Cerebral Arterial AneurysmNCT03185091
Neuromonitoring During Rapid Ventricular Pacing in Patients Undergoing Cerebral Aneurysm Surgery
A study testing rapid ventricular pacing and Surgery in people with Cerebral Arterial Aneurysm and Ventricular Rate Response Pacing, run by University Hospital, Antwerp at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Arterial Aneurysm, Ventricular Rate Response Pacing
- What is being tested?
- rapid ventricular pacing and Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteBelgium
- Study dates
- 14 Jan 2013to 1 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- scheduled for cerebral aneurysm surgery or arterial venous malformation
- American Society of Anesthesiologists classification 1, 2, or 3
Who cannot join
- non
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety of Rapid Ventricular Pacing During Cerebral Aneurysm Surgery by Multimodal Neuromonitoring
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.
Read the 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.
- Being tested
- rapid ventricular pacing, Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rapid ventricular pacingOther
SurgeryProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| rapid ventricular pacing | Other | Safety of rapid ventricular pacing during neurosurgical procedures Receives: Other: rapid ventricular pacing; Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During surgery
Cerebral blood flow during surgery
Thermal diffusion flowmetry measures the local absolute cerebral blood flow
Measured: During surgery
Secondary outcomes (3)
Electrophysiological changes in the brain during surgery
Electro-corticography measures electrophysiological changes in the brain.
Measured: During surgery
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.
Measured: 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
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.
Measured: Intraoperative (Start of hyperventilation until bloodgas analyses shows an arterial carbon dioxide pressure between 24 and 32 millimetre of mercury.)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start14 Jan 2013
- Primary completion11 Apr 2016
- Study completion1 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral Arterial AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ethisch.comite@uza.be, University Hospital, Antwerp
- Investigators
- Vera Saldien, MD, Principal investigator, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03185091
- Sponsor's protocol ID
- 12/50/410
- Status last verified
- Mar 2021
- First submitted
- 24 Jun 2015
- Last updated
- 30 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 21937926
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Rapid Ventricular Pacing During Cerebral Aneurysm Surgery by Multimodal Neuromonitoring
- ClinicalTrials.gov ID
- NCT03185091
- Acronym / sponsor ID
- 12/50/410
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Study start
- 14 Jan 2013 (actual)
- Primary completion
- 11 Apr 2016 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 14 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| rapid ventricular pacing | Other | Other: rapid ventricular pacing, Procedure: SurgerySafety of rapid ventricular pacing during neurosurgical procedures |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- scheduled for cerebral aneurysm surgery or arterial venous malformation
- American Society of Anesthesiologists classification 1, 2, or 3
Key exclusion criteria (1 listed)
- non
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rapid ventricular pacing | Other | rapid ventricular pacing |
| Surgery | Procedure or surgery | rapid ventricular pacing |
Primary outcome
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.
Cerebral blood flow during surgery
Time frame: During surgery
Thermal diffusion flowmetry measures the local absolute cerebral blood flow
3 secondary outcomes
Electrophysiological changes in the brain during surgery
Time frame: During surgery
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 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.)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2021.
- Background: PubMed 21937926Saldien 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vera Saldien, MD principal investigator
University Hospital, Antwerp
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rapid ventricular pacing and Surgery in people with Cerebral Arterial Aneurysm and Ventricular Rate Response Pacing, run by University Hospital, Antwerp at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebral oxygenation during surgery (time frame: During surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03185091, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2021.