Intracranial Aneurysm, Surgical Clip
Conditions
Keywords
Intracranial Aneurysm, Surgical Clipping, Rapid Ventricular Pacing
Brief summary
Treatment of complex unruptured intracranial aneurysms (UIA) remains challenging to date. Therefore, advanced techniques are required to achieve an optimal result in treating these patients safely. In this study, the safety and efficacy of rapid ventricular pacing (RVP) to facilitate microsurgical clip-reconstruction has been studied prospectively in a joined neurosurgical, anesthesiological and cardiological study.
Detailed description
Treatment of complex unruptured intracranial aneurysms (UIA) remains challenging to date. Therefore, advanced techniques are required to achieve an optimal result in treating these patients safely. In this study, the safety and efficacy of rapid ventricular pacing (RVP) to facilitate microsurgical clip-reconstruction has been studied prospectively in a joined neurosurgical, anesthesiological and cardiological study. Patients with complex UIA were prospectively enrolled and the safety and efficacy of RVP were evaluated recording cardiovascular events and outcome of the patients as well as the amount of aneurysm occlusion after the surgical clip-reconstruction procedure.
Interventions
PROCEDURERapid Ventricular Pacing
Use of Rapid Ventricular Pacing to improve surgical clipping of intracranial aneurysms
Sponsors
University Clinic Frankfurt
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* complex UIA intended to be treated by microsurgical clip-reconstruction * application of RVP intra-operatively
Exclusion criteria
* structural heart disease or conductance abnormalities
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| modified Rankin scale | 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of flow reduction and improvement of clip application | intraoperatively | Efficacy of flow reduction (failure rate of pacing; measuring of heart rate and blood pressure). Also improvement of clip application: performing surgeon has to complete a questionnaire. |
| safety of pacing catheter | intraoperatively upt o 24 hours after operation | Complications during insertion, positioning, application (intraoperatively) and removal of pacing catheter (postoperatively on ICU). Anesthesiologist has to complete a questionnaire. |
| Cardiovascular events | intraoperatively upt o 24 hours after operation | All cardiovascular events will be documented (like arrhythmias etc.). Also preoperative heart values (of Troponin T, CK, CK-MB) and values after operation and one day after operation will be documented and afterwards analyzed. Reference values (05/2016): CK \<190 U/l; CK-MB \<24 U/l; Troponin T \<14pg/ml Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment were documented and analyzed. |
| occlusion rate of aneurysm | 1 week after operation | Angiography to control the occlusion of the aneurysm, regularly 1 week after surgical clipping. |
Countries
Germany
Contacts
Primary ContactAnne Sicking
Outcome results
None listed