Oxygen overload? study probes brain impact in ventilated patients

NCT ID NCT07377162

Knowledge-focused Sponsor: Erasme University Hospital Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at how short periods of high oxygen affect blood flow in the brains of ICU patients on breathing machines. Researchers will briefly increase the oxygen given through the ventilator and use ultrasound to monitor brain artery blood flow. The goal is to understand these effects better, which could lead to safer oxygen use in the future. Participation involves no direct benefit but minimal risk.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Normobaric Hyperoxic Stimulus (NBHO) - a short, controlled increase in oxygen delivered through a ventilator
What this could lead to: If successful, this study could help doctors better manage oxygen levels in ICU patients, potentially reducing brain injury risks.
What could go wrong: This is a small, early-stage observational study with no direct treatment benefit. Results may not apply to all ICU patients, and the intervention carries minimal risk of oxygen toxicity.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2024

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria * 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 (PaCO₂) between 35 and 45 mmHg * Invasive arterial blood pressure monitoring in place * Adequate transcranial Doppler (TCD) acoustic window * Clinically judged to be suitable for a brief normobaric hyperoxic stimulus * Expected to receive one or two hyperoxic steps based on baseline FiO₂ requirements: a) Baseline FiO₂ \< 0.5: two-step hyperoxic stimulus (FiO₂ 0.5 followed by FiO₂ 1.0); b) Baseline FiO₂ ≥ 0.5: one-step hyperoxic stimulus (FiO₂ 1.0) Exclusion Criteria: * Age \<18 years * Pregnancy * Extracorporeal membrane oxygenation (ECMO) * Continuous renal replacement therapy (CRRT) * Contraindications to hyperoxia, as judged by the treating physician * Severe hemodynamic instability requiring changes in vasopressor dose during the recording period * Inability to obtain a reliable transcranial Doppler signal through the temporal acoustic windows * Any clinical condition deemed by the treating physician to pose unacceptable risk during hyperoxic exposure

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Conditions

The condition(s) this trial relates to.

choroideremia Critical Illness Hyperoxia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cerebral autoregulation Cerebrovascular circulation Critical illness Hyperoxemia Mechanical ventilation

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

1 site. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Oxygen overload? study probes brain impact in ventilated patients

What the study statuses mean