| 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 |
|
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Details of Secondary Sponsor
|
|
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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
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
ICU DELIRIUM, |
|
|
Intervention / Comparator Agent
|
|
|
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
|
|
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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.
|
|
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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. |
|
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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. |