Actively Recruiting
HYPERMIND - Hyperoxia Effects on Cerebral Hemodynamics in Mechanically Ventilated ICU Patients
Led by Erasme University Hospital · Updated on 2026-01-29
80
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to better understand how short periods of high oxygen levels affect blood flow in the brain of patients who are intubated and mechanically ventilated in the Intensive Care Unit (ICU). Many ICU patients receive more oxygen than necessary, and high blood oxygen levels are common. The study focuses on how these short high oxygen exposures impact cerebral circulation and autoregulation, which are not well understood. Patients will receive one or two brief increases in the oxygen level delivered by the ventilator depending on their baseline oxygen needs. Those with lower baseline oxygen needs will have two steps: increasing to 0.5 and then to 1.0 fraction of inspired oxygen (FiO2). Those with higher baseline needs will have one step to 1.0 FiO2. Each step includes 5 minutes to stabilize followed by 10 minutes of monitoring with transcranial Doppler ultrasound to assess cerebral blood flow and autoregulation. After the exposure, oxygen levels return to baseline. Participants will be monitored continuously during the procedure, including brain blood flow via ultrasound and arterial blood pressure. Blood gas samples will be collected before, during, and after oxygen adjustments to track oxygen and carbon dioxide levels. Sedation, ventilation, and medication rates will remain stable. Safety is closely observed, and the procedure stops immediately if instability occurs. The main outcome is change in mean flow index (Mx) during and after hyperoxia, with additional measures of cerebral blood flow and autoregulatory function.
CONDITIONS
Brief Title
HYPER MIND - Hyperoxia Effects on Cerebral Hemodynamics
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients aged 18 years or older
- Admitted to the intensive care unit (ICU)
- Intubated and mechanically ventilated for at least 72 hours
- Receiving volume-controlled mechanical ventilation
- Arterial partial pressure of carbon dioxide (PaCO2) between 35 and 45 mmHg
- Invasive arterial blood pressure monitoring in place
- Adequate transcranial Doppler (TCD) acoustic window
- Clinically suitable for a brief normobaric hyperoxic stimulus
- Expected to receive one or two hyperoxic steps based on baseline oxygen requirements
You will not qualify if you...
- Age under 18 years
- Pregnancy
- Receiving extracorporeal membrane oxygenation (ECMO)
- Receiving continuous renal replacement therapy (CRRT)
- Contraindications to hyperoxia as judged by the treating physician
- Severe hemodynamic instability requiring vasopressor dose changes during the study
- Inability to obtain a reliable transcranial Doppler signal
- Any clinical condition posing unacceptable risk during hyperoxic exposure
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 30 minutes per study session
Participants undergo one or two brief normobaric hyperoxic stimuli while mechanically ventilated. The inspired oxygen fraction (FiO₂) is transiently increased to 0.5 and/or 1.0 depending on baseline oxygen requirements, with continuous monitoring of cerebral blood flow and autoregulation using transcranial Doppler ultrasound.
1 session during mechanical ventilation
Trial Site Locations
Total: 1 location
1
Erasme Hospital - ULB
Brussels, Belgium
Actively Recruiting
Research Team
M
Michele Salvagno, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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