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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03682198
Other study ID # Neuro-Ox 2018
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 24, 2018
Est. completion date October 1, 2020

Study information

Verified date November 2020
Source University Hospital Bispebjerg and Frederiksberg
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
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.
Drug:
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.

Locations

Country Name City State
Denmark Rigshospitalet Copenhagen

Sponsors (1)

Lead Sponsor Collaborator
University Hospital Bispebjerg and Frederiksberg

Country where clinical trial is conducted

Denmark, 

Outcome

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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