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
|
|
Primary Sponsor
|
Name |
Anushree Naik |
Address |
Manipal college Of Nursing
MAHE Manipal 576104 |
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 |
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
|
|
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
|
|
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). |