search
Back to results

Remote Ischemic Preconditioning in Vestibular Schwannoma Surgery (RIC-VS)

Primary Purpose

Vestibular Schwannoma

Status
Not yet recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Remote ischemic preconditioning
Sham-control
Sponsored by
University Hospital Tuebingen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Vestibular Schwannoma focused on measuring remote ischemic preconditioning, cochlear nerve, facial nerve, hearing, vestibular schwannoma surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Tuebingen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

RIC

Control

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

postoperative facial nerve function
facial nerve function according to House and Brackmann
postoperative facial nerve function
facial nerve function according to House and Brackmann

Full Information

First Posted
September 26, 2022
Last Updated
September 30, 2022
Sponsor
University Hospital Tuebingen
search

1. Study Identification

Unique Protocol Identification Number
NCT05567341
Brief Title
Remote Ischemic Preconditioning in Vestibular Schwannoma Surgery
Acronym
RIC-VS
Official Title
Remote Ischemic Preconditioning in Vestibular Schwannoma Surgery and Its Neuroprotective Effect on the Cochlear and Facial Nerve Function
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2022 (Anticipated)
Primary Completion Date
January 1, 2025 (Anticipated)
Study Completion Date
January 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Tuebingen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vestibular Schwannoma
Keywords
remote ischemic preconditioning, cochlear nerve, facial nerve, hearing, vestibular schwannoma surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
only the study nurse who performs the intervention is aware of the study arm
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RIC
Arm Type
Experimental
Arm Description
On the right upper extremity a blood pressure cuff is inflated to 200mmHg for 4x5min at the beginning of the surgery
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
On the right upper extremity a blood pressure cuff is inflated to 0mmHg for 4x5min at the beginning of the surgery
Intervention Type
Procedure
Intervention Name(s)
Remote ischemic preconditioning
Intervention 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
Intervention Type
Procedure
Intervention Name(s)
Sham-control
Intervention 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
Primary Outcome Measure Information:
Title
postoperative hearing
Description
hearing on pure tone audiometry according to AAO-HNS/Gardner-Robertson
Time Frame
3 months (± 6 weeks) after surgery
Secondary Outcome Measure Information:
Title
postoperative facial nerve function
Description
facial nerve function according to House and Brackmann
Time Frame
up to 8 days after surgery
Title
postoperative facial nerve function
Description
facial nerve function according to House and Brackmann
Time Frame
3 months (± 6 weeks) after surgery
Other Pre-specified Outcome Measures:
Title
postoperative hearing
Description
hearing on pure tone audiometry according to AAO-HNS/Gardner-Robertson
Time Frame
up to 8 days after surgery
Title
laboratory findings
Description
White blood count
Time Frame
within 4 hours after surgery
Title
laboratory findings
Description
C-reactive protein
Time Frame
within 4 hours after surgery
Title
laboratory findings
Description
Procalcitonin
Time Frame
within 4 hours after surgery
Title
laboratory findings
Description
Interleukin 6
Time Frame
within 4 hours after surgery
Title
laboratory findings
Description
D-Dimer
Time Frame
within 4 hours after surgery
Title
laboratory findings
Description
platelet count
Time Frame
within 4 hours after surgery
Title
laboratory findings
Description
International normalized ratio (INR)
Time Frame
within 4 hours after surgery
Title
laboratory findings
Description
activated partial thromboplastin time (aPTT)
Time Frame
within 4 hours after surgery
Title
laboratory findings
Description
White blood count
Time Frame
postoperatively, 1 day after surgery
Title
laboratory findings
Description
C-reactive protein
Time Frame
postoperatively, 1 day after surgery
Title
laboratory findings
Description
Procalcitonin
Time Frame
postoperatively, 1 day after surgery
Title
laboratory findings
Description
Interleukin 6
Time Frame
postoperatively, 1 day after surgery
Title
laboratory findings
Description
D-Dimer
Time Frame
postoperatively, 1 day after surgery
Title
laboratory findings
Description
platelet count
Time Frame
postoperatively, 1 day after surgery
Title
laboratory findings
Description
International normalized ratio (INR)
Time Frame
postoperatively, 1 day after surgery
Title
laboratory findings
Description
activated partial thromboplastin time (aPTT)
Time Frame
postoperatively, 1 day after surgery
Title
postoperative AEP
Description
Auditory evoked potentials after surgery
Time Frame
up to 8 days after surgery
Title
postoperative vertigo
Description
Vertigo according to dizziness handicap inventory (=DHI, score 0-100, higher scores are associated with a higher burden of dizziness)
Time Frame
up to 8 days after surgery
Title
postoperative vertigo
Description
Vertigo according to dizziness handicap inventory (=DHI, score 0-100, higher scores are associated with a higher burden of dizziness)
Time Frame
3 months (± 6 weeks) after surgery
Title
extent of schwannoma resection
Description
extent of schwannoma resection on the postoperative MRI
Time Frame
3 months (± 6 weeks) after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Helene V Hurth, MD
Phone
+49 7071 29 80325
Email
helene.hurth@med.uni-tuebingen.de
First Name & Middle Initial & Last Name or Official Title & Degree
Constantin Roder, Prof., MD
Email
constantin.roder@med.uni-tuebingen.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Contantin Roder, Prof., MD
Organizational Affiliation
Department of Neurosurgery Tuebingen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Helene V Hurth, MD
Organizational Affiliation
Department of Neurosurgery Tuebingen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Tuebingen
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Helene V Hurth, MD
Phone
+49 7071 29 80325
Email
helene.hurth@med.uni-tuebingen.de
First Name & Middle Initial & Last Name & Degree
Constantin Roder, Prof., MD
Email
constantin.roder@med.uni-tuebingen.de
First Name & Middle Initial & Last Name & Degree
Constantin Roder, Prof., MD
First Name & Middle Initial & Last Name & Degree
Helene V Hurth, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
IPD may be shared on request after completion of the study and as soon as data will be published.

Learn more about this trial

Remote Ischemic Preconditioning in Vestibular Schwannoma Surgery

We'll reach out to this number within 24 hrs