Clinical trial NCT06250348: Exhaled Nitric Oxide : Biomarker of Acute Respiratory Distress Syndrome
Official title: Exhaled Nitric Oxide : Biomarker of Acute Respiratory Distress Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ARDS, Human
Nitric Oxyde
Keywords: ARDS
Lung oedema
Capillary-alveolar permeability
Nitric Oxyde
Laser Spectroscopy
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2024-02-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ARDS patients (from any cause) in ICU Control group : healthy patients (ASA I or II) operated for a minor surgery (thyroid or parathyroid)

Brief summary: The aim of the study is to see if endogenous exhaled Nitric Oxyde (eNO) concentrations measured are significantly higher in ARDS patients admitted in ICU ; compared to control subjects in good health with no lung disease or global inflammation, operated under general anesthesia (i.e. intubated and ventilated) for thyroid or parathyroid.

Detailed description: The measurement of endogenous exhaled NO is monitored using a laser spectrometer machine connected to the expiratory circuit of the respirator. The measure is non-invasive and made by sampling expiratory gaz like for capnography.

In control subjects, the measurement period corresponds to the first ten minutes after induction of anesthesia (with intubation) before surgical incision.

In ARDS patients in intensive care, the measurement of eNO is made in the first twenty-four hours after intubation and ventilation of the patient with mechanical respirator.

The primary endpoint is a significantly higher eNO concentration in patients suffering from Acute Respiratory Distress Syndrome (ARDS).

Secondary endpoints will assess correlations between eNO concentrations and usual ARDS severity criteria: PaO2/FiO2; ventilator-free days; length of stay in intensive care and all-cause hospital mortality at 30 days.

Eligibility criteria: Inclusion Criteria:

* For ARDS patients :

  * Patients with ARDS (according to the Berlin criteria) admitted in intensive care unit and intubated for less than 24 hours.
* For control patients :

  * Patients with no major disease (classified 1 or 2 in the classification of the American Society of Anaesthesiology)
  * Patients undergoing general anaesthesia for a thyroïd or parathyroïd surgery

Exclusion Criteria:

* Minors under the age of 18 years old
* Pregnant women
* prisoners
* patients who have withdrawn their consent.

Primary outcomes:
measure: Endogenous exhaled Nitric Oxyde (eNO)
timeFrame: Measurement of eNO over a period of 10 minutes just after induction of anesthesia
Secondary outcomes:
measure: Secondary endpoints will assess correlations between eNO concentrations and usual ARDS severity criteria
timeFrame: Measurement of eNO over a period of 10 minutes within the first 24 hours after intubation
Other outcomes:
Locations:
city: Grenoble
country: France
facility: CHU Grenoble Alpes
Study officials:
affiliation: Laboratoire TIMC - Team PRETA UMR CNRS-UGA 5525 ; Grenoble Alpes University
name: Raphael BRIOT, MD ; PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chollier T, Richard L, Romanini D, Brouta A, Martin JL, Moro C, Briot R, Ventrillard I. Monitoring of endogenous nitric oxide exhaled by pig lungs during ex-vivo lung perfusion. J Breath Res. 2021 Feb 11;15(2). doi: 10.1088/1752-7163/abde95.