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CTRI Number  CTRI/2018/02/011867 [Registered on: 13/02/2018] Trial Registered Prospectively
Last Modified On: 19/11/2019
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   This is a scientific study to find out the occurrence rate ofdelirium in intensive care unit (ICU) patients and how it impacts their convalescence in the ICU. 
Scientific Title of Study   Incidence and outcome of delirium in intensive care unit. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Pradeep Atter 
Designation  Post graduation junior resident 
Affiliation  Govt. Medical College and Hospital 
Address  Dept. of Anaesthesia and Intensive Care Govt. Medical college and Hospital
Sector 32B
Chandigarh
CHANDIGARH
160030
India 
Phone  9465448839  
Fax    
Email  pradeep.atter@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Satinder Gombar 
Designation  Professor and Head 
Affiliation  Govt. Medical College and Hospital 
Address  Dept. of Anaesthesia and intensive care Govt. Medical College and Hospital 32B, Sector 32
Sector 32B
Chandigarh
CHANDIGARH
160030
India 
Phone    
Fax    
Email  dr_sgombar@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Satinder Gombar 
Designation  Professor and Head 
Affiliation  Govt. Medical College and Hospital 
Address  Dept. of Anaesthesia and intensive care Govt. Medical College and Hospital 32B, Sector 32
Sector 32B
Chandigarh
CHANDIGARH
160030
India 
Phone    
Fax    
Email  dr_sgombar@rediffmail.com  
 
Source of Monetary or Material Support  
Dept. of Anaesthesia and Intensive Care Govt. Medical college and hospital sector 32 Chandigarh 
 
Primary Sponsor  
Name  Government Medical College and Hospital 
Address  Sector 32B Chandigarh  
Type of Sponsor  Government medical college 
 
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 
Pradeep Atter  Govt. Medical college and hospital  Intensive Care Unity Dept. of Anaesthesia and Intensive Care Sector 32 B Chandigarh
Chandigarh
CHANDIGARH 
9465448839

pradeep.atter@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (GMCH Chandigarh)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  ICU DELIRIUM,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Patients admitted in the Intensive Care Unit of GMCH 32 
 
ExclusionCriteria 
Details  Patients/Relatives refusing consent
Patients not understanding English, Hindi or Punjabi
Patients admitted with primary diagnosis of delirium tremens
Patients with bilateral hearing loss, or severe aphasia
Patients undergoing cardiac surgeries
Patients with Neuro Trauma and Neurosurgery Patients
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To measure the incidence and prevalence of delirium and its subtypes (hypoactive/hyperactive/mixed) in patients admitted to the ICU of a tertiary care hospital.
 
Daily assessment of all the observations will be done between 6-9 AM using RASS and CAM ICU, SOFA, and BPS.
 
 
Secondary Outcome  
Outcome  TimePoints 
To identify risk factors associated with delirium in ICU patients  Daily assessment of all the observations will be done between 6-9 AM using RASS and CAM ICU, SOFA, and BPS. 
To measure the impact of delirium on ICU length of stay.  Calculated using APACHE IV using worst values during first 24 hours of admission. 
 
Target Sample Size   Total Sample Size="105"
Sample Size from India="105" 
Final Enrollment numbers achieved (Total)= "110"
Final Enrollment numbers achieved (India)="110" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/03/2018 
Date of Study Completion (India) 31/01/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 31/01/2019 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   None Yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Intensive Care Unit (ICU) is a specialised ecosystem in a hospital focusing on the critically ill. As our understanding of ICU survivorship has evolved, a common, yet often missed, serious entity has come to limelight, i.e., ICU Delirium. The term “delirium” has often been used, rather liberally, in clinical settings to describe a patient with altered mental status. However, its diagnosis requires specific features to be present.


ICD 10 has characterised delirium as an organic mental disorder under F05 (delirium not induced by alcohol or psychoactive substances) and is defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) as a reduced ability to direct, focus, sustain, and shift attention. However it is time consuming and also presence of an experienced psychiatrist is a prerequisite to using such complex criteria and have for a long time been a hurdle in identification of the disease. A variety of bed side screening tools, therefore, have been developed and validated, for clinical use by a wide range of personnel ranging from nursing staff to intensivists. These include scoring systems like Confusion Assessment Method for the ICU (CAM-ICU) and Intensive Care Delirium Screening Checklist (ICDSC).

The incidence of this vicious disease, in hospitalised patients of course depends upon immense array of factors including patient population studied and screening methods used resulting in colossal differences in incidences reported by various studies. Overall incidence of delirium has been reported to be between 16-89% of all hospitalised patients with the disease burden in ICU settings pegged to be between 20-80% with rates much higher in mechanically ventilated patients.


Variation in incidence has also been seen across its three motor subtypes—hyperactive, hypoactive, and mixed. A study in a medical ICU has reported mixed and hypoactive delirium to be the most prevalent at a rate of 54.9% and 43.5% respectively, of all delirious patients. Despite such a high rate of prevalence in the ICU, delirium often goes unrecognized by clinicians.


In a medical ICU setting, delirium is reported to be associated with increased risk of complications like self extubation, removal of catheters, prolonged hospital stay, and increased health care costs.  Delirium in general is considered to be associated with  high mortality as well. Furthermore, among the various subtypes of delirium, studies in both ICU and non-ICU patients have suggested that hypoactive delirium is associated with poorer prognosis.


With absence of any well-defined pathophysiology, studying the risk factors has been a monumental task. Grossly, the risk factors for delirium can be present before admission to the ICU, which are known as predisposing factors (are difficult to alter), or develop during the course of the illness itself and are called precipitating factors. Precipitating factors, usually a direct or indirect result of the illness or due to therapeutic interventions, represent areas of risk that are potentially modifiable by preventive or therapeutic strategy.


ICU delirium has been characterized as a form of organ dysfunction. Its sheer incidence and impact on mortality, hospital length of stay and cost has been documented by various western studies. However, there is paucity of data pertaining to this condition in India, and its burden is expected to be massive owing to the lack of implementation of institutional protocols to tackle this disease. Hence, the present study is planned with a primary objective to know the incidence/prevalence of delirium in multidisciplinary ICU of a tertiary care hospital and secondary objective to identify risk factors contributing to the disease process and its impact on patient outcome.
 
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