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
|
|
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
|
|
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. |