Neuro-Ox 2018: Assessment of Cerebral Oxygenation Under Three Clinically Relevant Conditions
NCT ID: NCT03682198
Last Updated: 2020-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
18 participants
INTERVENTIONAL
2018-09-24
2020-10-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
One strategy for all enrolled patients:
All patients will participate in three substudies, in which they also act as controls, with exposure to the same three interventions: 1) NIRS-measurement on skin, skull and dura, 2) Phenylephrine 0.1 mg iv., and 3) inspired oxygen fraction of 0.3 vs. 0.8
NIRS measurements on skin, skull and dura
During a neurosurgical procedure, we will measure the brain oxygenation with a NIRS-electrode, first on forehead skin, then on the skull and finally directly on dura.
Phenylephrine's effect on brain oxygenation
With a Clark-electrode (Licox(R)) in the white matter and a NIRS-electrode on the forehead skin, we will give a small dose (0.1 mg iv.) Phenylephrine.
Normal vs. high inspired oxygen
By the end of the neurosurgical procedure, still with a Clark-electrode in the white matter and a NIRS-electrode on forehead skin, we will change the inspired oxygen fraction from 0.3 to 0.8.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
NIRS measurements on skin, skull and dura
During a neurosurgical procedure, we will measure the brain oxygenation with a NIRS-electrode, first on forehead skin, then on the skull and finally directly on dura.
Phenylephrine's effect on brain oxygenation
With a Clark-electrode (Licox(R)) in the white matter and a NIRS-electrode on the forehead skin, we will give a small dose (0.1 mg iv.) Phenylephrine.
Normal vs. high inspired oxygen
By the end of the neurosurgical procedure, still with a Clark-electrode in the white matter and a NIRS-electrode on forehead skin, we will change the inspired oxygen fraction from 0.3 to 0.8.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Elective craniotomy
Exclusion Criteria
* Preoperative hypotension (defined as systolic blood pressure below 110 mmHg)
* Preoperative hypoxia (defined as peripheral oxygen saturation (SpO2) \< 90% without oxygen supplementation before surgery)
* No negative pregnancy test for women \<50 years.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Hospital Bispebjerg and Frederiksberg
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Sofie Pedersen
MD, Primary Investigator
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Rigshospitalet
Copenhagen, , Denmark
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Neuro-Ox 2018
Identifier Type: -
Identifier Source: org_study_id