The SAnDMAN study Sedation, Analgesia and Delirium MANagement

What?

SANDMAN is an observational study that will describe sedation, analgesia, and delirium strategies used in ICUs around the world.
The study is endorsed by the ESICM Health Services Research & Outcome (HSRO), Neuro-Intensive Care (NIC) and Peri-Operative Intensive Care (POIC) sections.
SAnDMAN received an ESICM 2018 trials group award.

 

Why?

Pain and sedation management has a significant impact on short-term and long-term outcomes of critically ill patients. Despite strong evidence and international guidelines, there is tremendous variability in management internationally. It is vital to understand current practices around the world, however there are no large-scale multinational data describing sedation, analgesia and delirium practices in the intensive care unit (ICU).

Design: Retrospective study to describe patterns of sedative, analgesic, and antipsychotic drug use and adherence to evidence-based strategies and guidelines. We will collect data in upper and lower/middle income countries, academic and non-academic ICUs, and on heterogeneous populations of critically ill patients.

Sample Size: We aim to recruit more than 2000 patients internationally from a minimum of 100 ICUs representing geographic and socio-economic diversity.

 

When?

SAnDMAN will start enrolling patients in mid 2019.

 

What data is required?

Inclusion criteria: For a period of 14 consecutive days, adults who are newly admitted to a participating ICU AND are invasively mechanically ventilated for more than 12 hours will be included. Each site will enrol a maximum of 20 patients.

Data Collection: Baseline patient demographic data will be collected on the day 1 of mechanical ventilation. Thereafter, data on sedation, analgesia, delirium, and physical restraint will be collected daily until discharge or death. Data entry will be facilitated by an electronic Case Report Form (eCRF). No patient identifying information will be collected.

 

Do I need IRB approval?

Ethics committee and appropriate local regulatory approvals must be obtained by each National Coordinator (NC) /Principle Investigator (PI). As SAnDMAN is a retrospective no-risk study, a waived informed consent model will be used.

 

How is the data that is collected managed?

All data is anonymised and cannot be linked to individual subjects. The data will be stored securely and all procedures regarding data management will comply with EU directive on data protection 95/46/EC.

 

Who owns and can access the collected data? 

Each site investigator is responsible for his own data and may request an export of his data after the database is locked. The request should be addressed to the Principal Investigator.

 

Is there any financial compensation?

There is no financial compensation for participation. Participation in the trial is completely voluntary.

 

How do I participate?

Please register through the ESICM trials group platform here, or e-mail one of the principle investigators or steering committee members.

 

SAnDMAN Executive Committee Members

Sangeeta Mehta
MD
Lara Prisco
MD
Lisa Burry
PharmD
Michelle Chew
MBBS PhD

SAnDMAN Steering Committee Members

Geert Meyfroidt MD,  Giuseppe Citerio MD, Dylan deLange MD, Ib Jammer MD, Fabio Silvio Taccone, MD Björn Weiss MD, Jorge Salluh MD

Any further Questions?

You can contact the ESICM office: Guy FRANCOIS / Sherihane BENSEMMANE – research@esicm.org

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