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Effect of Inhalatory Sedation in Subarachnoid Hemorrhage (INSPIRE)

Primary Purpose

Subarachnoid Hemorrhage, Aneurysmal Subarachnoid Hemorrhage

Status

Recruiting

Phase

Phase 2

Locations

Italy

Study Type

Interventional

Intervention

Isoflurane Inhal Soln

About this trial

This is an interventional supportive care trial for Subarachnoid Hemorrhage focused on measuring perfusion, isofluorane, inhalatory, sedation

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

AOU Città della Salute e della Scienza - Presidio CTORecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Inhalatory group

Arm Description

Patience with severe SAH (WFNS > 3) are enrolled in the study. In these patients we administered a inhalatory dose of Isofluorane

Outcomes

Primary Outcome Measures

Cerebral blood flow recondtion

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

Changes in intracranial pressure during isoflurane delivery

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

Changes in blood pressure during isoflurane delivery

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

Full Information

NCT ID

NCT05213832

First Posted

January 16, 2022

Last Updated

November 3, 2022

Sponsor

Azienda Ospedaliera Città della Salute e della Scienza di Torino

1. Study Identification

Unique Protocol Identification Number

NCT05213832

Brief Title

Effect of Inhalatory Sedation in Subarachnoid Hemorrhage

Acronym

INSPIRE

Official Title

Effect of Inhalatory Sedation on Cerebral Perfusion in Subarachnoid Hemorrhage

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Recruiting

Study Start Date

June 26, 2020 (Actual)

Primary Completion Date

December 31, 2022 (Anticipated)

Study Completion Date

December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Azienda Ospedaliera Città della Salute e della Scienza di Torino

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Subarachnoid Hemorrhage, Aneurysmal Subarachnoid Hemorrhage

Keywords

perfusion, isofluorane, inhalatory, sedation

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Inhalatory group

Arm Type

Experimental

Arm Description

Patience with severe SAH (WFNS > 3) are enrolled in the study. In these patients we administered a inhalatory dose of Isofluorane

Intervention Type

Drug

Intervention Name(s)

Isoflurane Inhal Soln

Intervention Description

Administration of isofluorane in patients with severe SAH

Primary Outcome Measure Information:

Title

Cerebral blood flow recondtion

Description

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

Time Frame

20 minutes

Secondary Outcome Measure Information:

Title

Changes in intracranial pressure during isoflurane delivery

Description

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

Time Frame

20 minutes

Title

Changes in blood pressure during isoflurane delivery

Description

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

Time Frame

20 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Maurizio Berardino, MD

Phone

+393460160346

mberardino@cittadellasalute.to.it

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Maurizio Berardino, MD

Organizational Affiliation

AOU Città della Salute e della Scienza

Official's Role

Principal Investigator

Facility Information:

Facility Name

AOU Città della Salute e della Scienza - Presidio CTO

City

Torino

ZIP/Postal Code

10126

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Maurizio Berardino, MD

Phone

01169333818

mberardino@cittadellaslaute.to.it

First Name & Middle Initial & Last Name & Degree

Maurizio Berardino, MD

First Name & Middle Initial & Last Name & Degree

Ilaria Depetris, MD

First Name & Middle Initial & Last Name & Degree

Alice Mistretta, MD

First Name & Middle Initial & Last Name & Degree

Maria Maddalena Ferraris, MD

First Name & Middle Initial & Last Name & Degree

Giuseppe Di Perna, MD

First Name & Middle Initial & Last Name & Degree

Maria Cristina Auguiari, Nurse

12. IPD Sharing Statement

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Effect of Inhalatory Sedation in Subarachnoid Hemorrhage

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