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

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 200 mmHg for 4x5 min (5 min rest between cycles) at the right upper extremity when the vestibular schwannoma surgery is started

Remote ischemic preconditioning

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

Sham-control

Helene V Hurth, MD

Constantin Roder, Prof., MD

Contantin Roder, Prof., MD

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.

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.

group 1: intervention, remote ischemic preconditioning for 4x5 minutes at the beginning of the surgery group 2: sham-control (4x5 min without compression of the extremity)

only the study nurse who performs the intervention is aware of the study arm

Remote Ischemic Preconditioning in Vestibular Schwannoma Surgery

Remote Ischemic Preconditioning in Vestibular Schwannoma Surgery and Its Neuroprotective Effect on the Cochlear and Facial Nerve Function

IPD may be shared on request after completion of the study and as soon as data will be published.

hearing on pure tone audiometry according to AAO-HNS/Gardner-Robertson

activated partial thromboplastin time (aPTT)

Vertigo according to dizziness handicap inventory (=DHI, score 0-100, higher scores are associated with a higher burden of dizziness)

extent of schwannoma resection on the postoperative MRI

facial nerve function according to House and Brackmann

University Hospital Tuebingen

Hearing Loss

Deafness

Hearing Disorders

Sensation Disorders

Neurologic Manifestations

Electrical stimulation of the cochlear nerve will be tested intraoperatively in patients undergoing vestibular schwannoma resection.

Intraoperative electrical stimulation of the cochlear nerve in patients undergoing surgery for resection of vestibular schwannoma. Activation of the auditory system monitored with scalp recording of auditory brainstem response.

Electrical stimulation of cochlear nerve

Harrison W Lin, MD

John C Middlebrooks, PhD

Harrison M Lin, MD

This is a study of the feasibility of activating the auditory system by an electrode in direct contact with the cochlear nerve.

This is a feasibility study being conducted prior to development of a penetrating cochlear nerve stimulating electrode. Experiments will be conducted in patients who are undergoing surgery for resection of a vestibular schwannoma (VS). In the normal course of such a surgical procedure, the cochlear nerve is exposed and, in many cases, the cochlear nerve is resected or function of the cochlear nerve is otherwise disrupted. Typically, recording electrodes are placed on the scalp for the purpose of recording sound-evoked auditory brainstem responses (ABRs), which serve as a measure of the functional status of the cochlear nerve. In this intraoperative experimental procedure, a conventional bipolar nerve stimulating electrode will be placed in contact with the cochlear nerve and the nerve will be stimulated with electrical pulses. Activation of the auditory system by the electrical pulses will be evaluated by measurement of electrically-evoked ABRs, using the same scalp electrodes that are typically used for measurement of sound-evoked ABRs. The cochlear-nerve stimulating electrode will be in place only during the actual intraoperative test. No device will remain in the patient. The intraoperative experimental procedure is not intended to as a therapeutic measure for the patient's VS.

Test of feasibility of electrical stimulation of the cochlear nerve with a conventional bipolar nerve stimulator

Intraoperative Electrically-evoked ABRs in Patients Undergoing Vestibular Schwannoma Surgery

Electrical potentials recorded with scalp electrodes in response to electrical stimulation of the cochlear nerve

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Remote Ischemic Preconditioning in Vestibular Schwannoma Surgery	NCT05567341	Vestibular Schw...	Remote ischemic... Sham-control	18 Years -	University Hospital Tuebingen
Intraoperative Electrically-evoked ABRs in Patients Undergoing Vestibular Schwannoma Surgery	NCT05248113	Deafness	Electrical stim...	18 Years - 99 Years	University of California, Irvine

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