- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03666507
Vegetative Monitoring During Brainstem-associated Surgery
November 3, 2022 updated by: University Hospital Tuebingen
Intraoperative Monitoring of Heart rate variability, Blood pressure variability, Baroreceptorsensivity etc.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
103
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Tübingen, Germany, 72076
- Department of Neurosurgery
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Brain tumor patients
Description
Inclusion Criteria:
- age 0-99
- brain tumor
Exclusion Criteria:
- no consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Brain stem associated tumors
|
Intraoperative Monitoring during resection of brain tumor
|
Tumors without brain stem assocation
|
Intraoperative Monitoring during resection of brain tumor
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Heart rate variability (HRV)
Time Frame: intraoperatively
|
Comparison of HRV in the 2 groups (brain stem-associated vs. non associated surgery)
|
intraoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of cardiovascular complications
Time Frame: intraoperatively
|
Comparison of no. of cardiovascular complications (cardiac arrest, sudden tachy/bradyarryhthmia, hyper/hypotension, trigeminocardiac reflex) in the 2 groups
|
intraoperatively
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Martin U Schuhmann, Prof, University Hospital Tuebingen
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 28, 2018
Primary Completion (Actual)
August 28, 2020
Study Completion (Actual)
March 28, 2021
Study Registration Dates
First Submitted
August 30, 2018
First Submitted That Met QC Criteria
September 7, 2018
First Posted (Actual)
September 11, 2018
Study Record Updates
Last Update Posted (Actual)
November 4, 2022
Last Update Submitted That Met QC Criteria
November 3, 2022
Last Verified
April 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Otorhinolaryngologic Neoplasms
- Otorhinolaryngologic Diseases
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Ear Diseases
- Central Nervous System Neoplasms
- Nervous System Neoplasms
- Cranial Nerve Diseases
- Neuroendocrine Tumors
- Nerve Sheath Neoplasms
- Peripheral Nervous System Neoplasms
- Cranial Nerve Neoplasms
- Infratentorial Neoplasms
- Neuroma
- Vestibulocochlear Nerve Diseases
- Retrocochlear Diseases
- Brain Neoplasms
- Neurilemmoma
- Neuroma, Acoustic
- Brain Stem Neoplasms
Other Study ID Numbers
- ANSTue
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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