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

Subarachnoid Hemorrhage Clinical Trial

— COMOVA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04042571
• Other study ID #: CHUBX 2015/34
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: October 1, 2022

Study information

• Verified date: March 2022
• Source: University Hospital, Bordeaux
• Contact: Gaultier Marnat
• Phone: 05 56 79 48 80
• Email: gaultier.marnat[@]chu-bordeaux.fr
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 88
• Est. completion date: October 1, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Subarachnoid Hemorrhage

Intervention

Device:
• Cerebral oxymetry monitoring (NIRS)
Near-InfraRed Spectroscopy (NIRS) is a non-invasive method measuring tissue oxygenation by regional saturation of capillary-oxygenated hemoglobin (rSO2). Starting on day 4 after aneurismal rupture NIRS electrods will be placed and maintained until day 12 permanently and blindly recording rSO2. Patients will be monitored following daily practice recommandations inclunding vasospasm detection and treatment.

Locations

Country	Name	City	State
France	CHU de Bordeaux	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Permanent measurement of cerabral oxymetry (rSO2) by NIRS system	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.	From day 4 to day 12 post aneurysmal subarachnoid hemorrhage
Secondary	Severity of angiographic spasm	Not significant (<50%) Significant (>50%) Severe.	Day 8 post aneurysmal subarachnoid hemorrhage
Secondary	Pti02 value	Pti02 value (mm Hg)	Day 4 post aneurysmal subarachnoid hemorrhage
Secondary	Pti02 value	Pti02 value (mm Hg)	Day 8 post aneurysmal subarachnoid hemorrhage
Secondary	Pti02 value	Pti02 value (mm Hg)	Day 12 post aneurysmal subarachnoid hemorrhage