Rapid Ventricular Pacing During Cerebral Aneurysm Surgery: a Retrospective Study Concerning the Safety for Heart and Brain

NCT ID: NCT03281395

Last Updated: 2017-09-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 27 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-08-30
• Study Completion Date: 2013-07-15

Brief Summary

Rapid ventricular pacing (RVP) is a technique to obtain flow arrest for short periods of time during dissection or rupture of the aneurysm. RVP results in an adequate fall of blood pressure which presents as an on-off phenomenon. It is not clear whether repetitive periods of pacing are harmless for the patient. Silent cardiac and cerebral infarcts may be undetected. The investigator will study the safety of RVP, particularly for the heart and the brain, retrograde by studying troponin levels and magnetic resonance imaging or computed tomography.

Detailed Description

Rapid ventricular pacing (RVP) is a technique to obtain flow arrest for short periods of time during dissection or rupture of the aneurysm. RVP results in an adequate fall of blood pressure which presents as an on-off phenomenon. The technique facilitates the dissection and manipulation of cerebral aneurysms and arteriovenous malformations (AVMs) and can be lifesaving in the case of an intraoperative bleeding or rupture. In a former study blood pressure and clinical outcome were used as study parameters. However it is not clear whether repetitive periods of pacing are harmless for the patient. Silent cardiac and cerebral infarcts may be undetected if only clinical outcome is taken as a study parameter. In this retrograde study, the investigators will study the safety of RVP, particularly for the heart and the brain, using magnetic resonance imaging or computed tomography and troponin levels. The purpose of this study is to evaluate the effect of repetitive periods of RVP on the oxygenation of the heart and brain using magnetic resonance imaging and troponin levels both markers for ischemia damage.

Conditions

Cardiac Pacing, Artificial; Aneurysm, Brain; Arteriovenous Malformations, Cerebral

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

Cerebral aneurysm surgery with RVP

During surgery patients allocated to this group will undergo RVP. Subjects receive Magnetic Resonance Imaging or Computed Tomography as standard of care, pre-and postoperatively. To screen for rapid ventricular pacing induced micro-infarcts, the contralateral hemisphere(contralateral to the hemisphere operated on) and fossa posterior will be evaluated. Troponin levels are determinated preoperatively and 24 hours postoperatively by blood sample as standard of care. Maximum cTnl level and cTnl level 24 hours will be compared.

Rapid ventricular pacing (RVP)

Intervention Type: PROCEDURE

Rapid ventricular pacing (RVP) is a technique to obtain flow arrest for short period of time during dissection of the aneurysm. RVP results in an adequate fall in blood pressure which presents as an on-off phenomenon. RVP technique facilitates the dissection and manipulation of cerebral aneurysms and arteriovenous malformations and can be lifesaving in the case of an intraoperative bleeding or rupture.

Craniotomy without RVP

No rapid ventricular pacing is applied during surgery. Subjects receive Magnetic Resonance Imaging or Computed Tomography as standard of care, pre-and postoperatively. To screen for induced micro-infarcts, the contralateral hemisphere(contralateral to the hemisphere operated on) and fossa posterior will be evaluated. Troponin levels are determinated preoperatively and 24 hours postoperatively by blood sample as standard of care. Maximum cTnl level and cTnl level 24 hours will be compared.

No rapid ventricular pacing

Intervention Type: PROCEDURE

Interventions

Rapid ventricular pacing (RVP)

Rapid ventricular pacing (RVP) is a technique to obtain flow arrest for short period of time during dissection of the aneurysm. RVP results in an adequate fall in blood pressure which presents as an on-off phenomenon. RVP technique facilitates the dissection and manipulation of cerebral aneurysms and arteriovenous malformations and can be lifesaving in the case of an intraoperative bleeding or rupture.

Intervention Type: PROCEDURE

No rapid ventricular pacing

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• elective cerebral aneurysm clipping surgery
• arteriovenous malformation surgery
• craniotomy
• American Society of Anesthesiologists 1,2 and 3

Exclusion Criteria

• cardiac abnormalities
• coronary heart disease
• valvular heart disease
• pregnancy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Antwerp

OTHER

Sponsor Role: lead

Responsible Party

Joke De Wachter

data manager

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vera Saldien, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Antwerp

Tomas Menovsky, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Antwerp

Locations

University hospital Antwerp

Edegem, Antwerp, Belgium

Countries

Belgium

Other Identifiers

17/16/205-2

Identifier Type: -

Identifier Source: org_study_id