Exhaled Nitric Oxide : Biomarker of Acute Respiratory Distress Syndrome

NCT06250348 | Completed

• 1 other identifier: ENOBARDS
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

ARDS, Human; Nitric Oxyde

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Endogenous exhaled Nitric Oxyde (eNO)

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

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

Secondary Outcomes (1)

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

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

Study Arms (2)

ARDS patients

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

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

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.

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

Interventions

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.

ARDS patients; Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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

You may not qualify if:

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• patients who have withdrawn their consent.

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

CHU Grenoble Alpes

Grenoble, 38000, France

Location

Related Publications (1)

• 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.

  PMID: 33477122 BACKGROUND

MeSH Terms

Conditions

Respiratory Distress Syndrome; Pulmonary Edema

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Raphael BRIOT, MD ; PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2024
• First Posted: February 9, 2024
• Study Start: February 15, 2024
• Primary Completion: September 1, 2024
• Study Completion: January 5, 2025
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)