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Exhaled Nitric Oxide : Biomarker of Acute Respiratory Distress Syndrome

Exhaled Nitric Oxide : Biomarker of Acute Respiratory Distress Syndrome

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06250348
Acronym
ENOBARDS
Enrollment
20
Registered
2024-02-09
Start date
2024-02-15
Completion date
2025-01-05
Last updated
2025-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ARDS, Human, Nitric Oxyde

Keywords

ARDS, Lung oedema, Capillary-alveolar permeability, Nitric Oxyde, Laser Spectroscopy

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.

Interventions

OTHERNon invasive measure of endogenous exhaled Nitric Oxyde in exhaled gaz, by a laser spectrometer

A sample of exhaled gases is taken from the expiratory part of the respirator circuit (same way as a capnometry measurement). A laser spectrometer continuously and non-invasively monitors online the concentrations of endogenous NO exhaled by patients.

Sponsors

University Hospital, Grenoble
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Endogenous exhaled Nitric Oxyde (eNO)Measurement of eNO over a period of 10 minutes just after induction of anesthesiaThe primary endpoint is a significantly higher eNO concentration in ARDS patients.

Secondary

MeasureTime frameDescription
Secondary endpoints will assess correlations between eNO concentrations and usual ARDS severity criteriaMeasurement of eNO over a period of 10 minutes within the first 24 hours after intubationARDS severity criteria are: Partial arterial pressure of oxygen divided by inspired fraction of oxygen (PaO2/FiO2); ventilator-free days; length of stay in intensive care and all-cause hospital mortality at 30 days.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026