Brain-lung Interaction During Acute Respiratory Failure

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

- Age ≥ 18 years

Admitted to the intensive care within the last 48 hours

Tachypnea > 25 breaths/min or labored breathing

PaO2 (partial pressure of oxygen ) /FiO2 ( fraction of inspired oxygen ) ≤ 200 mmHg

Disqualifiers

- 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

Trial population

Adult patients admitted to critical care for acute renal failure

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: Adult patients admitted to critical care for acute renal failure1 intervention

Trial outcomes

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

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

Secondary outcomes

1

The density of the gamma, beta, alpha, theta, and delta frequency spectrum

The density of the gamma frequency spectrum (30-100 Hz) of the EEG in the following cortical regions: medial region of the left prefrontal cortex, anterior region of the right and left cingulate gyrus, posterior region of the right and left cingulate gyrus, right and left insula, right and left somatosensory cortex, right and left angular gyrus, right and left lateral prefrontal cortex, and right and left supplementary motor area. and the densities of the beta (13-30 Hz), alpha (8-12 Hz), theta (4-8 Hz), and delta (0.5-4 Hz) frequency spectra in each of the aforementioned right and left cortical regions.

Time frame
before and 1 hour after initiation of high flow nasal cannulae
2

Connectivity

Connectivity between the medial region of the prefrontal cerebral cortex, the anterior region of the cingulate gyrus, the posterior region of the cingulate gyrus, the insula, the medial region of the prefrontal cortex, the somatosensory cortex, the angular gyrus, the lateral prefrontal cortex and the supplementary motor area, right and left, for the gamma (30-100 Hz), beta (13-30 Hz), right and left, alpha (8-12 Hz), right and left, theta (4-8 Hz) and delta (0.5-4 Hz), right and left frequency spectra.

Time frame
before and 1 hour after initiation of high flow nasal cannulae
3

pre-inspiratory potential

the presence of a pre-inspiratory potential will be searched for

Time frame
before and 1 hour after initiation of high flow nasal cannulae
4

Riemann classifier

The area under the curve of the receiver operating characteristics (ROC) of the Riemann classifier will be measured.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.