Neuro-Ox 2018: Assessment of Cerebral Oxygenation Under Three Clinically Relevant Conditions
Overview
- Phase
- N/A
- Intervention
- NIRS measurements on skin, skull and dura
- Conditions
- Neurosurgery
- Sponsor
- University Hospital Bispebjerg and Frederiksberg
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- ScO2 (NIRS-measured cerebral oxygen saturation)
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief 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. 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.
Investigators
Sofie Pedersen
MD, Primary Investigator
University Hospital Bispebjerg and Frederiksberg
Eligibility Criteria
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.
Arms & Interventions
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
Intervention: NIRS measurements on skin, skull and dura
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
Intervention: Phenylephrine's effect on brain oxygenation
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
Intervention: Normal vs. high inspired oxygen
Outcomes
Primary Outcomes
ScO2 (NIRS-measured cerebral oxygen saturation)
Time Frame: During surgical procedure
Difference in ScO2 between dura and skin (Primary analysis for substudy 1)
Secondary Outcomes
- PBrO2 (Partial pressure of brain tissue oxygen)('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)(Measurements will be performed as the surgeon exposes the skull.)
- ScO2 (NIRS-measured cerebral oxygenation)(NIRS signal is obtained continuously during the Phenylephrine intervention)