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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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. 


 
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