Neuromonitoring During Rapid Ventricular Pacing in Patients Undergoing Cerebral Aneurysm Surgery
Safety of Rapid Ventricular Pacing During Cerebral Aneurysm Surgery by Multimodal Neuromonitoring
1 other identifier
interventional
7
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 14, 2013
CompletedFirst Submitted
Initial submission to the registry
June 24, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 11, 2016
CompletedFirst Posted
Study publicly available on registry
June 14, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedMarch 30, 2021
March 1, 2021
3.2 years
June 24, 2015
March 29, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
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
Cerebral blood flow during surgery
Thermal diffusion flowmetry measures the local absolute cerebral blood flow
During surgery
Secondary Outcomes (3)
Electrophysiological changes in the brain during surgery
During surgery
Effect of ventilation with 100 % oxygen on cerebral parameters after rapid ventricular pacing
Intraoperative ( Start of ventilation at 100% oxygen until bloodgas analyses shows an increase in arterial oxygen pressure.)
Effect of hyperventilation on cerebral parameters after rapid ventricular pacing
Intraoperative (Start of hyperventilation until bloodgas analyses shows an arterial carbon dioxide pressure between 24 and 32 millimetre of mercury.)
Study Arms (1)
rapid ventricular pacing
OTHERSafety of rapid ventricular pacing during neurosurgical procedures
Interventions
Eligibility Criteria
You may qualify if:
- scheduled for cerebral aneurysm surgery or arterial venous malformation
- American Society of Anesthesiologists classification 1, 2, or 3
You may not qualify if:
- non
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Antwerp
Edegem, Antwerp, 2650, Belgium
Related 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.
PMID: 21937926BACKGROUND
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Vera Saldien, MD
University Hospital, Antwerp
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 24, 2015
First Posted
June 14, 2017
Study Start
January 14, 2013
Primary Completion
April 11, 2016
Study Completion
December 1, 2017
Last Updated
March 30, 2021
Record last verified: 2021-03