Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00221520
Status:
UNKNOWN
Last Update Posted:
2007-01-11
First Post:
2005-09-15
Brief Title:
Sedation in the Intensive Care Unit
Sponsor:
University Hospital Geneva
Organization:
University Hospital Geneva
Study Overview
Official Title:
Trial on The Efficacy of Sedation in Mechanically Ventilated Critically Ill Patients
Status:
UNKNOWN
Status Verified Date:
2007-01
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
High-risk critically ill patients often require mechanical ventilation either to primarily support the respiratory function or when the ventilation is insufficient to maintain adequate gas exchanges as a result of other organ impairment In order to tolerate this aggressive mechanical support enhance patient synchrony with the ventilator and relieve pain and anxiety analgesia and sedation are provided It is suggested that an inappropriate use of sedation and analgesia may prolong the duration of mechanical ventilation and increase the risk of specific adverse outcomes such as ventilator associated pneumonia Despite the widespread use of sedation little information is available concerning the effect of varying the level of sedation on patients subsequent mental health We designed a randomized controlled trial to investigate the efficacy of sedation with the goal of maintaining the patient cooperative and interactive compared to the administration of sedation with the goal of maintaining the patient sedated The first goal will be achieved by a discontinuous injection of a sedative while the second goal will be achieved by a continuous infusion of the same sedative In both groups pain relief will be provided in the same fashion with equal endpoints on a pain scoring scale Our primary aim is to investigate whether differences in the occurrence of post-traumatic stress disorders PTSD anxiety and depression are related to the choice of sedation-analgesia strategies Secondary endpoints include the length of ICU stay as indicated by the time to discharge from the ICU the time to separation from mechanical ventilation the rates of pulmonary and extra-pulmonary complications and hospital length of stay These endpoints will be compared between the two groups
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2002DR2266 | None | None | None |