- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05213832
Effect of Inhalatory Sedation in Subarachnoid Hemorrhage (INSPIRE)
Effect of Inhalatory Sedation on Cerebral Perfusion in Subarachnoid Hemorrhage
The aim of this study is to evaluate the effect of inhalational sedation on cerebral perfusion in patients with SAH.
It will evaluate whether the administration of isofluorane, by inducing direct vasodilation in the cerebral parenchyma, can improve the cerebral perfusion rates.
Perfusional CT will be used to study the variation of cerebral blood flow to rule out the vasodilatory effect on territories with different cerebrovascular reactivity aggravating the phenomena of distrectual hypoperfusion (theft theory).
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
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Torino, Italy, 10126
- AOU Città della Salute e della Scienza - Presidio CTO
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age > 18 years old
- Diagnosis of non-traumatic SAH
- Neurological and/or systemic presentation that requires support of vital functions and sedation. This occurs for a WFNS score (World Federation of Neurosurgical Societies) ≥ 3.
- Possibility of ICP monitoring through EVD which is necessary in case of acute hydrocephalous. In case of the neurosurgeon do not indicate the positioning of the EVD, an intraparenchymal catheter will be positioned for the ICP monitoring.
- Patients with vasospasm (area of cerebral blood flow under 30% of the best value detected in the brain of the patients at the first CT scan). This exam will be performed at 2° - 3° day post event.
- Acceptance of informed consent.
Exclusion Criteria:
- Documented outcomes of cerebrovascular disease
- Patients with acute heart failure related to ESA
- State of pregnancy
- Patients with CLCR < 30 mL/min
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Inhalatory group
Patience with severe SAH (WFNS > 3) are enrolled in the study.
In these patients we administered a inhalatory dose of Isofluorane
|
Administration of isofluorane in patients with severe SAH
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cerebral blood flow recondtion
Time Frame: 20 minutes
|
The percentage of subjects who had a flow recondition at the second CT at least 50% of the best value detected in the first perfusion CT scan
|
20 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in intracranial pressure during isoflurane delivery
Time Frame: 20 minutes
|
We evaluate if isofluorane create an increase in ICP trough continuous monitoring.
|
20 minutes
|
Changes in blood pressure during isoflurane delivery
Time Frame: 20 minutes
|
By its vasodilatatore effect, we monitored punctually if mean arterial blood pressure will increase during isofluorane delivery
|
20 minutes
|
Collaborators and Investigators
Investigators
- Principal Investigator: Maurizio Berardino, MD, AOU Città della Salute e della Scienza
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Intracranial Hemorrhages
- Hemorrhage
- Subarachnoid Hemorrhage
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Anesthetics, General
- Anesthetics
- Anesthetics, Inhalation
- Isoflurane
Other Study ID Numbers
- 0076379
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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