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

Not Applicable

• Conditions: Subarachnoid Hemorrhage
• Interventions: Device: Cerebral oxymetry monitoring (NIRS)

• Registration Number: NCT04042571
• Lead Sponsor: University Hospital, Bordeaux

Brief 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.

Detailed 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 Timeline

• Study First Submitted: 2019-07-31
• Study First Submitted QC: 2019-07-31
• Study First Posted: 2019-08-02
• Study Start: 2019-10-01
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-30
• Last Update Posted: 2022-03-31
• Primary Completion: 2022-10-01
• Study Completion: 2022-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

• Men and women
• Age ≥ 18 years
• HSA of aneurysmal etiology less than 4 days before inclusion diagnosed by clinical presentation and emergency imaging
• HSA "severe" defined according to the WFNS ≥ III
• Intubated-ventilated patient or any other reason preventing a contributing neurological examination
• Affiliate or beneficiary of a social security scheme
• Free, informed and written consent signed by the representative

Exclusion Criteria

• Age <18 years
• Significant vasospasm as soon as the detection was detected on the initial imaging
• Possible Neurological Surveillance
• Intra-parenchymal frontal haematoma limiting the quality of measurement, diagnosed on imaging (Less than 25mm deep from the skin)
• Patient in limitation of active therapeutics or with high probability of soon limitation of active therapeutics
• Adhesive allergy to measuring patches
• Patient under guardianship or safeguard of justice
• Refusal of legal representative

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cerebral oxymetry monitoring (NIRS)	Cerebral oxymetry monitoring (NIRS)	Cerebral oxymetry (NIRS) -by rSO2 measurement - in order to detect vasospasm in patient with severe subarachnoid hemorrhage compare to standard monitoring tools

Primary Outcome Measures

Name	Time	Method
Permanent measurement of cerabral oxymetry (rSO2) by NIRS system	From day 4 to day 12 post aneurysmal subarachnoid hemorrhage	Difference between NIRS basal measurement entre la mesure basale du NIRS (NIRS average on the first hour of recording respectively on the left and right) and the NIRS measurement during the follow-up (lowest mean NIRS observed over one hour in patients without vasospasm diagnosed by the reference test or mean NIRS observed over the hour.

Secondary Outcome Measures

Name	Time	Method
Severity of angiographic spasm	Day 8 post aneurysmal subarachnoid hemorrhage	Not significant (\<50%) Significant (\>50%) Severe.
Pti02 value	Day 12 post aneurysmal subarachnoid hemorrhage	Pti02 value (mm Hg)

Trial Locations

Locations (1)

CHU de Bordeaux; 🇫🇷 Bordeaux, France