Exhaled Nitric Oxide : Biomarker of Acute Respiratory Distress Syndrome

NCT ID: NCT06250348

Last Updated: 2025-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-15

Study Completion Date

2025-01-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

ARDS, Human Nitric Oxyde

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ARDS patients

ARDS patients admitted in ICU ;intubated and mechanically ventilated for less than 24 hours

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

Intervention Type 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.

Control group

Healthy subjects without pulmonary nor inflammatory pathology, who underwent a benign surgical procedure (thyroid or parathyroid surgery) requiring general anesthesia with intubation and mechanical ventilation.

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

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Non 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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Grenoble

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Raphael BRIOT, MD ; PhD

Role: PRINCIPAL_INVESTIGATOR

Laboratoire TIMC - Team PRETA UMR CNRS-UGA 5525 ; Grenoble Alpes University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CHU Grenoble Alpes

Grenoble, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 33477122 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ENOBARDS

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.