How short high-oxygen exposures affect brain blood flow during mechanical ventilation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Mechanically ventilated adult ICU patients will undergo stepwise increases in the fraction of inspired oxygen (FiO2) while continuous transcranial Doppler (TCD) monitoring of the middle cerebral artery records cerebral blood flow velocity. Patients with baseline FiO2 < 0.5 will receive two hyperoxic steps (FiO2 0.5 then 1.0) and those with baseline FiO2 ≥ 0.5 will receive a single step (FiO2 1.0), each with a ~5-minute stabilization and a 10-minute recording period. Arterial blood gases will be sampled at baseline, at the end of each hyperoxic step, and after return to baseline, while ventilation, sedation, and vasoactive drug rates are kept constant. The protocol uses non-invasive monitoring and no additional invasive procedures beyond standard ICU care.

Why it matters

Who can join: the full rules

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

Where it's running

• Erasme Hospital - ULB
  Brussels, Belgium Recruiting

Study contacts

• Principal investigator: Fabio Silvio Taccone, MD, PhD — Hôpital Erasme - Université Libre de Bruxelles (ULB)
• Study coordinator: Michele Salvagno, MD
• Email: michele.salvagno@ulb.be
• Phone: +32471386614

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.