Brain-lung Interaction During Acute Respiratory Failure

NCT07279831 | Recruiting

• 1 other identifier: APHP251258
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 2

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.

Conditions

Acute Respiratory Failure

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  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

  before and 1 hour after initiation of high flow nasal cannulae

Secondary Outcomes (7)

• 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

• pre-inspiratory potential

  before and 1 hour after initiation of high flow nasal cannulae

• Riemann classifier

  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

Study Arms (1)

Adult patients admitted to critical care for acute renal failure

Diagnostic Test: EEG/NIRS/EMG

Interventions

EEG/NIRS/EMG DIAGNOSTIC_TEST

Two 10-minute recordings will be made. Each recording will include continuous collection of EEG, NIRS, and EMG data from the scalene muscles, as well as collection of intensive care monitoring variables every minute.

Adult patients admitted to critical care for acute renal failure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients admitted to critical care for acute renal failure

You may qualify if:

• \- 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)

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (2)

Médecine Intensive - Réanimation, Hôpital Pitié Salpêtrière

Paris, 75013, France

RECRUITING

Service de Médecine Intensive et Réanimation, Hôpital Pitié Salpêtrière

Paris, France

NOT YET RECRUITING

Study Officials

• Alexandre Demoule

  APHP

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandre Demoule

CONTACT

0142167888; alexandre.demoule@aphp.fr

Martin Dres

CONTACT

0142167965; martin.dres@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: December 12, 2025
• Study Start: April 22, 2026
• Primary Completion (Estimated): January 22, 2027
• Study Completion (Estimated): January 22, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
• Access Criteria: Researchers who provide a methodologically sound proposal.

Locations

FR (2)