HYPER MIND - Hyperoxia Effects on Cerebral Hemodynamics

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorErasme University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients aged ≥18 years

Admitted to the intensive care unit (ICU)

Intubated and mechanically ventilated for ≤72 hours

Receiving volume-controlled mechanical ventilation

Disqualifiers

Age <18 years

Pregnancy

Extracorporeal membrane oxygenation (ECMO)

Continuous renal replacement therapy (CRRT)

Trial design

Design model

Single group

Treatments tested in this trial

  • Normobaric Hyperoxic Stimulus (NBHO)

    Other intervention

    The intervention consists of a short, controlled increase in the inspired oxygen fraction (FiO₂) delivered by the mechanical ventilator. Depending on baseline FiO₂, patients will receive: Depending on baseline FiO₂, patients will receive: Two-step NBHO (baseline FiO₂ \< 0.5): FiO₂ raised to 0.5 and then to 1.0 One-step NBHO (baseline FiO₂ ≥ 0.5): FiO₂ raised to 1.0 Each step includes 5 minutes to reach steady state followed by a 10-minute recording period. Cerebral blood flow velocity and autoregulation are continuously assessed using transcranial Doppler ultrasound.

Treatment groups

80 Participants
are divided into 1 treatment group
Group A: Experimental: Hyperoxic StimulusExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in Mean Flow Index (Mx) During Normobaric Hyperoxia

Dynamic cerebral autoregulation will be assessed using the mean flow index (Mx), calculated as the moving Pearson correlation coefficient between mean arterial pressure (MAP) and mean middle cerebral artery (MCA) blood flow velocity measured by transcranial Doppler ultrasonography. The outcome will be reported as the absolute change in Mx from baseline, calculated as the average Mx value during normobaric hyperoxia minus the baseline average.

Time frame
Baseline (prior to hyperoxic exposure), during normobaric hyperoxia steps, assessed during the intervention period, and after returning to baseline (assessed up to 20 minutes)

Secondary outcomes

1

Change in Middle Cerebral Artery Cerebral Blood Flow During Normobaric Hyperoxia

Cerebral hemodynamics will be assessed by transcranial Doppler ultrasonography of the middle cerebral artery (MCA). The cerebral blood flow velocity (cm/s) will be evaluated and analyzed as a change from baseline during normobaric hyperoxia. It will be expressed as the absolute change from baseline, calculated as the average value during the last 5 minutes of normobaric hyperoxia minus the baseline average.

Time frame
Baseline (prior to hyperoxic exposure), during normobaric hyperoxia, assessed during the intervention period (up to 30 minutes per study session), and after returning to baseline (assessed up to 20 minutes)
2

Change in Autoregulation Index (ARI) During Normobaric Hyperoxia

Cerebral autoregulation will also be evaluated using the Autoregulation Index (ARI) derived from transfer function-based step response analysis, expressed on a scale from 0 to 9. The outcome will be expressed as the absolute change from baseline during normobaric hyperoxia.

Time frame
Baseline (prior to hyperoxic exposure), during normobaric hyperoxia, assessed during the intervention period (up to 30 minutes per study session), and after returning to baseline (assessed up to 20 minutes)
3

Change in Transfer Function Analysis Parameters During Normobaric Hyperoxia

Transfer function analysis (TFA) between mean arterial pressure and middle cerebral artery blood flow velocity will be performed. Gain (cm/s/mmHg) will be analyzed in the low-frequency band (0.07-0.20 Hz). It will be expressed as absolute change from baseline during normobaric hyperoxia.

Time frame
Baseline (prior to hyperoxic exposure), during normobaric hyperoxia, assessed during the intervention period (up to 30 minutes per study session), and after returning to baseline (assessed up to 20 minutes)
4

Change in Transfer Function Analysis Parameters During Normobaric Hyperoxia

Description: Transfer function analysis (TFA) between mean arterial pressure and middle cerebral artery blood flow velocity will be performed. Phase (radians) will be analyzed in the low-frequency band (0.07-0.20 Hz). It will be expressed as absolute change from baseline during normobaric hyperoxia.

Time frame
Baseline (prior to hyperoxic exposure), during normobaric hyperoxia, assessed during the intervention period (up to 30 minutes per study session), and after returning to baseline (assessed up to 20 minutes)

Other outcomes

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