Ignite Creation Date:
2024-05-05 @ 4:40 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00298493
Status:
COMPLETED
Last Update Posted:
2006-03-02
First Post:
2006-02-28
Brief Title:
Daily Sedative Interruption in Critically Ill Patients Being Managed With a Sedation Protocol
Sponsor:
Mount Sinai Hospital Canada
Organization:
Mount Sinai Hospital Canada
Study Overview
Official Title:
A Randomized Trial of Daily Sedative Interruption in Critically Ill Patients Being Managed With a Sedation Protocol - A Pilot Study
Status:
COMPLETED
Status Verified Date:
2006-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
All critically ill mechanically ventilated patients in the Intensive Care Unit receive medications to relieve pain and anxiety However accumulation of these medications can be associated with serious complications most notably longer time on the breathing machine and in the ICU Two strategies have been shown to dramatically improve patient outcomes nurse-directed protocols for giving sedation and daily interruption of sedation However these strategies have not been widely adopted because of physicians concerns and because it is unclear which strategy is better Given that patient outcome is improved with either of these strategies the fundamental question that arises is whether patients managed with a combination of two strategies which both reduce drug accumulation protocolized sedation and daily interruption have an even better outcome than patients managed with only one of them protocolized sedation We propose a multicenter study in which 700 critically ill mechanically ventilated patients will have their sedation managed with protocolized sedation alone or both strategies Both groups of patients will have the following recorded ICU and hospital lengths of stay mortality total sedative drug use ICU human resources used side effects and recall of their ICU stay The results of this large multi-center trial will help to inform best practice with regard to sedation management of critically ill patients in Canada and elsewhere In addition reducing ICU stay could be economically attractive as the cost of an ICU day in Canada is approximately 3000
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None