ROS in TBI Patients in Relation to Level of Oxygenation.

NCT ID: NCT05101278

Last Updated: 2022-04-28

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-11-30
• Study Completion Date: 2024-12-31

Brief Summary

This project an observational study performed on patients with severe Traumatic Brain Injury (TBI) treated at Neurosurgical ICU (NICU) at Karolinska University Hospital. The purpose of this study is to evaluate the effects of various oxygenation levels on production rate of Reactive Oxygen Species (ROS) in patients with severe traumatic brain injury (TBI). The patients will be included in the study after the placement of intracranial monitoring device consisting of intracranial pressure gage (Codman), microdialysis (MD), and Licox oxygen electrode for measurement of partial pressure of oxygen in brain tissue (pBtO2). Intracranial monitoring is inserted on clinical indications and is used for early detection of deleterious processes in brain tissue such as hypoxia or hypoperfusion and for purpose of guiding of given therapies such as cerebral perfusion pressure (CPP), oxygenation, dosage of vasoactive drugs etc. Despite the technical possibilities to monitor all these physiological parameters, there are no clear guidelines how to interpret the MD and pBtO2 data and implement it in clinical decision making. One of the controversies deals with optimization of oxygen levels: some authors point out the importance of adequate brain tissue oxygenation, whereas other researchers are worried about the possible negative effects of excessive oxygen levels such as increased production of ROS or facilitating pulmonary atelectasis, contributing to adverse outcome.

The purpose of this study is to investigate the effect of various oxygenation levels on ROS production in TBI patients.

This pilot study is designed to measure short-lived ROS in blood and microdialysis fluid samples of TBI patients during alternating periods of normal vs temporarily increased oxygenation levels under normobaric conditions (normal atmospheric pressure).

Conditions

Systemic Oxygenation vs ROS Formation in TBI Patients

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

1. Severe isolated TBI (GCS<8, AIS =<3), CT-verified TBI (tSDH,tEDH, tSAH, contusion bleedings) caused by blunt or penetrating trauma.

2. Established intracranial monitoring (ICP, MD, LiCox pBtO2) at NICU.

3. Age >= 18

4. Time from trauma from 0 to 4 days.

5. Informed consent from Close relative.

6. Systemic hyperoxygenation can be used in patients with pBtO2 <20 mmHg, based on clinical decision.

Exclusion Criteria

1. Major extracranial injury, AIS >3

2. Brain dead or expected survival <24 hours

3. Pregnancy

4. Respiratory insufficiency FiO2> 40%

6. No consent from relative.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Region Stockholm

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Karolinska University Hospital

Stockholm, , Sweden

Countries

Sweden

Facility Contacts

Michael Nekludov, MD PhD

Role: primary

michael.nekludov@regionstockholm.se

Other Identifiers

K2020-1148

Identifier Type: -

Identifier Source: org_study_id