Remote Ischemic Preconditioning in Vestibular Schwannoma Surgery

Vestibular Schwannoma Clinical Trial

— RIC-VS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05567341
• Other study ID #: 489-0-0
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: January 1, 2025

Study information

• Verified date: September 2022
• Source: University Hospital Tuebingen
• Contact: Helene V Hurth, MD
• Phone: +49 7071 29 80325
• Email: helene.hurth[@]med.uni-tuebingen.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neurilemmoma
• Neuroma, Acoustic
• Vestibular Schwannoma

Intervention

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
• 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

Locations

Country	Name	City	State
Germany	University Hospital Tuebingen	Tuebingen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	postoperative hearing	hearing on pure tone audiometry according to AAO-HNS/Gardner-Robertson	up to 8 days after surgery
Other	laboratory findings	White blood count	within 4 hours after surgery
Other	laboratory findings	C-reactive protein	within 4 hours after surgery
Other	laboratory findings	Procalcitonin	within 4 hours after surgery
Other	laboratory findings	Interleukin 6	within 4 hours after surgery
Other	laboratory findings	D-Dimer	within 4 hours after surgery
Other	laboratory findings	platelet count	within 4 hours after surgery
Other	laboratory findings	International normalized ratio (INR)	within 4 hours after surgery
Other	laboratory findings	activated partial thromboplastin time (aPTT)	within 4 hours after surgery
Other	laboratory findings	White blood count	postoperatively, 1 day after surgery
Other	laboratory findings	C-reactive protein	postoperatively, 1 day after surgery
Other	laboratory findings	Procalcitonin	postoperatively, 1 day after surgery
Other	laboratory findings	Interleukin 6	postoperatively, 1 day after surgery
Other	laboratory findings	D-Dimer	postoperatively, 1 day after surgery
Other	laboratory findings	platelet count	postoperatively, 1 day after surgery
Other	laboratory findings	International normalized ratio (INR)	postoperatively, 1 day after surgery
Other	laboratory findings	activated partial thromboplastin time (aPTT)	postoperatively, 1 day after surgery
Other	postoperative AEP	Auditory evoked potentials after surgery	up to 8 days after surgery
Other	postoperative vertigo	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
Other	postoperative vertigo	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
Other	extent of schwannoma resection	extent of schwannoma resection on the postoperative MRI	3 months (± 6 weeks) after surgery
Primary	postoperative hearing	hearing on pure tone audiometry according to AAO-HNS/Gardner-Robertson	3 months (± 6 weeks) after surgery
Secondary	postoperative facial nerve function	facial nerve function according to House and Brackmann	up to 8 days after surgery
Secondary	postoperative facial nerve function	facial nerve function according to House and Brackmann	3 months (± 6 weeks) after surgery