Optimal Brain Oxygenation in Neurologic Intensive Care Unit : The NeurO2 Study

NCT04935866 | Unknown

• 1 other identifier: MP-20-2021-5673
• Study Type: observational
• Target: 286
• Locations: 1 country
• Sites: 2

Brief Summary

The NeurO2 study is a multicenter observational study looking at NIRS monitoring in neurocrocritically ill patients during the acute phase of care following an acute brain injury. The study is nested within the HEMOTION Trial and the SAHaRA Trial

Conditions

Traumatic Brain Injury; Subarachnoid Hemorrhage; Brain Injuries; Near-Infrared Spectroscopy; Intensive Care Neurological Disorder; Anemia

Outcome Measures

Primary Outcomes (1)

• Glasgow Outcome Scale extended

  The GOSe is an ordinal scale on 8 points evaluating the neurological functional outcome in neurocritically ill patients where 1 represents death and 8 the best possible outcome.

  6 months

Secondary Outcomes (4)

• Mortality

  6 months

• Hospital length of stay

  through study completion, an average of 6 months

• ICU length of stay

  through study completion, an average of 6 months

• EQ-5D-5L

  6 months

Interventions

Near-infrared spectroscopy (NIRS) OTHER

Non invasive brain oxygenation monitoring with Near-Infrared Spectroscopy (NIRS) technology. Patients enrolled in the NeurO2 study will have bilateral NIRS sensors applied to the forehead according to manufacturer recommendations. Data will be monitored continuously throughout the study intervention in the parent trials (HEMOTION and SAHaRA trials) in the neurocritical care unit. Data will be extracted from the device at the end of the study period.

Eligibility Criteria

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

Study Population

Adult patients hospitalized with a traumatic brain injury or with aneurysmal subarachnoid hemorrhage already enrolled in the HEMOTION Trial or the SAHaRA Trial

You may qualify if:

• Enrolment in one of the parent trials (HEMOTION or SAHaRA trials)
• HEMOTION trial (acute moderate of severe blunt traumatic brain injury (Glasgow Coma Score18 \[GCS\] ≤ 12))
• SAHaRA trial (acute subarachnoid hemorrhage as confirmed by treating neurosurgeon or neuro-interventionist and supported by blood in subarachnoid space resulting from a ruptured aneurysm)
• Adult patients (age ≥18 years old)
• Patients suffering from anemia (Hb ≤100 g/L)

You may not qualify if:

• Contraindications or known objections to blood transfusions
• Active bleeding with hemodynamic instability at the time of enrollment
• Decision to withdraw or withhold life-sustaining therapies made
• NIRS monitoring not reliable

Sponsors & Collaborators

• CHU de Quebec-Universite Laval: lead
• Ottawa Hospital Research Institute: collaborator
• Canadian Critical Care Trials Group: collaborator
• Canadian Traumatic Brain Injury Research Consortium: collaborator

Study Sites (2)

The Ottawa Hospital

Ottawa, Ontario, Canada

RECRUITING

CHU de Québec - Université Laval (Hôpital de l'Enfant-Jésus)

Québec, Quebec, G1J-1Z4, Canada

RECRUITING

Related Links

• Canadian Traumatic Brain Injury Research Consortium

MeSH Terms

Conditions

Brain Injuries, Traumatic; Subarachnoid Hemorrhage; Brain Injuries; Anemia

Interventions

Spectroscopy, Near-Infrared

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Intracranial Hemorrhages; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Alexis F Turgeon, MD MSc FRCPC

  CHU de Québec-Universite Laval Research Center, Universite Laval

  PRINCIPAL INVESTIGATOR

• Shane W English, MD MSc FRCPC

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lucy Clayton, MSc

CONTACT

418-525-4444; lucy.clayton.hsj@ssss.gouv.qc.ca

Angie Tuttle, MSc

CONTACT

613-737-8899; antuttle@ohri.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 15, 2021
• First Posted: June 23, 2021
• Study Start: May 7, 2021
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2025
• Last Updated: August 18, 2022

Record last verified: 2022-08

Locations

CA (2)