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Neuromonitoring During Rapid Ventricular Pacing in Patients Undergoing Cerebral Aneurysm Surgery

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ClinicalTrials.gov Identifier: NCT03185091
Recruitment Status : Active, not recruiting
First Posted : June 14, 2017
Last Update Posted : June 19, 2017
Sponsor:
Information provided by (Responsible Party):
Ethisch Comité UZA, University Hospital, Antwerp

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.

Condition or disease Intervention/treatment Phase
Cerebral Arterial Aneurysm Ventricular Rate Response Pacing Other: rapid ventricular pacing Procedure: Surgery Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Safety of Rapid Ventricular Pacing During Cerebral Aneurysm Surgery by Multimodal Neuromonitoring
Actual Study Start Date : January 14, 2013
Actual Primary Completion Date : March 22, 2016
Estimated Study Completion Date : December 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms

Arm Intervention/treatment
rapid ventricular pacing
Safety of rapid ventricular pacing during neurosurgical procedures
Other: rapid ventricular pacing
Procedure: Surgery



Primary Outcome Measures :
  1. Cerebral oxygenation during surgery [ Time Frame: 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.

  2. Cerebral blood flow during surgery [ Time Frame: During surgery ]
    Thermal diffusion flowmetry measures the local absolute cerebral blood flow


Secondary Outcome Measures :
  1. Electrophysiological changes in the brain during surgery [ Time Frame: During surgery ]
    Electro-corticography measures electrophysiological changes in the brain.

  2. Effect of ventilation with 100 % oxygen on cerebral parameters after rapid ventricular pacing [ Time Frame: Intraoperative ( Start of ventilation at 100% oxygen until bloodgas analyses shows an increase in arterial oxygen pressure.) ]
    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.

  3. Effect of hyperventilation on cerebral parameters after rapid ventricular pacing [ Time Frame: Intraoperative (Start of hyperventilation until bloodgas analyses shows an arterial carbon dioxide pressure between 24 and 32 millimetre of mercury.) ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • scheduled for cerebral aneurysm surgery or arterial venous malformation
  • American Society of Anesthesiologists classification 1, 2, or 3

Exclusion Criteria:

  • non

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03185091


Locations
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Belgium
University Hospital Antwerp
Edegem, Antwerp, Belgium, 2650
Sponsors and Collaborators
University Hospital, Antwerp
Investigators
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Principal Investigator: Vera Saldien, MD University Hospital, Antwerp

Publications:
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Responsible Party: Ethisch Comité UZA, Principal Investigator, University Hospital, Antwerp
ClinicalTrials.gov Identifier: NCT03185091     History of Changes
Other Study ID Numbers: 12/50/410
First Posted: June 14, 2017    Key Record Dates
Last Update Posted: June 19, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Aneurysm
Intracranial Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases