NCT03666507

Brief Summary

Intraoperative Monitoring of Heart rate variability, Blood pressure variability, Baroreceptorsensivity etc.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 28, 2018

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

August 30, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 11, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 28, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2021

Completed
Last Updated

November 4, 2022

Status Verified

April 1, 2021

Enrollment Period

2 years

First QC Date

August 30, 2018

Last Update Submit

November 3, 2022

Conditions

Brain Tumor, RecurrentVestibular SchwannomaBrainstem NeoplasmBrainstem Glioma

Outcome Measures

Primary Outcomes (1)

  • Heart rate variability (HRV)

    Comparison of HRV in the 2 groups (brain stem-associated vs. non associated surgery)

    intraoperatively

Secondary Outcomes (1)

  • Rate of cardiovascular complications

    intraoperatively

Study Arms (2)

Brain stem associated tumors

Brain stem associated tumors

Procedure: Intraoperative Monitoring during resection of brain tumor

Tumors without brain stem assocation

Tumors without brain stem assocation

Procedure: Intraoperative Monitoring during resection of brain tumor

Interventions

Intraoperative Monitoring during resection of brain tumorPROCEDURE

Intraoperative Monitoring during resection of brain tumor

Brain stem associated tumorsTumors without brain stem assocation

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Brain tumor patients

You may qualify if:

  • age 0-99
  • brain tumor

You may not qualify if:

  • no consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurosurgery

Tübingen, 72076, Germany

Location

MeSH Terms

Conditions

Brain NeoplasmsNeuroma, AcousticBrain Stem Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurilemmomaNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeuromaNerve Sheath NeoplasmsNeoplasms, Nerve TissueCranial Nerve NeoplasmsPeripheral Nervous System NeoplasmsVestibulocochlear Nerve DiseasesRetrocochlear DiseasesEar DiseasesOtorhinolaryngologic DiseasesOtorhinolaryngologic NeoplasmsCranial Nerve DiseasesInfratentorial Neoplasms

Study Officials

  • Martin U Schuhmann, Prof

    University Hospital Tuebingen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2018

First Posted

September 11, 2018

Study Start

August 28, 2018

Primary Completion

August 28, 2020

Study Completion

March 28, 2021

Last Updated

November 4, 2022

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)