INSPIRE: Effect of Inhalatory Sedation in Subarachnoid Hemorrhage

• Sponsor: Azienda Ospedaliera Città della Salute e della Scienza di Torino (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05213832
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 30.2
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Subarachnoid Hemorrhage; Aneurysmal Subarachnoid Hemorrhage	Drug: Isoflurane Inhal Soln	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Effect of Inhalatory Sedation on Cerebral Perfusion in Subarachnoid Hemorrhage
• Actual Study Start Date: Jun 26, 2020
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Dec 31, 2022

Arms and Interventions

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	Drug: Isoflurane Inhal Soln; Administration of isofluorane in patients with severe SAH

Outcome Measures

Primary Outcome Measures

1. Cerebral blood flow recondtion [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

Secondary Outcome Measures

1. Changes in intracranial pressure during isoflurane delivery [20 minutes]

   We evaluate if isofluorane create an increase in ICP trough continuous monitoring.

2. Changes in blood pressure during isoflurane delivery [20 minutes]

   By its vasodilatatore effect, we monitored punctually if blood pressure will increase during isofluorane delivery

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 64 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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) ≥

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AOU Città della Salute e della Scienza - Presidio CTO	Torino		Italy	10126

Sponsors and Collaborators

• Azienda Ospedaliera Città della Salute e della Scienza di Torino

Investigators

• Principal Investigator: Maurizio Berardino, MD, AOU Città della Salute e della Scienza

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Maurizio Berardino, Director of Anesthesia and Intensive Care Unit Departement, Azienda Ospedaliera Città della Salute e della Scienza di Torino
• ClinicalTrials.gov Identifier: NCT05213832
• Other Study ID Numbers: 0076379
• First Posted: Jan 28, 2022
• Last Update Posted: May 12, 2022
• Last Verified: May 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Maurizio Berardino, Director of Anesthesia and Intensive Care Unit Departement, Azienda Ospedaliera Città della Salute e della Scienza di Torino: perfusion; isofluorane; inhalatory; sedation
• Additional relevant MeSH terms: Subarachnoid Hemorrhage; Hemorrhage; Isoflurane

Study Results

No Results Posted as of May 12, 2022