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CTRI Number  CTRI/2020/09/027721 [Registered on: 10/09/2020] Trial Registered Prospectively
Last Modified On: 03/09/2020
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   to study the use of sedatives in the intensive care unit and their impact on the patient  
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  
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  JAYA WANCHOO 
Designation  ASSOCIATE DIRECTOR 
Affiliation  medanta the medicity 
Address  ICU 3-NEUROCRITICAL CARE ICU,MEDANTA THE MEDICITY SECTOR 38 GURGAON
sector -38,gurgaon
Gurgaon
HARYANA
122018
India 
Phone  8130245666  
Fax    
Email  dr_jayawanchoo@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  JAYA WANCHOO 
Designation  ASSOCIATE DIRECTOR 
Affiliation  medanta the medicity 
Address  ICU 3-NEUROCRITICAL CARE MEDANTA THE MEDICITY SECTOR 38 GURGAON
sector -38,gurgaon
Gurgaon
HARYANA
122018
India 
Phone  8130245666  
Fax    
Email  dr_jayawanchoo@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  JAYA WANCHOO 
Designation  ASSOCIATE DIRECTOR 
Affiliation  medanta the medicity 
Address  ICU 3-NEUROCRITICAL CARE MEDANTA THE MEDICITY SECTOR 38 GURGAON
sector -38,gurgaon
Gurgaon
HARYANA
122018
India 
Phone  8130245666  
Fax    
Email  dr_jayawanchoo@yahoo.co.in  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  Nuffield dept of clinical neurosciences 
Address  University of Oxford  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrJaya Wanchoo  medanta the medicity   ICU 3-NEUROCRITICAL CARE ICU 1st floor
Gurgaon
HARYANA 		 8130245666

dr_jayawanchoo@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Medanta Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G969||Disorder of central nervous system, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Adult patients admitted to ICU who are invasively mechanically ventilated for more than 12 hours,medical,surgical,neurology and neurological patients 
 
ExclusionCriteria 
Details  paediatric patients(<18 years) 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
USE OF ANALGESICS,SEDATIVES,ANTIPSYCHOTICS,PARALYTICS AND USE OF ASSESSMENT TOOLS FOR PAIN,SEDATION,DELIRIUM  7 DAYS OF VENTILATION 
 
Secondary Outcome  
Outcome  TimePoints 
USE OF SEDATION,ANALGESIA,DELIRIUM,RESTRAINT PROTOCOLS ,ADHERENCE TO EXISTING GUIDELINES ON THE MANAGEMENT OF SEDATION,ANALGESIA AND DELIRIUM  7 DAYS OF VENTILATION 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   01/11/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
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 Applicable 
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)?  

Response - NO
Brief Summary   Sandman study is an international multicentre retrospective observational study designed to capture an overview of the sedation and analgesic practices in mechanically  ventilated patients around the world.This study has been endorsed from three ESICM sections.As it is a no-risk study ,without any deviation from usual clinical protocols,a waived consent model will be used .
ICUs from 6 regions will be represented-Europe,North America,South America,Africa,Asia and Oceania.It aims to recruit >2000 patients from a minimum of 100 ICUs.Each investigator will collect data for the first 7 days of mechanical ventilation for the last 20 consecutive patients.
 
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