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Completed

NCT Number: NCT06250348

Exhaled Nitric Oxide : Biomarker of Acute Respiratory Distress Syndrome

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Grenoble Alpes

Grenoble, 38000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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  • patients who have withdrawn their consent.

Treatment and study plan

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

Other

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.

Primary outcomes

  1. Endogenous exhaled Nitric Oxyde (eNO)

    Time frame: Measurement of eNO over a period of 10 minutes just after induction of anesthesia

    The primary endpoint is a significantly higher eNO concentration in ARDS patients.

Secondary outcomes

  1. Secondary endpoints will assess correlations between eNO concentrations and usual ARDS severity criteria

    Time frame: Measurement of eNO over a period of 10 minutes within the first 24 hours after intubation

    ARDS 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Acronym: ENOBARDS

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Feb 9, 2024
Registry last updated
Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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