- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05567341
Remote Ischemic Preconditioning in Vestibular Schwannoma Surgery (RIC-VS)
Remote Ischemic Preconditioning in Vestibular Schwannoma Surgery and Its Neuroprotective Effect on the Cochlear and Facial Nerve Function
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Purpose: Does remote ischemic preconditioning improve hearing and/or facial nerve palsy after resection of vestibular schwannomas?
Study Design: Prospective, randomized, double-blind, single-center.
Case number: The study should include 120 patients (60 treatment arm, 60 control arm). Case number calculation (mean effect sizes, chi-square test, alpha error = 0.05, beta error = 20%) results in a necessary total patient number of 100 with 50 patients per group. Including the expected dropout rate (approx. 20%), the required total number of study participants is set at 120 patients. With approximately 55 patients/year in whom anatomic preservation of the cochlear nerve is possible intraoperatively, the total study duration is estimated to be approximately 2-2.5 years.
Study procedure: Day 1
- Preoperative pure tone audiometry including speech discrimination and preoperative AEP measurement
- preoperative assessment of facial nerve function according to House and Brackmann and photo documentation
- Preoperative blood sample (Hg, WBC, platelet count, creatinine, sodium, potassium, CRP, PCT, IL-6, INR, Quick, aPTT, d-dimer)
- Evaluation of inclusion and exclusion criteria, informed consent
Day 2
- Randomization
At skin incision RIC procedure or sham control.
- RIC arm: 5 minutes inflation of a blood pressure cuff to 200mmHg on the right arm, then 5 minutes rest, the procedure will be performed 4 times in total.
- Control arm: 5 minutes inflation of a blood pressure cuff to 0mmHg on the right arm, then 5 minutes rest, the procedure will be performed 4 times in total.
- Performance of tumor resection under electrophysiological monitoring.
- blood sample (Hg, WBC, platelet count, creatinine, sodium, potassium, CRP, PCT, IL-6, INR, Quick, aPTT, d-dimer)
Day 3
- blood sample (Hg, WBC, platelet count, creatinine, sodium, potassium, CRP, PCT, IL-6, INR, Quick, aPTT, d-dimer)
- Clinical assessment of facial nerve function
- Evaluation of complications
Before discharge
- Clinical assessment of facial nerve function and photo documentation
- Evaluation of complications occurring in the course of the procedure
- Postoperative AEP measurement and pure tone audiometry incl. speech discrimination
Outpatient follow-up after 3 months
- Evaluation of postoperative pure tone audiometry incl. speech discrimination
- Clinical assessment of facial nerve function and photo documentation
Objective:
Primary outcome: patients undergoing RIC will show better hearing 3 months postoperatively than the sham control group.
Secondary outcome hypothesis: patients undergoing RIC will show better postoperative facial nerve function than the sham control group before discharge and 3 months postoperatively.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Helene V Hurth, MD
- Phone Number: +49 7071 29 80325
- Email: helene.hurth@med.uni-tuebingen.de
Study Contact Backup
- Name: Constantin Roder, Prof., MD
- Email: constantin.roder@med.uni-tuebingen.de
Study Locations
-
-
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Tuebingen, Germany, 72076
- University Hospital Tuebingen
-
Contact:
- Helene V Hurth, MD
- Phone Number: +49 7071 29 80325
- Email: helene.hurth@med.uni-tuebingen.de
-
Contact:
- Constantin Roder, Prof., MD
- Email: constantin.roder@med.uni-tuebingen.de
-
Principal Investigator:
- Constantin Roder, Prof., MD
-
Sub-Investigator:
- Helene V Hurth, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age ≥ 18 years
- total or gross-total resection of a vestibular schwannoma is planned
- Functional hearing is still present on the affected side preoperatively (AEP evocable and Gardner-Robertson grade I, II, or III).
- Preoperatively, facial function is unimpaired or mildly impaired (House and Brackmann grade I or II).
Exclusion Criteria:
- Symptomatic peripheral artery disease.
- Active or previous thrombosis in the extremity where the RIC procedure is to be performed.
- Neurofibromatosis type 2
- Only planned decompression of the internal auditory canal without relevant tumor resection
- Pregnant or breastfeeding females
- Previous radiotherapy of the vestibular schwannoma that will be resected
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: RIC
On the right upper extremity a blood pressure cuff is inflated to 200mmHg for 4x5min at the beginning of the surgery
|
A blood pressure cuff is inflated to 200 mmHg for 4x5 min (5 min rest between cycles) at the right upper extremity when the vestibular schwannoma surgery is started
|
Sham Comparator: Control
On the right upper extremity a blood pressure cuff is inflated to 0mmHg for 4x5min at the beginning of the surgery
|
A blood pressure cuff is inflated to 0 mmHg for 4x5 min (5 min rest between cycles) at the right upper extremity when the vestibular schwannoma surgery is started
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
postoperative hearing
Time Frame: 3 months (± 6 weeks) after surgery
|
hearing on pure tone audiometry according to AAO-HNS/Gardner-Robertson
|
3 months (± 6 weeks) after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
postoperative facial nerve function
Time Frame: up to 8 days after surgery
|
facial nerve function according to House and Brackmann
|
up to 8 days after surgery
|
postoperative facial nerve function
Time Frame: 3 months (± 6 weeks) after surgery
|
facial nerve function according to House and Brackmann
|
3 months (± 6 weeks) after surgery
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
postoperative hearing
Time Frame: up to 8 days after surgery
|
hearing on pure tone audiometry according to AAO-HNS/Gardner-Robertson
|
up to 8 days after surgery
|
laboratory findings
Time Frame: within 4 hours after surgery
|
White blood count
|
within 4 hours after surgery
|
laboratory findings
Time Frame: within 4 hours after surgery
|
C-reactive protein
|
within 4 hours after surgery
|
laboratory findings
Time Frame: within 4 hours after surgery
|
Procalcitonin
|
within 4 hours after surgery
|
laboratory findings
Time Frame: within 4 hours after surgery
|
Interleukin 6
|
within 4 hours after surgery
|
laboratory findings
Time Frame: within 4 hours after surgery
|
D-Dimer
|
within 4 hours after surgery
|
laboratory findings
Time Frame: within 4 hours after surgery
|
platelet count
|
within 4 hours after surgery
|
laboratory findings
Time Frame: within 4 hours after surgery
|
International normalized ratio (INR)
|
within 4 hours after surgery
|
laboratory findings
Time Frame: within 4 hours after surgery
|
activated partial thromboplastin time (aPTT)
|
within 4 hours after surgery
|
laboratory findings
Time Frame: postoperatively, 1 day after surgery
|
White blood count
|
postoperatively, 1 day after surgery
|
laboratory findings
Time Frame: postoperatively, 1 day after surgery
|
C-reactive protein
|
postoperatively, 1 day after surgery
|
laboratory findings
Time Frame: postoperatively, 1 day after surgery
|
Procalcitonin
|
postoperatively, 1 day after surgery
|
laboratory findings
Time Frame: postoperatively, 1 day after surgery
|
Interleukin 6
|
postoperatively, 1 day after surgery
|
laboratory findings
Time Frame: postoperatively, 1 day after surgery
|
D-Dimer
|
postoperatively, 1 day after surgery
|
laboratory findings
Time Frame: postoperatively, 1 day after surgery
|
platelet count
|
postoperatively, 1 day after surgery
|
laboratory findings
Time Frame: postoperatively, 1 day after surgery
|
International normalized ratio (INR)
|
postoperatively, 1 day after surgery
|
laboratory findings
Time Frame: postoperatively, 1 day after surgery
|
activated partial thromboplastin time (aPTT)
|
postoperatively, 1 day after surgery
|
postoperative AEP
Time Frame: up to 8 days after surgery
|
Auditory evoked potentials after surgery
|
up to 8 days after surgery
|
postoperative vertigo
Time Frame: up to 8 days after surgery
|
Vertigo according to dizziness handicap inventory (=DHI, score 0-100, higher scores are associated with a higher burden of dizziness)
|
up to 8 days after surgery
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postoperative vertigo
Time Frame: 3 months (± 6 weeks) after surgery
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Vertigo according to dizziness handicap inventory (=DHI, score 0-100, higher scores are associated with a higher burden of dizziness)
|
3 months (± 6 weeks) after surgery
|
extent of schwannoma resection
Time Frame: 3 months (± 6 weeks) after surgery
|
extent of schwannoma resection on the postoperative MRI
|
3 months (± 6 weeks) after surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Contantin Roder, Prof., MD, Department of Neurosurgery Tuebingen
- Principal Investigator: Helene V Hurth, MD, Department of Neurosurgery Tuebingen
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Otorhinolaryngologic Neoplasms
- Otorhinolaryngologic Diseases
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Ear Diseases
- Nervous System Neoplasms
- Cranial Nerve Diseases
- Neuroendocrine Tumors
- Nerve Sheath Neoplasms
- Peripheral Nervous System Neoplasms
- Cranial Nerve Neoplasms
- Neuroma
- Vestibulocochlear Nerve Diseases
- Retrocochlear Diseases
- Neurilemmoma
- Neuroma, Acoustic
Other Study ID Numbers
- 489-0-0
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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