Assessment of brain oxygenation in three clinical situations

Neuro-Ox-2018: Assessment of cerebral oxygenation under three clinically relevant conditions

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-002776-83-DK

Enrollment

Registered

2017-07-07

Start date

2018-04-17

Completion date

Unknown

Last updated

2021-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients undergoing neurosurgery MedDRA version: 20.0 Level: LLT Classification code 10053764 Term: Brain tumor operation System Organ Class: 100000004865

Interventions

Trade Name: Medical oxygen Pharmaceutical Form: INN or Proposed INN: OXYGEN Concentration unit: % percent Concentration type: range Concentration number: -30-80 Trade Name: Metaoxedrin Pharmaceutica

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adult patients (=18 years) scheduled for elective skull base craniotomy. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: Patients undergoing re-operation, patients with pre-operative hypotension (defined as sBP < 100 mmHg), patients with pre-operative hypoxia (SpO2 < 90% without oxygen supplementation before surgery); no negative pregnancy test for women <50 years.

Design outcomes

Primary

Measure	Time frame
Main Objective: Assessment of cerebral oxygenation under three clinically relevant conditions;Secondary Objective: Assessment of cerebral oxygenation under three clinically relevant conditions;Primary end point(s): Changes in cerebral oxygenation;Timepoint(s) of evaluation of this end point: During anaesthesia	—

Secondary

Measure	Time frame
Secondary end point(s): Cerebral oxygenation with non-licox measurements;Timepoint(s) of evaluation of this end point: During anaesthesia	—

Countries

Denmark

Contacts

Public ContactSofie Pedersen

Bispebjerg Hospital

sofie.schroeder.pedersen.01@regionh.dk

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026