NeurosurgeryNCT03682198
Neuro-Ox 2018: Assessment of Cerebral Oxygenation Under Three Clinically Relevant Conditions
A study testing NIRS measurements on skin, skull and dura, Phenylephrine's effect on brain oxygenation and Normal vs. high inspired oxygen in people with Neurosurgery and Elective Craniotomy, run by University Hospital Bispebjerg and Frederiksberg at 1 site in Denmark.
Trial summary
This is a prospective observational study, consisting of 3 substudies carried out during elective neurosurgery under general anaesthesia. Each participant will take part in all 3 substudies. First, the capability of Near Infra Red Spectroscopy (NIRS) to measure the brain oxygenation is examined. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurosurgery, Elective Craniotomy, General Anaesthesia
- What is being tested?
- NIRS measurements on skin, skull and dura, Phenylephrine's effect on brain oxygenation and Normal vs. high inspired oxygen
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteDenmark
- Study dates
- 24 Sep 2018to 1 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (>18 years) patients
- Elective craniotomy
Who cannot join
- Repeat craniotomy
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
This is a prospective observational study, consisting of 3 substudies carried out during elective neurosurgery under general anaesthesia. Each participant will take part in all 3 substudies. First, the capability of Near Infra Red Spectroscopy (NIRS) to measure the brain oxygenation is examined. A NIRS-electrode is placed on forehead skin, on the skull, and on dura. Secondly, a small dose of Phenylephrine is given, and the brain oxygenation is measured by a Clark-electrode and a NIRS-electrode, to see how Phenylephrine affects these measurements. In the third substudy, the brain oxygenations' (NIRS and Licox) response to an inspired oxygen fraction of 0.30 vs. 0.80 is investigated.
- Conditions
- Neurosurgery, Elective Craniotomy, General Anaesthesia
- Being tested
- NIRS measurements on skin, skull and dura, Phenylephrine's effect on brain oxygenation, Normal vs. high inspired oxygen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIRS measurements on skin, skull and duraDevice
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 oxygenationDrug
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 oxygenDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| One strategy for all enrolled patients: | Other | 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 Receives: Device: NIRS measurements on skin, skull and dura; Drug: Phenylephrine's effect on brain oxygenation; Drug: Normal vs. high inspired oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
ScO2 (NIRS-measured cerebral oxygen saturation)
Difference in ScO2 between dura and skin (Primary analysis for substudy 1)
Measured: During surgical procedure
Secondary outcomes (4)
PBrO2 (Partial pressure of brain tissue oxygen)
Cerebral oxygenation, measured by a Clark-electrode (Licox (R)) (Primary outcome measure for substudy 2)
Measured: During surgical procedure
PBrO2 (Partial pressure of brain tissue oxygen)
Cerebral oxygenation during inspired oxygen fraction 0.80 vs. 0.30 (Primary outcome for substudy 3)
Measured: 'Normoxia' is induced with FiO2 = 0.30 for 5 minutes, and then changed to 'Hyperoxia' with FiO2 = 0.80 for the subsequent 5 minutes, while registering the Licox-signal.
ScO2 (NIRS-measured cerebral oxygen saturation)
Difference in ScO2 between dura and skull, and between skull and skin (this will be the secondary analyses of substudy 1)
Measured: Measurements will be performed as the surgeon exposes the skull.
ScO2 (NIRS-measured cerebral oxygenation)
NIRS-signal during Phenylephrine intervention (this will be the secondary outcome of substudy 2)
Measured: NIRS signal is obtained continuously during the Phenylephrine intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2018
- Study start24 Sep 2018
- Primary completion1 Oct 2020
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeurosurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Bispebjerg and Frederiksberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sofie Pedersen, University Hospital Bispebjerg and Frederiksberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03682198
- Sponsor's protocol ID
- Neuro-Ox 2018
- Status last verified
- Nov 2020
- First submitted
- 28 Aug 2018
- Last updated
- 3 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuro-Ox 2018: Assessment of Cerebral Oxygenation Under Three Clinically Relevant Conditions
- ClinicalTrials.gov ID
- NCT03682198
- Acronym / sponsor ID
- Neuro-Ox 2018
- Conditions
- Neurosurgery, Elective Craniotomy, General Anaesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University Hospital Bispebjerg and FrederiksbergUniversity, hospital or other
- Study start
- 24 Sep 2018 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 24 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective observational study, consisting of 3 substudies carried out during elective neurosurgery under general anaesthesia. Each participant will take part in all 3 substudies. First, the capability of Near Infra Red Spectroscopy (NIRS) to measure the brain oxygenation is examined. A NIRS-electrode is placed on forehead skin, on the skull, and on dura. Secondly, a small dose of Phenylephrine is given, and the brain oxygenation is measured by a Clark-electrode and a NIRS-electrode, to see how Phenylephrine affects these measurements. In the third substudy, the brain oxygenations' (NIRS and Licox) response to an inspired oxygen fraction of 0.30 vs. 0.80 is investigated.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| One strategy for all enrolled patients: | Other | Device: NIRS measurements on skin, skull and dura, Drug: Phenylephrine's effect on brain oxygenation, Drug: Normal vs. high inspired oxygenAll 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult (>18 years) patients
- Elective craniotomy
Key exclusion criteria (4 listed)
- Repeat craniotomy
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NIRS measurements on skin, skull and duraDuring 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. | Device | One strategy for all enrolled patients: |
| Phenylephrine's effect on brain oxygenationWith 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. | Drug | One strategy for all enrolled patients: |
| Normal vs. high inspired oxygenBy 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. | Drug | One strategy for all enrolled patients: |
Primary outcome
ScO2 (NIRS-measured cerebral oxygen saturation)
Time frame: During surgical procedure
Difference in ScO2 between dura and skin (Primary analysis for substudy 1)
4 secondary outcomes
PBrO2 (Partial pressure of brain tissue oxygen)
Time frame: During surgical procedure
PBrO2 (Partial pressure of brain tissue oxygen)
Time frame: 'Normoxia' is induced with FiO2 = 0.30 for 5 minutes, and then changed to 'Hyperoxia' with FiO2 = 0.80 for the subsequent 5 minutes, while registering the Licox-signal.
ScO2 (NIRS-measured cerebral oxygen saturation)
Time frame: Measurements will be performed as the surgeon exposes the skull.
ScO2 (NIRS-measured cerebral oxygenation)
Time frame: NIRS signal is obtained continuously during the Phenylephrine intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NIRS measurements on skin, skull and dura, Phenylephrine's effect on brain oxygenation and Normal vs. high inspired oxygen in people with Neurosurgery and Elective Craniotomy, run by University Hospital Bispebjerg and Frederiksberg at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ScO2 (NIRS-measured cerebral oxygen saturation) (time frame: During surgical procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2020.