Neurosurgery Clinical Trial
Official title:
Neuro-Ox 2018: Assessment of Cerebral Oxygenation Under Three Clinically Relevant Conditions
Verified date | November 2020 |
Source | University Hospital Bispebjerg and Frederiksberg |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 18 |
Est. completion date | October 1, 2020 |
Est. primary completion date | October 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Adult (>18 years) patients - Elective craniotomy Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Denmark | Rigshospitalet | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
University Hospital Bispebjerg and Frederiksberg |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | ScO2 (NIRS-measured cerebral oxygen saturation) | Difference in ScO2 between dura and skin (Primary analysis for substudy 1) | During surgical procedure | |
Secondary | PBrO2 (Partial pressure of brain tissue oxygen) | Cerebral oxygenation, measured by a Clark-electrode (Licox (R)) (Primary outcome measure for substudy 2) | During surgical procedure | |
Secondary | PBrO2 (Partial pressure of brain tissue oxygen) | Cerebral oxygenation during inspired oxygen fraction 0.80 vs. 0.30 (Primary outcome for substudy 3) | '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. | |
Secondary | 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) | Measurements will be performed as the surgeon exposes the skull. | |
Secondary | ScO2 (NIRS-measured cerebral oxygenation) | NIRS-signal during Phenylephrine intervention (this will be the secondary outcome of substudy 2) | NIRS signal is obtained continuously during the Phenylephrine intervention |
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---|---|---|---|
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