Trial Title:
Remote Ischemic Preconditioning in Vestibular Schwannoma Surgery
NCT ID:
NCT05567341
Condition:
Vestibular Schwannoma
Conditions: Official terms:
Neurilemmoma
Neuroma, Acoustic
Conditions: Keywords:
remote ischemic preconditioning
cochlear nerve
facial nerve
hearing
vestibular schwannoma surgery
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
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)
Primary purpose:
Prevention
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description:
only the study nurse who performs the intervention is aware of the study arm
Intervention:
Intervention type:
Procedure
Intervention name:
Remote ischemic preconditioning
Description:
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
Arm group label:
RIC
Intervention type:
Procedure
Intervention name:
Sham-control
Description:
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
Arm group label:
Control
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.
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.
Criteria for eligibility:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University Hospital Tuebingen
Address:
City:
Tuebingen
Zip:
72076
Country:
Germany
Contact:
Last name:
Helene V Hurth, MD
Phone:
+49 7071 29 80325
Email:
helene.hurth@med.uni-tuebingen.de
Contact backup:
Last name:
Constantin Roder, Prof., MD
Email:
constantin.roder@med.uni-tuebingen.de
Investigator:
Last name:
Constantin Roder, Prof., MD
Email:
Principal Investigator
Investigator:
Last name:
Helene V Hurth, MD
Email:
Sub-Investigator
Start date:
October 1, 2022
Completion date:
January 1, 2025
Lead sponsor:
Agency:
University Hospital Tuebingen
Agency class:
Other
Source:
University Hospital Tuebingen
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05567341
