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Clinical Trials/NCT07279831
NCT07279831RecruitingNot Applicable

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

Assistance Publique - Hôpitaux de Paris3 sites in 1 country25 target enrollmentStarted: April 22, 2026Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
25
Locations
3
Primary Endpoint
density of the gamma frequency spectrum of the EEG in the medial region of the right prefrontal cerebral cortex

Study Overview

Brief Summary

Acute hypoxemic de novo respiratory failure (AHRF) is a common cause of admission to the intensive care unit (ICU). Its main cause is community-acquired pneumonia. Prevention of intubation relies, among other things, on high-flow nasal canulae (HFNC). However, approximately 40% of patients are intubated despite HFNC.

Our team has developed measurements derived from electroencephalograms (EEG) and near-infrared spectroscopy (NIRS) that enable the study of brain-ventilation interactions. To date, these tools have been studied exclusively in intubated patients. the investigators now wish to study them in non-intubated patients.

The objective of this study is to investigate the relationship between the brain and lungs in adult patients admitted to the intensive care unit for acute hypoxemic respiratory failure and for whom the attending physician has decided to initiate HFNC.

Before and one hour after the introduction of HFNC, electroencephalogram (EEG), near-infrared spectroscopy (NIRS), and electromyogram (EMG) of the Scalen muscles will be collected.

From these recordings, the following variables will be collected: 1) The density of the gamma (30-100 Hz), beta (13-30 Hz), alpha (8-12 Hz), theta (4-8 Hz), and delta (0.5-4 Hz) frequency spectrum of the EEG in each of the following right and left cortical regions: medial region of the prefrontal cortex, anterior region of the cingulate gyrus, posterior region of the cingulate gyrus, insula, somatosensory cortex, angular gyrus, lateral prefrontal cortex, and supplementary motor area; 2) Connectivity between these regions for each frequency spectrum; 3) Pre-inspiratory potential; 4) Rieman classifier; 5) Coherence and Granger causality between each frequency spectrum and the scalene muscles EMG.

These variables will be compared before and 1 hour after initiation of HFNC and between patients who will be intubated because of HFNC failure and those who will not.

Detailed Description

Acute hypoxemic de novo respiratory failure (AHRF) is a common cause of admission to the intensive care unit (ICU). Its main cause is community-acquired pneumonia. Prevention of intubation relies, among other things, on high-flow nasal canulae (HFNC). However, approximately 40% of patients are intubated despite HFNC.

Our team has developed measurements derived from electroencephalograms (EEG) and near-infrared spectroscopy (NIRS) that enable the study of brain-ventilation interactions. To date, these tools have been studied exclusively in intubated patients. the investigators now wish to study them in non-intubated patients.

The objective of this study is to investigate the relationship between the brain and lungs in adult patients admitted to the intensive care unit for acute hypoxemic respiratory failure and for whom the attending physician has decided to initiate HFNC.

Before and one hour after the introduction of HFNC, electroencephalogram (EEG), near-infrared spectroscopy (NIRS), and electromyogram (EMG) of the Scalen muscles will be collected.

From these recordings, the following variables will be collected: 1) The density of the gamma (30-100 Hz), beta (13-30 Hz), alpha (8-12 Hz), theta (4-8 Hz), and delta (0.5-4 Hz) frequency spectrum of the EEG in each of the following right and left cortical regions: medial region of the prefrontal cortex, anterior region of the cingulate gyrus, posterior region of the cingulate gyrus, insula, somatosensory cortex, angular gyrus, lateral prefrontal cortex, and supplementary motor area; 2) Connectivity between these regions for each frequency spectrum; 3) Pre-inspiratory potential; 4) Rieman classifier; 5) Coherence and Granger causality between each frequency spectrum and the scalene muscles EMG.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Adult patients admitted to critical care for acute renal failure

Intervention: EEG/NIRS/EMG (Diagnostic Test)

Outcomes

Primary Outcomes

density of the gamma frequency spectrum of the EEG in the medial region of the right prefrontal cerebral cortex

Time Frame: before and 1 hour after initiation of high flow nasal cannulae

density of the gamma frequency spectrum (30 - 100 Hz) of the EEG in the medial region of the right prefrontal cerebral cortex, before initiation of HFO ( = high-flow oxygen), then 1 hour after its initiation

Secondary Outcomes

  • pre-inspiratory potential(before and 1 hour after initiation of high flow nasal cannulae)
  • Change in amplitude for fNIRS frequencies (fNIRS)(before and 1 hour after initiation of high flow nasal cannulae)
  • Coherence and Granger Causality(before and 1 hour after initiation of high flow nasal cannulae)
  • The density of the gamma, beta, alpha, theta, and delta frequency spectrum(before and 1 hour after initiation of high flow nasal cannulae)
  • Connectivity(before and 1 hour after initiation of high flow nasal cannulae)
  • Riemann classifier(before and 1 hour after initiation of high flow nasal cannulae)
  • Oxyhemoglobin (HbO2) concentration(before and 1 hour after initiation of high flow nasal cannulae)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (3)

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