Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07377162

HYPER MIND - Hyperoxia Effects on Cerebral Hemodynamics

Led by Erasme University Hospital · Updated on 2026-01-29

80

Participants Needed

1

Research Sites

260 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study aims to better understand how short periods of exposure to 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 strictly necessary, and high blood oxygen levels (hyperoxemia) are very common. However, the immediate effects of short hyperoxic exposures on cerebral circulation and autoregulation remain poorly understood. In this study, patients who already require mechanical ventilation for medical reasons will undergo a brief and controlled increase in the oxygen delivered through the ventilator (FiO₂). During this time, we will continuously monitor blood flow in one of the main brain arteries using a non-invasive ultrasound technique called transcranial Doppler (TCD). The goal is to evaluate how cerebral blood flow, pulsatility, and autoregulatory capacity change during and after a short hyperoxic stimulus. No additional invasive procedures are required beyond standard ICU monitoring, except for the temporary adjustment of the ventilator's oxygen settings and arterial blood gas sampling, which are part of usual care in critically ill patients. Participation does not provide direct clinical benefit but may help improve future oxygen management in ICU patients. The study involves minimal risk, as short hyperoxic exposures are already common in routine care and will be interrupted immediately in case of any adverse event.

CONDITIONS

Official 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
  • Admitted to the intensive care unit (ICU)
  • Intubated and mechanically ventilated for 72 hours
  • Receiving volume-controlled mechanical ventilation
  • Arterial partial pressure of carbon dioxide (PaCO) between 35 and 45 mmHg
  • Invasive arterial blood pressure monitoring in place
  • Adequate transcranial Doppler (TCD) acoustic window
  • Clinically judged suitable for a brief normobaric hyperoxic stimulus
  • Expected to receive one or two hyperoxic steps based on baseline FiO requirements: a) Baseline FiO < 0.5: two-step hyperoxic stimulus (FiO 0.5 followed by FiO 1.0); b) Baseline FiO  0.5: one-step hyperoxic stimulus (FiO 1.0)
Not Eligible

You will not qualify if you...

  • Age <18 years
  • Pregnancy
  • Receiving extracorporeal membrane oxygenation (ECMO)
  • Receiving continuous renal replacement therapy (CRRT)
  • Contraindications to hyperoxia as judged by the physician
  • Severe hemodynamic instability requiring vasopressor dose changes during monitoring
  • Inability to obtain reliable transcranial Doppler signal through temporal windows
  • Any condition posing unacceptable risk during hyperoxic exposure as judged by the physician

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Erasme Hospital - ULB

Brussels, Belgium

Actively Recruiting

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Research Team

M

Michele Salvagno, MD

CONTACT

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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HYPER MIND - Hyperoxia Effects on Cerebral Hemodynamics | DecenTrialz