Ignite Creation Date:
2024-05-05 @ 5:29 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00466492
Status:
COMPLETED
Last Update Posted:
2010-03-19
First Post:
2007-04-26
Brief Title:
Advantages and Disadvantages of Long Term Sedation in Intensive Care Unit Patients
Sponsor:
Odense University Hospital
Organization:
Odense University Hospital
Study Overview
Official Title:
Advantages and Disadvantages of Long Term Sedation in ICU Patients
Status:
COMPLETED
Status Verified Date:
2009-06
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:
The purpose of the study is to determine whether sedation of the critical ill patient prolongs the time receiving mechanical ventilation
Detailed Description:
The golden standard is to sedate critical ill patients receiving mechanical ventilation with daily wake up trials This is shown to reduce the time receiving mechanical ventilation compared to no wake up trials
We would like to study whether no sedation but only analgesics administered as bolus doses reduce the time receiving mechanical ventilation The study is planned as a randomised prospective study not blinded The control group is patients receiving sedation with daily wake up trials The intervention group is not sedated but receives bolus doses of analgesics morphine The endpoint is the time spend receiving mechanical ventilation lengths of stay on the intensive care unit and total lengths of stay on the hospital
We also examine the frequency of ventilator associated pneumonia and CT scans of cerebrum Also we would like to examine the long term psychological effects of sedation we plan to send some of the patients to a post traumatic stress screening The effect on the next of kin we plan to study with a questionnaire As a last thing we would like to study the workload on the nurses
We would like to study whether no sedation but only analgesics administered as bolus doses reduce the time receiving mechanical ventilation The study is planned as a randomised prospective study not blinded The control group is patients receiving sedation with daily wake up trials The intervention group is not sedated but receives bolus doses of analgesics morphine The endpoint is the time spend receiving mechanical ventilation lengths of stay on the intensive care unit and total lengths of stay on the hospital
We also examine the frequency of ventilator associated pneumonia and CT scans of cerebrum Also we would like to examine the long term psychological effects of sedation we plan to send some of the patients to a post traumatic stress screening The effect on the next of kin we plan to study with a questionnaire As a last thing we would like to study the workload on the nurses
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