Ignite Creation Date:
2024-05-06 @ 9:17 AM
Last Modification Date:
2024-10-26 @ 12:12 PM
Study NCT ID:
NCT02946437
Status:
WITHDRAWN
Last Update Posted:
2020-06-02
First Post:
2016-10-07
Brief Title:
Sevoflurane in Subarachnoidal Haemorrhage
Sponsor:
University of Zurich
Organization:
University of Zurich
Study Overview
Official Title:
Short Term Application of Sevoflurane in Patients With Subarachnoid Haemorrhage a Feasibility and Safety Study
Status:
WITHDRAWN
Status Verified Date:
2020-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Patients failed to be enrolled because of tight exclusion criteria
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Sevoflurane
Brief Summary:
Feasibility and safety of short term application of sevoflurane in patients with SAH treated with aneurysm coiling or clipping in the setting of a neurointensive care unit
Detailed Description:
After admission to the ICU before the coiling clipping intervention has been performed the patients are screened for eligibility When the patients are coming back to the ICU after successful aneurysm coiling or clipping data of artificial ventilation systemic and other cerebral parameters will be collected continuously by online monitoring starting at baseline and stopping at discharge of the ICU Sevoflurane will be vaporized and administrated by the MIRUSSystem directly to the inspiratory part of the ventilation circuit for the next 4 hours In the following 14 days of the stay on the ICU standard monitoring parameters the appearance of vasospasm and brain oedema will be recorded Besides the continuous online monitoring laboratory assessment will be performed daily At day 72 and day 142 after bleeding a MRI or CT examination will be performed according to the clinical condition of the patient to detect secondary brain injuries as ischemia or brain oedema At ICU discharge the neurological outcome will be assesses applying GOS
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 |
|---|---|---|---|
| 2015DR2134 | OTHER | Swissmedic | None |