Remote Ischemic Preconditioning in Vestibular Schwannoma Surgery

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Remote Ischemic Preconditioning in Vestibular Schwannoma Surgery

Study Purpose

Vestibular schwannomas are primarily benign (WHO grade I) tumors originating from the Schwann cells of the vestibular nerve and are among the most common tumors of the skull base. Common treatment options are surgical tumor resection or targeted radiation therapy. The special challenge of surgical treatment is the functional preservation of the cranial nerves, especially the cochlear and facial nerves. Perioperative ischemia of the cochlea and cochlear nerve is postulated as the underlying mechanism of postoperative hearing loss. Ischemic preconditioning is a non-invasive procedure that triggers the release of vasoactive cytokines and mediators by repeated short-term induction of limb ischemia. Improved perfusion of critically perfused end organs as well as a reduction of cerebral infarct volumes has already been shown in other pathologies. In the planned study, possible neuroprotective effects of remote ischemic preconditioning on postoperative hearing as well as facial nerve function in patients with vestibular schwannomas will be examined.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05567341
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University Hospital Tuebingen
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Contantin Roder, Prof., MDHelene V Hurth, MD
Principal Investigator Affiliation	Department of Neurosurgery TuebingenDepartment of Neurosurgery Tuebingen
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries	Germany
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Vestibular Schwannoma

Additional Details

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.

Arms & Interventions

Arms

Experimental: RIC

On the right upper extremity a blood pressure cuff is inflated to 200mmHg for 4x5min at the beginning of the surgery

Sham Comparator: Control

On the right upper extremity a blood pressure cuff is inflated to 0mmHg for 4x5min at the beginning of the surgery

Interventions

Procedure: - Remote ischemic preconditioning

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

Procedure: - Sham-control

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

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