Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07377162

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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

Loading map...

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

Similar Trials

PROTECT-ICU: Impact of an Educational Intervention on the Im...

Post Intensive Care Syndrome (PICS)

Actively Recruiting

2 locations

Establishment of a Multi-Center Big Data System for Severe I...

Critical Illness

Actively Recruiting

1 location

A Multi-Modal Combination Intervention to Promote Cognitive ...

Critical Illness

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here