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

NCT03682198 | Completed

• 1 other identifier: Neuro-Ox 2018
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurosurgery; Elective Craniotomy; General Anaesthesia

Outcome Measures

Primary Outcomes (1)

• ScO2 (NIRS-measured cerebral oxygen saturation)

  Difference in ScO2 between dura and skin (Primary analysis for substudy 1)

  During surgical procedure

Secondary Outcomes (4)

• PBrO2 (Partial pressure of brain tissue oxygen)

  During surgical procedure

• 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

Study Arms (1)

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

Device: NIRS measurements on skin, skull and dura; Drug: Phenylephrine's effect on brain oxygenation; Drug: Normal vs. high inspired oxygen

Interventions

NIRS measurements on skin, skull and dura DEVICE

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.

One strategy for all enrolled patients:

Phenylephrine's effect on brain oxygenation DRUG

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.

One strategy for all enrolled patients:

Normal vs. high inspired oxygen DRUG

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.

One strategy for all enrolled patients:

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (\>18 years) patients
• Elective craniotomy

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital Bispebjerg and Frederiksberg: lead

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Primary Investigator

Study Record Dates

• First Submitted: August 28, 2018
• First Posted: September 24, 2018
• Study Start: September 24, 2018
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: November 3, 2020

Record last verified: 2020-11

Locations

DK (1)