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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03185091
Other study ID # 12/50/410
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 14, 2013
Est. completion date December 1, 2017

Study information

Verified date March 2021
Source University Hospital, Antwerp
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

Patients scheduled for cerebral aneurysm clipping surgery or arteriovenous malformation surgery(ASA 1to 3 over 18years) receive standard care general anesthesia including central venous line for rapid ventricular pacing technique. A contralateral Foresight sensor is placed on the forehead of the patient at induction. After the craniotomy two micro electrodes(PBtO2 and cerebral blood flow) are placed in the brain and fixated. A subdural strip electrode is placed on the surface of the brain to record the electrical activity. Effect of mild hyperventilation and oxygenation with 100% O2 is evaluated.


Recruitment information / eligibility

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

Study Design


Intervention

Other:
rapid ventricular pacing

Procedure:
Surgery


Locations

Country Name City State
Belgium University Hospital Antwerp Edegem Antwerp

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Antwerp

Country where clinical trial is conducted

Belgium, 

References & Publications (1)

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

Outcome

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.)
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