Permanent Cerebral Oxymetry Monitoring for Early Diagnosis & Treatment of

Status Recruiting

Clinical Trial Summary

Transcranial Doppler ultrasound (TCD) monitoring and CT-scanner perfusion are useful but imperfect tools to identify vasospasm and allow intervention to avoid infarction. Permanent monitoring of cerebral tissue oximetry (rSO2) by NIRS, a noninvasive method could allow better vasospasm detection. This study will evaluate diagnostic accuracy of cerebral oxymetry (NIRS) -by rSO2 measurement - in order to detect vasospasm in patient with severe subarachnoid hemorrhage compare to standard monitoring tools.

Clinical Trial Description

Delayed vasospasm is a serious complication of aneurismal subarachnoid haemorhage (SAH) significantly influencing morbidity and mortality. Mostly observed between days 4 and 10 after aneurismal rupture, its incidence is higher in cases of severe SAH. Vasospasm strongly affects prognisis generating delayed cerebral ischemia. Clinical deterioration (focal neurological deficit) is the best way to detect severe vasospasm. Unfortunately, most of severe SAH are intubated and sedated prohibiting neurological evaluation. In these frequent situations, Transcranial Doppler (TCD), clinical and biological monitoring, CT-scanner (angio-CT and Perfusion-CT), MRI and cerebral angiography are routinely used to detect vasospasm. Yet, these tools have imperfect sensitivity and specificty delaying diagnosis and treatment. Near-InfraRed Spectroscopy (NIRS) is a non-invasive method measuring tissue oxygenation by regional saturation of capillary-oxygenated hemoglobin (rSO2). This technology demonstrated ability to measure cerebral oxygenation and has previously been reported to monitor carotid and pediatric surgery. To date a few studies also reported NIRS monitoring feasability in post-SAH vasospasm. Our aim is here to evaluate NIRS monitoring for the diagnosis of vasospasm in severe SAH. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04042571
Study type	Interventional
Source	University Hospital, Bordeaux
Contact	Gaultier Marnat
Phone	05 56 79 48 80
Email	gaultier.marnat@chu-bordeaux.fr
Status	Recruiting
Phase	N/A
Start date	October 1, 2019
Completion date	October 1, 2022

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT06043167` - Clinimetric Application of FOUR Scale as in Treatment and Rehabilitation of Patients With Acute Cerebral Injury
Recruiting	`NCT04189471` - Recovery After Cerebral Hemorrhage
Completed	`NCT03281590` - Stroke and Cerebrovascular Diseases Registry
Completed	`NCT05131295` - Dapsone Use in Patients With Aneurysmal Subarachnoid Hemorrhage.	Phase 3
Recruiting	`NCT02962349` - TRansfusion Strategies in Acute Brain INjured Patients	N/A
Completed	`NCT02872857` - Subarachnoid Hemorrhage Recovery And Galantamine	Phase 1/Phase 2
Terminated	`NCT02216513` - Deferoxamine to Prevent Delayed Cerebral Ischemia After Subarachnoid Hemorrhage	Phase 0
Completed	`NCT03164434` - Influence of Drainage on EVD ICP-signal
Completed	`NCT02389634` - Identification of Novel Molecular Markers for Vasospasm
Not yet recruiting	`NCT00905931` - Lycopene Following Aneurysmal Subarachnoid Haemorrhage	Phase 2
Completed	`NCT01077206` - High-dose Simvastatin for Aneurysmal Subarachnoid Haemorrhage	Phase 2/Phase 3
Completed	`NCT00962546` - Computed Tomographic (CT) Perfusion and CT Angiography as Screening Tools for Vasospasm Following Subarachnoid Hemorrhage	N/A
Completed	`NCT01261091` - Early Tracheostomy in Ventilated Stroke Patients	N/A
Completed	`NCT00507104` - Pituitary Functions After Traumatic Brain Injury (TBI) and/or Subarachnoid Hemorrhage (SAH)
Completed	`NCT00071565` - Familial Intracranial Aneurysm Study II	N/A
Recruiting	`NCT05113381` - The Purpose of This Study is to Determine Whether CerebroFlo™ EVD Catheter is Effective During the Treatment of IVH	N/A
Completed	`NCT04052646` - Prehospital Deaths From Spontaneous Subarachnoid Haemorrhages
Recruiting	`NCT04548596` - NOninVasive Intracranial prEssure From Transcranial doppLer Ultrasound Development of a Comprehensive Database of Multimodality Monitoring Signals for Brain-Injured Patients
Recruiting	`NCT06033378` - Blood Pressure Treatment in ICU Patients With Subarachniodal Haemorrhage.	N/A
Completed	`NCT04308577` - Diet Induced Ketosis for Brain Injury - A Feasibility Study	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Permanent Cerebral Oxymetry Monitoring for Early Diagnosis and Treatment of Delayed Vasospasm After Subarachnoid Hemorrhage — COMOVA

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms