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CTRI Number  CTRI/2020/07/026334 [Registered on: 02/07/2020] Trial Registered Prospectively
Last Modified On: 29/06/2020
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   A study to find out the current management practices of Sleep inducing methods, Pain reducing methods, and treatment used for management of serious disturbances in brain functions in patients admitted in intensive care units. 
Scientific Title of Study   Sedation, Analgesia and Delirium MANagement: an international audit of adult medical, surgical, trauma, and neuro-intensive care patients 
Trial Acronym  SANDMAN Study 
Secondary IDs if Any  
Secondary ID  Identifier 
Project No_900629 Version 3.1_20July2019  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrSheila Nainan Myatra 
Designation  Professor 
Affiliation  Tata Memorial Centre 
Address  Department of Anesthesia, Critical Care and Pain, Main Building, Second Floor, Tata Memorial Hospital, Dr.E Borges Road, Parel

Mumbai
MAHARASHTRA
400012
India 
Phone  9820156070  
Fax    
Email  sheila150@hotmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrSheila Nainan Myatra 
Designation  Professor 
Affiliation  Tata Memorial Centre 
Address  Department of Anesthesia, Critical Care and Pain, Main Building, Second Floor, Tata Memorial Hospital, Dr.E Borges Road, Parel


MAHARASHTRA
400012
India 
Phone  9820156070  
Fax    
Email  sheila150@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  DrSheila Nainan Myatra 
Designation  Professor 
Affiliation  Tata Memorial Centre 
Address  Department of Anesthesia, Critical Care and Pain, Main Building, Second Floor, Tata Memorial Hospital, Dr.E Borges Road, Parel


MAHARASHTRA
400012
India 
Phone  9820156070  
Fax    
Email  sheila150@hotmail.com  
 
Source of Monetary or Material Support  
Tata Memorial Hospital, Dr.E Borges Road, Parel Mumbai Maharashtra India 400012 
 
Primary Sponsor  
Name  Tata Memorial Centre 
Address  Dr.E Borges Road Parel Mumbai Maharashtra, India 400012 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
Not Any  Nil 
 
Countries of Recruitment     Afghanistan
Albania
Algeria
Andorra
Angola
Antigua and Barbuda
Argentina
Armenia
Australia
Austria
Azerbaijan
Bahamas
Bahrain
Bangladesh
Barbados
Belarus
Belgium
Belize
Benin
Bhutan
Bolivia
Bosnia and Herzegovina
Botswana
Brazil
Brunei Darussalam
Bulgaria
Burkina Faso
Burundi
Cambodia
Cameroon
Canada
Cape Verde
Central African Republic
Chad
Chile
China
Colombia
Comoros
Congo
Cook Islands
Costa Rica
Cote d'Ivoire
Croatia
Cuba
Cyprus
Czech Republic
Democratic People's Republic of Korea
Democratic Republic of the Congo
Denmark
Djibouti
Dominica
Dominican Republic
Ecuador
Egypt
El Salvador
Equatorial Guinea
Eritrea
Estonia
Ethiopia
Fiji
Finland
France
Gabon
Gambia
Georgia
Germany
Ghana
Greece
Grenada
Guatemala
Guinea
Guinea-Bissau
Guyana
Haiti
Honduras
Hong Kong
Hungary
Iceland
India
Indonesia
Iran (Islamic Republic of)
Iraq
Ireland
Israel
Italy
Jamaica
Japan
Jordan
Kazakhstan
Kenya
Kiribati
Kuwait
Kyrgyzstan
Lao People's Democratic Republic
Latvia
Lebanon
Lesotho
Liberia
Libyan Arab Jamahiriya
Lithuania
Luxembourg
Madagascar
Malawi
Malaysia
Maldives
Mali
Malta
Marshall Islands
Mauritania
Mauritius
Mexico
Micronesia (Federated States of)
Monaco
Mongolia
Montenegro
Morocco
Mozambique
Myanmar
Namibia
Nauru
Nepal
Netherlands
New Zealand
Nicaragua
Niger
Nigeria
Niue
Norway
Oman
Other
Pakistan
Palau
Panama
Papua New Guinea
Paraguay
Peru
Philippines
Poland
Portugal
Qatar
Republic of Korea
Republic of Moldova
Romania
Russian Federation
Rwanda
Saint Kitts and Nevis
Saint Lucia
Saint Vincent and the Grenadines
Samoa
San Marino
Sao Tome and Principe
Saudi Arabia
Senegal
Serbia
Seychelles
Sierra Leone
Singapore
Slovakia
Slovenia
Solomon Islands
Somalia
South Africa
Spain
Sri Lanka
Sudan
Suriname
Swaziland
Sweden
Switzerland
Syrian Arab Republic
Taiwan
Tajikistan
Tanzania
Thailand
The former Yugoslav Republic of Macedonia
Timor-Leste
Togo
Tonga
Trinidad and Tobago
Tunisia
Turkey
Turkmenistan
Tuvalu
Uganda
Ukraine
United Arab Emirates
United Kingdom
United Republic of Tanzania
United States of America
Uruguay
Uzbekistan
Vanuatu
Venezuela (Bolivarian Republic of)
Viet Nam
Yemen
Zambia
Zimbabwe  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sheila Myatra  Tata Memorial Hospital  Room no 6 Department of Anesthesia, Critical Care and Pain, Main Building Second floor Tata Memorial Hospital, Parel Mumbai
Mumbai
MAHARASHTRA 
09820156070

sheila150@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R098||Other specified symptoms and signsinvolving the circulatory and respiratory systems,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. All adults (≥18 years) admitted to a participating ICU who are invasively mechanically ventilated for more than 12 hours will be included.
2. We will include medical, surgical, and neurological patients. 
 
ExclusionCriteria 
Details  There are no exclusion criteria 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To capture an overview of sedation, analgesia and delirium management strategies used in intensive care units around the world.  3 months after enrollment 
 
Secondary Outcome  
Outcome  TimePoints 
To describe international practice in ICU, and practice variation in the use of drugs, and monitoring for PAD;  3 months after enrollment 
To quantify the adherence to the PAD clinical guidelines  3 months after enrollment 
To describe and compare management between specific ICU patient groups:1 Medical patients (specifically sepsis and acute respiratory distress syndrome (ARDS))
2 Surgical patients
3Trauma and Burns patients
4 Neurocritical care patients
5 Cardiogenic shock patients
6 Patients receiving palliative care 
3 months after enrollment 
 
Target Sample Size   Total Sample Size="2000"
Sample Size from India="20" 
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)   31/07/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  15/07/2020 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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)?  

Brief Summary  

Sedation management (medicine and procedures used to keep patient asleep and calm) in critically ill patients has a significant impact on their short-term and long-term patients condition and disease status. Despite strong evidence and prescriptive international guidelines, there appears to be a huge difference in practices followed by doctors worldwide. However, there are no large-scale multinational data describing these practices in the intensive care unit (ICU).

Sandman study is international audit we will collect data in academic and non-academic ICUs from all over the world. In this study only data from the patients chart will be collected. Data regarding sedation (medicine and practices use to induce sleep in patients), analgesia (pain killers and methods use to reduce pain) and delirium (acute state of confusion), their rate of occurrence, various treatment modalities and guidelines followed in treatment will be collected to check whether clinicians stay adhere to guidelines or not.

Tata Memorial centre will be one of the participating centre. We will only collect the data related to patient’s demographics like ICU admission and discharge date, reason of admission, age sex, disease condition, treatment received during ICU stay a) like sedation medicine used, reason to use, dose and type of medicines used, b) medication used to treat agitation or restlessness and to treat psychological conditions. c) rate of occurrence of acute mental confusion among patient admitted in ICU, d) use of pain killer practices and medication used in ICU.

It is important to understand current practices around the world. The data generated from this study will inform research, educational and quality improvement initiatives for a diverse patient population and help in future patient management.

 
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