |
| Phone |
9444150993 |
| Fax |
0000 |
| Email |
principal@kmchcon.ac.in |
|
Details of Contact Person Public Query
|
| Name |
Ramani R |
| Designation |
Assistant Professor |
| Affiliation |
KMCH College of Nursing |
| Address |
259, 267 PHASE II BALAJI NAGAR, kALAPATTI POST, COIMBATORE 641048
TAMIL NADU 259,267 PHASE II BALAJI NAGAR, KALAPATTI POST,COIMBATORE 641048, TAMIL NADU Coimbatore TAMIL NADU 641048 India |
| Phone |
8377077626 |
| Fax |
0000 |
| Email |
ramanisuresh18ks@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kovai Medical Center and Hospital, post box No 3209,Avanashi road, Coimbatore 641014,Tamil Nadu,India |
|
|
Primary Sponsor
|
| Name |
RAMANI R |
| Address |
KMCH COLLEGE OF NURSING
KALAPATTI POST, COIMBATORE 641048 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| RAMANI R |
KOVAI MEDICAL CENTER AND HOSPITAL |
Department of Critical Care medicine, Postbox No3209
Avanashi road
Coimbatore641014
Coimbatore
TAMIL NADU Coimbatore TAMIL NADU |
8377077626 0000 ramanisuresh18ks@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL HUMAN ETHICS COMMITTEE KMCH INSTITUTE OF ALLIED HEALTH SCIENCE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F05||Delirium due to known physiological condition, (2) ICD-10 Condition: G94||Other disorders of brain in diseases classified elsewhere, (3) ICD-10 Condition: G94||Other disorders of brain in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
conventional care with existing bundle |
sedation,analgesics,muscle relaxant,SAT,SBT,early bed mobilization will be given till patient is transferred out from ICU |
| Intervention |
MULTIMODAL DELIRIUM PREVENTION BUNDLE |
Delirium prevention by Non Pharmacological management and Environmental control to
maintain the sleep hygiene, Family Engagement, Empowerment
Gaining insight into patient needs till patient is transferred out from ICU
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients on mechanical ventilator for more than 24 hours in ICU
Patients who are admitted in ICU for the first time
Patients with RASS score of -3 to + 4 and GCS score of 8-10 T |
|
| ExclusionCriteria |
| Details |
Patients who had the history of mental illness including Para suicidal
The patients who have previous history of ICU admission
Patients with history of head injury
Patients with known thyroid, adrenal and parathyroid disorders
Patients who had the history of substance abuse like alcohol, drugs etc
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of agitation and delirium among patients in control and experimental group. |
Assessment of agitation and delirium on every 2nd day till the participant is transferred out from ICU and at the time of transfer out of ICU |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| cognitive function, post traumatic stress disorder & quality of life of patients in both control & experiment group |
assessment of cognitive function & Post traumatic stress disorder at the time of hospital discharge & at one month post hospital discharge assessment of Health related Quality of Life at three month of post hospital discharge
|
|
|
Target Sample Size
|
Total Sample Size="240" Sample Size from India="240"
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)
|
09/02/2026 |
| 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 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
|
Primary objective 1. Evaluate the effectiveness of multimodal delirium prevention bundle on delirium occurrence, cognitive function and clinical outcomes among patients on mechanical ventilator admitted in an Intensive care unit. Secondary Objectives 1. Evaluate the effectiveness of multimodal delirium prevention bundle on Post traumatic stress disorder and health related quality of life among patients on mechanical ventilator admitted in an Intensive care unit. 2. Associate the delirium occurrence and selected clinical outcomes with the demographic variables. 3. Determine the association of demographic and clinical variables with cognitive function, Post traumatic stress disorder and Health related Quality of life of patients on mechanical ventilator. HYPOTHESIS H1 There will be a significant difference in Agitation scores and the Occurrence of delirium before and after implementation of Multimodal delirium prevention bundle among patients on mechanical ventilation assistance in an Intensive care unit. H2 There will be a significant difference between Agitation and the Occurrence of delirium before and after implementation of conventional existing care bundle among patients on mechanical ventilator admitted in an Intensive care unit. H3 There will be a significant difference in the delirium occurrence, cognitive function, and selected clinical outcome between patients who receive existing conventional care bundle and those who receive multimodal delirium prevention bundle. H4 There will be a significant difference in the Post traumatic stress disorder and health related quality of life between patients who receive conventional existing care bundle and those who receive multimodal delirium prevention bundle. Plan for Implementation of Intervention The participants in both the ICUs ICU I and ICU II will be allocated to control group once they fulfil the inclusion criteria. The nurses in both the ICUs will assess agitation and delirium status of the participants using RASS and ICDSC checklist. participants in control group will receive the conventional care with the existing bundle till they are transfered out from ICU. Posttest assessment on RASS score and the ICDSC score will be done on every 2nd day and at the time of transfer out from the ICUs. Posttest assessment on cognition functioning and Post traumatic stress disorder will be done at the time of hospital discharge and also at one month of post hospital discharge. Participants health related Quality of Life will be assessed at three months of post hospital discharge. After two weeks of exclusive training on implementation of multimodal delirium prevention bundle for both the ICU nurses by the researcher, the participants from both the ICUs ICU I and ICU II will be allocated to experimental group once they fulfill the inclusion criteria. The nurses in both the ICUs will assess the agitation and delirium status of the participants in the experimental group, While nursing the participants in the experimental group the nurses will spend time with the participants by talking about the day, date, time and place, discuss the current events what is going on around them, and provide care giver name, place calendar and clock in patient room. Will encourage communication using communication boards while patient is on mechanical ventilator and will provide reorientation to patient about time, place and persons. Sleep hygiene of the participants will be maintained by providing ear plugs, maintaining silence by placing speak softly sign boards, monitoring and maintaining sound level of less than 40 dB as per WHO recommendations inside ICU using sound level meter with proper alarm management for noise control, will provide day and night variations by providing eye-shields and switching off of bright lights during sleep hours (11pm -5 am), ‘Time-out” to minimize the interruption of sleep. No procedure or any interventions will be allowed between 11pm - 5 am. (unless emergency). Family members will be allowed to visit and talk to the participant for 15 minutes daily three times a day between 6 am-7 am morning, 12.30 pm-1.30 pm during afternoon and between 6.30 pm- 7.30 pm in the evening. Family members will be allowed to perform small acts like holding hands, limb massaging, hair combing under the supervision of the ICU staff and will also ensure 15 minutes of time period will be given for the family member to show their love and affection. Family members will be encouraged to show some photos of their loved ones to make them to recall and also to talk about their favorite topics , events which they like the most. Will Gain insight into patients need by acknowledging the participants personal needs and sensory needs will be met by providing hearing aids and eye glasses. Will encourage them to read newspapers. Participant habits will be addressed and met with an attempt to bring their routine by providing music therapy (will play their favorite music using ear phones), placing their loved objects , photos at the bedside and showing them frequently and use scents with the fragrance they prefer. These multimodal delirium prevention bundle with non -pharmacological interventions will be carried out daily during morning for the participants in the experimental group by the staff nurses trained in implementing the multimodal delirium prevention bundle who nurses the participants till they are discharged from ICU. Posttest assessment on RASS score and the ICDSC score will be done on every 2nd day and at the time of transfer out from ICU. Posttest assessment on Cognition functioning and Post traumatic stress disorder will be done at the time of hospital discharge and also at one month of post hospital discharge. Participants health related Quality of Life will be assessed at three months of post hospital discharge.
|