Brain–lung interaction during sudden severe low-oxygen respiratory failure

Brain-lung Interactions in Patients Receiving High-flow Humidified Oxygen for de Novo Acute Hypoxemic Respiratory Failure

We will try EEG, NIRS, and neck muscle recordings before and one hour after starting high-flow nasal oxygen in adults with sudden low-oxygen respiratory failure to see how the brain and lungs interact.

Quick facts

• Study type: Observational
• Enrollment: 25 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Assistance Publique - Hôpitaux de Paris (Academic / other)
• Locations: 2 sites (Paris and 1 other locations)
• Trial ID: NCT07279831 on ClinicalTrials.gov

What this trial studies

This is an observational study enrolling non-intubated adults admitted to the ICU with de novo acute hypoxemic respiratory failure for whom clinicians start high-flow nasal cannula (HFNC). EEG, near-infrared spectroscopy (NIRS), and scalenus muscle EMG recordings will be collected immediately before and one hour after HFNC initiation. Researchers will extract EEG spectral densities across standard frequency bands from multiple cortical regions and combine these signals with NIRS and EMG data to characterize brain–ventilation interactions. The goal is to link brain signal changes to respiratory support response and provide physiological markers that could inform future management.

Who should consider this trial

Good fit: Adults (≥18) recently admitted to the ICU with de novo acute hypoxemic respiratory failure who are starting HFNC and are not intubated or imminently needing intubation.

Not a fit: Patients with exacerbations of chronic respiratory disease, indications for noninvasive ventilation, marked hypercapnia, low consciousness (GCS <13), or central neurologic disease are excluded and are unlikely to benefit from these findings.

Why it matters

Potential benefit: If successful, the measurements could help identify brain signatures that predict response to HFNC and potentially reduce unnecessary intubations.

How similar studies have performed: EEG and NIRS approaches have been used previously in intubated patients, but applying these combined measurements to non-intubated HFNC patients is a novel extension.

Eligibility criteria

Inclusion Criteria:

* \- Age ≥ 18 years
* Admitted to the intensive care within the last 48 hours
* De novo acute hypoxemic respiratory failure with an indication for high-flow nasal cannula (HFNC), defined by the combination of the following three criteria:

  * Tachypnea \> 25 breaths/min or labored breathing
  * PaO2 (partial pressure of oxygen ) /FiO2 ( fraction of inspired oxygen ) ≤ 200 mmHg
  * Unilateral or bilateral alveolar opacities on chest X-ray
* Decision by the attending physician to initiate HFNC treatment
* After information, the patient or next of kind did not refuse to participate (according to the French law, written informed consent is waived)

Exclusion Criteria:

* \- Exacerbation of an underlying chronic respiratory disease
* Acute cardiogenic pulmonary edema indicating non-invasive ventilation (NIV)
* Hypercapnia \> 45 mmHg indicating NIV
* Glasgow Coma Scale \< 13
* Imminent intubation
* Underlying central neurological disease likely to alter EEG signals
* Pregnancy or breastfeeding
* Lack of health insurance coverage
* Patient under legal protection

Where this trial is running

Paris and 1 other locations

• Médecine Intensive - Réanimation, Hôpital Pitié Salpêtrière — Paris, France (Recruiting)
• Service de Médecine Intensive et Réanimation, Hôpital Pitié Salpêtrière — Paris, France (Not_yet_recruiting)

Study contacts

• Principal investigator: Alexandre Demoule — Aphp
• Study coordinator: Alexandre Demoule

Conditions Acute Respiratory Failure; Acute respiratory failure; High flow nasal cannulae; Electroencephalogram; Near infrared spectroscopy