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CTRI Number  CTRI/2022/01/039526 [Registered on: 18/01/2022] Trial Registered Prospectively
Last Modified On: 17/01/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Comparative study 
Study Design  Other 
Public Title of Study   Assessment of best scale for ICU confusion  
Scientific Title of Study   A study to assess the best predictive model for ICU delirium among the patients admitted in critical care units of a selected tertiary care hospital in Udupi district, South India  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anushree Naik 
Designation  Post Graduation Student 
Affiliation  Manipal College Of Nursing Manipal 
Address  Manipal College Of Nursing Manipal Academy Of Higher Education Manipal

Udupi
KARNATAKA
576104
India 
Phone  8277554553  
Fax    
Email  anushreenaik98@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Melita Sheilini 
Designation  Asst. Professor Selection grade 
Affiliation  Manipal College Of Nursing Manipal 
Address  Manipal College Of Nursing Manipal Academy Of Higher Education Manipal

Udupi
KARNATAKA
576104
India 
Phone  8095976561  
Fax    
Email  shyli.mel@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Melita Sheilini  
Designation  Asst. Professor Selection Grade 
Affiliation  Manipal College Of Nursing 
Address  Manipal College Of Nursing Manipal Academy Of Higher Education Manipal

Udupi
KARNATAKA
576104
India 
Phone  8095976561  
Fax    
Email  shyli.mel@manipal.edu  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  Anushree Naik 
Address  Manipal college Of Nursing MAHE Manipal 576104 
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 
Anushree Naik  Kasturba Hospital Manipal  ICU1, ICU2, ICU3, First floor CASICU ground floor, Trauma and Emergency block, Department of Critical care and department of emergency medicine, Udupi karnataka.
Udupi
KARNATAKA 
8277554553

anushreenaik98@gmail.com 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R09||Other symptoms and signs involvingthe circulatory and respiratory system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  All the consecutive critically ill adults patients aged above 18 years admitted to the ICU will be enrolled for the study. 
 
ExclusionCriteria 
Details  Patients
1.who are delirious on admission.
2.staying in the ICU for less than 24 hours.
3.Who remains comatose for a sustained period of more than 7 days making it unreliable to assess delirium.
4. with pre existing psychiatric disorder or cognitive dysfunction. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To find out the best predictive model for ICU delirium.  From the time of ICU admission till 7 days or till ICU discharge. 
 
Secondary Outcome  
Outcome  TimePoints 
Assess the adverse effect of delirium among patients admitted in critical care units and find the association between delirium and variables.   From the time of ICU admission till 7 days or till ICU discharge. 
 
Target Sample Size   Total Sample Size="460"
Sample Size from India="460" 
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)   21/01/2022 
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   nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

A study to assess the best predictive model for ICU delirium among the patients admitted in critical care units of a selected tertiary care hospital in Udupi district, South India. The purpose of the study is to compare the predictive performance of two delirium prediction models and to find out the best predictive model for ICU delirium. The findings of the study may help the nurses in screening of patients in ICU for the development of delirium so that timely treatment can be provided. Prior to data collection, Participant Information Sheet (PIS) will be given to all the participants and purpose of the study will be explained to them. Also informed consent will be taken. Data for each delirium predictor will be collected from consecutive patients, immediately after and within 24 hrs of admission to ICU by the researcher using E-PRE-DELIRIC and PRE-DELIRIC model respectively. The delirium will be evaluated once a day daily by the trained research nurse with prior experience in using delirium assessment scales till 7days or ICU discharge. The CAM-ICU will be used for bedside assessment of delirium and patients will be confirmed to have ICU delirium with at least one positive assessment of delirium using the CAM-ICU scale. To avoid false negative delirium screenings, patients who were administered haloperidol, dexmeditomidine or an atypical antipsychotic drug for delirium treatment anytime during their ICU stay while in the enrollment period will also be considered to have delirium.The patient’s level of sedation using the Richmond Agitation-Sedation Scale and current intravenous sedative therapy will be documented at the tie each delirium assessment is completed. Delirium will be assessed when patients are maximally awake (RASS above -3). Patients in coma (i.e., RASS =  -4 or -5) will be labelled as unable to be assessed for delirium. All patients enrolled in the study will be followed until 7 days or till ICU discharge (whichever is early).

 
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