Indian Intensive Care Case Mix and Practice Patterns Study - II
Conditions: Critical Illness
Sponsor: Indian Society of Critical Care Medicine

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Study Protocol Version 1.0 dated 31st May 2018 
 
 
 
 
 
 
 
 
Indian Intensive Care Case Mix and Practice Patterns Study II 
(INDICAPS II) 
 
 
 
 
 
August 23, 2018; October 25, 2018; December 13, 2018; April 11, 2019 

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Study Protocol Version 1.0 dated 31st May 2018 
 
Indian Intensive Care Case Mix and Practice Patterns Study II (INDICAPS II)  
 
 
Table of contents  
1 General information ………………………………………………………... 3 
1.1 Organization ……………………………………………………….....3  
1.2 Protocol summary …..……………………………………………..... 4  
2 Rationale and aim of the study …………………………………………..... 5  
3 Study outcomes..............................................................…………………...... 5  
3.1 Primary outcome …………………………………………………..... 5 
3.2 Secondary outcomes ………………………………………………... 5 
4 Study description …………………………………………………………... 5 
4.1 Study design ……………………………………………………….... 5  
5 Study population ………………..…………………………………………... 5 
5.1 Inclusion criteria …………………………………………………….. 5 
5.2 Exclusion criteria ………………………………………………….... 6 
6 Detailed study course …………..………………………………………….... 6  
6.1 Patients' enrollment .................……………………………………….. 6  
6.2 Ethics Committee approval .………………………………………….. 6  
6.3 Therapeutic interventions ……..……………………………………... 6  
6.4 Daily documentation ……........………………………………………. 6  
 
7 Organization ……………………………………………………………….... 6 
7.1 Documentation ……………………………………………………….. 6  
7.2 Collecting data ……………………………………………………….. 6 
7.3 Data management and archiving ……………………………………... 7  
7.3.1 Data property …………………………………………...….. 7  
7.3.2 Data control ………………………………………………... 7 
7.3.3 Subsequent use of data …………………………………….. 7  
7.3.4 Archiving ………………………………………………….. 7  
7.3.5 Publication rules ……………………………………………. 7 
7.4 Sponsorship ………………………………………………………….... 7  
 
8 Statistical analysis ……………………………………………………………. 7  
9 References …………………………………………………………………….. 7  
 
 
 
 
 
 
 
 
 
 

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Study Protocol Version 1.0 dated 31st May 2018 
 
Indian Intensive Care Case Mix and Practice Patterns Study II (INDICAPS II)   
 
 
General information  
1.1 Organization  
 
Steering committee  
JV Divatia (Mumbai) 
FN Kapadia (Mumbai) 
N Ramkrishnan (Chennai) 
Subhash Todi (Kolkata) 
Pravin Amin (Mumbai) 
Kapil Zirpe (Pune) 
Yatin Mehta (Gurgaon) 
Subhal Dixit (Pune) 
Pradeep Bhattacharya (Bhopal)  
Rajesh Pande (Delhi) 
Srinivas Samavedam (Hyderabad)  
 
 
 
Coordinating center  
Department of Anaesthesia, Tata Memorial 
Hospital, E. Borges Road,  Parel, Mumbai 
400012.  

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1- Protocol summary 
 
Indian Intensive Care Case Mix and Practice Patterns Study II (INDICAPS II)  
 
Design  
 
Multicenter, All India one-day prevalence 
study  
Target population  
All patients present in the ICU on August 
23, 2018; October 25, 2018; December 13, 
2018; April 11, 2019 
 
Interventions  
No intervention  
Subgroup/  
Sub-study analysis  
 
- Case-mix, severity of illness, prevalence 
of infection, hemodynamic monitoring and  
therapy, mechanical ventilation practices, 
nutrition and outcome  
- - Epidemiology and variations in antibiotic 
use  
- Patterns of microorganisms and outcome  
- Prevalence and outcome of specific 
tropical febrile ilmesses, including malaria, 
dengue fever, leptospirosis, scrub typhus 
- Prevalence and outcome of toxins and 
poisonings 
- Relation of ICU and hospital 
organizational issues to prevalence of 
infection and outcome  
- Organisation of intensive care services  
- End of life - Ethical decisions  
 
Study duration  
One year (point prevalence on 4 days) 
 
Primary Outcome 
ICU mortality at 30 days from the Study 
day 
Secondary Outcomes 
Hospital Mortality, ICU and hospital length 
of stay 
Follow up period  
Hospital discharge 
 

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2- Rationale and aim of the study  
 
INDICAPS was the first large scale, multicentre survey launched by the ISCCM. The aim 
was to gather information about ICUs, organizational characteristics, patient casemix, the 
types and severity of illness, monitoring and therapeutic modalities used, types of 
infections, and other such data. This was performed between July 2010 and April 2011 
and published in 2016.[1] Over the last 8 years, there has been a significant difference in 
the delivery of intensive care services, critical care education, socioeconomic indicators, 
antibiotic resistance patterns and other aspects of practices in Indian ICUs. It is therefore 
necessary to revisit and resurvey the current trends in intensive care practices in India, 
and to reflect the vast spectrum of critical care illness, services and practices.  
 
Similar to INDICAPS, which was a point-prevalence study of all patients present in the 
ICU on four different days over a one-year period, INDICAPS II will record data of all 
patients admitted to the ICU on 4 different days.  
 
This cross-sectional design makes it easy to follow, and spares busy clinicians the effort 
of maintaining data daily throughout the ICU stay of every patient. This will generate 
important data on Indian critical care. 
 
 
3- Study outcomes  
 
3.1 Primary outcome  
The primary outcome measure is all-cause ICU mortality at 30 days from the 
study day. 
3.2 Secondary outcomes  
The secondary outcome measures are:  
1. Hospital mortality   
2. ICU and hospital length of stay  
 
4- Study description  
 
4.1 Study design  
A multicenter, all-India observational, one-day prevalence study, performed 
on four separate days.  
 
5- Study population  
 
5.1 Inclusion criteria  
All patients present in the ICU on 
August 23, 2018; October 25, 2018; December 13, 2018; April 11, 2019 
 
5.2 Exclusion criteria  
There are no exclusion criteria, all patients should be included. 

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6- Detailed study course 
  
6.1 Patients’ enrollment  
Patients’ enrollment will be on each of four study days, August 23, 2018; 
October 25, 2018; December 13, 2018; April 11, 2019 
All patients in the ICU on those days for the 24 hours starting 0800 am to 
0800 am next day. 
 
6.2 Ethics committee approval  
Even though this is a purely epidemiological study (with entirely anonymous 
data collection), it is advised to submit the protocol to the local ethics 
committee for approval.  If your hospital does not have an ethics committee, 
please contact the co-ordinating centre. 
 
6.3 Therapeutic intervention  
The study is a purely observational study, no interventions are planned.  
 
6.4 Daily documentation  
Data collection includes:  
a. On admission: demographic characteristics, comorbidities, source of 
admission, primary and secondary admission diagnoses,  
b. Baseline data (on the study day), including parameters used to calculate 
SAPS II score and SOFA score and infections, 
c. Information on monitoring modalities, mechanical ventilation, nutrition, 
fluid therapy, other routine ICU practices  
c. Outcome at ICU and hospital discharge.  
 
7- Organization  
 
7.1 Documentation  
Data will be recorded using pre-printed case report forms (CRF) by the 
attending intensivist or a trained research nurse. There are two CRFs:  
 
Form 1: ICU data form: This includes data on local organizational and 
patients’ care facilities in each center.  This has to be filled once only 
Form 2: Individual patient data form:  This contains individual patient 
information. A separate form is to be filled for each patient.  
 
7.2 Collecting data  
Data should preferably be entered electronically on the website 
http://isccm.org  
Those ICUs that are unable to do so can mail paper forms to the 
coordinating center (Department of Anaesthesia, Tata Memorial Hospital, E. 
Borges Road,  Parel, Mumbai 400012).  
 

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7.3 Data management and archiving  
7.3.1 Data property  
The individual data provided by a participating ICU are primarily the 
property of the ICU who generated the data. All investigators have the 
right to access their data at any time.  
 
7.3.2 Data control  
Data control will involve the following levels  
1. All participants will be provided with detailed information, including 
exhaustive definitions of medical terms. The coordinating center will 
provide a rapid response for any query throughout the study period 
(Please see contact information).  
 
2. Data plausibility check will start at the entry level electronically, setting 
validity limits for each variable. Investigators will be queried in case of 
outliers or excessive numbers of missing values.  
 
7.3.3 Subsequent use of data  
The steering committee, on behalf of the investigators has the right to use 
all data that are pooled in the databank for scientific purposes. 
Investigators will be regularly informed about ongoing study activities. All 
participants have the right to access the data, pooled in the databank, for 
research purposes after the research project has been terminated, and with 
the approval of the steering committee. A copy of the databases generated 
by the project can only be provided to third-part entities after specific 
approval by the participating ICUs.  
 
7.3.4 Archiving  
A copy of the electronic databank will be kept in the coordinating centers 
and preserved for 15 years for subsequent use by the steering committee 
and investigators. It is recommended that a copy of CRFs be kept at each 
center for future reference.  
 
7.3.5 Publication rules  
Authorship will take the following elements into account: study design, 
study organization, data collection, patient enrolment, data analysis, and 
contribution to the manuscript  
 
7.4 Sponsorship  
This study is funded by the Indian Society of Critical Care Medicine.  
 
 
8- Statistical analysis  
 
Statistical analysis will be performed using SPSS for windows (Chicago, USA). 
 

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9 – Reference 
 
Divatia JV, Amin PR, Ramakrishnan N, Kapadia FN, Todi S, Sahu S, et al. Intensive 
Care in India: The Indian Intensive Care Case Mix and Practice Patterns Study. Indian J 
Crit Care Med 2016;20:216-25