Neuro-Ox 2018: Assessment of Cerebral Oxygenation Under Three Clinically Relevant Conditions

Neurosurgery Clinical Trial

Official title:

Neuro-Ox 2018: Assessment of Cerebral Oxygenation Under Three Clinically Relevant Conditions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03682198
• Other study ID #: Neuro-Ox 2018
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Elective Craniotomy
• General Anaesthesia
• Neurosurgery

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