CHU de Bordeaux
Bordeaux, 33 076, France
NCT Number: NCT04042571
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Bordeaux, 33 076, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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.
Time frame: Day 8 post aneurysmal subarachnoid hemorrhage
Not significant (<50%) Significant (>50%) Severe.
Time frame: Day 4 post aneurysmal subarachnoid hemorrhage
Pti02 value (mm Hg)
Time frame: Day 8 post aneurysmal subarachnoid hemorrhage
Pti02 value (mm Hg)
Time frame: Day 12 post aneurysmal subarachnoid hemorrhage
Pti02 value (mm Hg)
University Hospital, Bordeaux
Other
Acronym: COMOVA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT02894034
Brain Diseases, Cardiovascular Diseases
Amiens, France
View Trial DetailsNCT03655509
Brain Diseases, Cardiovascular Diseases
Rennes, France
View Trial DetailsNCT06797765
Brain Diseases, Cardiovascular Diseases
Dallas, Texas, United States
View Trial DetailsNCT00823485
Aneurysm, Aneurysm, Ruptured
Nice, France
View Trial Details