Brain-lung Interaction During Acute Respiratory Failure

Study acronym: BrainFlow
StatusRecruiting
PhaseNot specified
Started

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Trial flagged as At Risk
Primary completion moved at least 12 months later Jan 22, 2027 → Jan 22, 2028
See other at-risk trials from Assistance Publique - Hôpitaux de Paris

Record History

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  1. Notable Primary completion pushed from Jan 22, 2027 to Jan 22, 2028 Show 4 more changesShow less
    • Study completion pushed from Jan 22, 2027 to Jan 29, 2028
    • Interventions: EEG/NIRS/EMG (Diagnostic Test) to EEG/NIRS/EMG (Diagnostic Test)
    • Eligibility criteria expanded, about 17 words
    • Secondary endpoints: details revised at 2 of 7 entries
  2. Notable Recruitment opened
    • Primary and study completion pushed from Nov 2026 to Jan 22, 2027
    • Study sites: 1 to 2
    • Start date changed from estimate of Feb 2026 to Apr 22, 2026
    v3
  3. Minor Re-verified, no change to tracked fieldsv2
  4. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
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.
Trial Details
NCT Number NCT07279831
Lead Sponsor Assistance Publique - Hôpitaux de Paris
Conditions
(from sponsor)
Acute Respiratory Failure
Enrollment 25 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov