Cerebral Arterial Aneurysm Clinical Trial
Official title:
Safety of Rapid Ventricular Pacing During Cerebral Aneurysm Surgery by Multimodal Neuromonitoring
Verified date | March 2021 |
Source | University Hospital, Antwerp |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To evaluate the effect of rapid ventricular pacing on the oxygenation of the brain in patients scheduled for cerebral aneurysm clipping surgery or arteriovenous malformation surgery.
Status | Completed |
Enrollment | 7 |
Est. completion date | December 1, 2017 |
Est. primary completion date | April 11, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - scheduled for cerebral aneurysm surgery or arterial venous malformation - American Society of Anesthesiologists classification 1, 2, or 3 Exclusion Criteria: - non |
Country | Name | City | State |
---|---|---|---|
Belgium | University Hospital Antwerp | Edegem | Antwerp |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Antwerp |
Belgium,
Saldien V, Menovsky T, Rommens M, Van der Steen G, Van Loock K, Vermeersch G, Mott C, Bosmans J, De Ridder D, Maas AI. Rapid ventricular pacing for flow arrest during cerebrovascular surgery: revival of an old concept. Neurosurgery. 2012 Jun;70(2 Suppl Operative):270-5. doi: 10.1227/NEU.0b013e318236d84a. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cerebral oxygenation during surgery | Oxygenation of the brain is measured by near-infrared spectroscopy and by evaluation of the brain tissue oxygen pressure by two microelectrodes placed in the brain. | During surgery | |
Primary | Cerebral blood flow during surgery | Thermal diffusion flowmetry measures the local absolute cerebral blood flow | During surgery | |
Secondary | Electrophysiological changes in the brain during surgery | Electro-corticography measures electrophysiological changes in the brain. | During surgery | |
Secondary | Effect of ventilation with 100 % oxygen on cerebral parameters after rapid ventricular pacing | Effect of ventilation with 100% oxygen on cerebral blood flow and cerebral tissue oxygenation measured by thermal diffusion flowmetry and brain tissue oxygen pressure measured by microelectrodes placed in the brain in combination with near-infrared spectroscopy, respectively. | Intraoperative ( Start of ventilation at 100% oxygen until bloodgas analyses shows an increase in arterial oxygen pressure.) | |
Secondary | Effect of hyperventilation on cerebral parameters after rapid ventricular pacing | Effect of hyperventilation (defined as arterial carbon dioxide pressure between 24 and 32 millimeter mercury) on cerebral blood flow and cerebral tissue oxygenation measured by thermal diffusion flowmetry and brain tissue oxygen pressure measured by microelectrodes placed in the brain in combination with near-infrared spectroscopy, respectively. | Intraoperative (Start of hyperventilation until bloodgas analyses shows an arterial carbon dioxide pressure between 24 and 32 millimetre of mercury.) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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