Exhaled Nitric Oxide : Biomarker of Acute Respiratory Distress Syndrome (ENOBARDS)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: ARDS, Human; Nitric Oxyde
• Intervention / Treatment: Other: Non invasive measure of endogenous exhaled Nitric Oxyde in exhaled gaz, by a laser spectrometer

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.

• Study Type: Observational
• Enrollment (Estimated): 24

Contacts and Locations

• Study Contact: Name: Raphael BRIOT, MD ; PhD; Phone Number: 33 476634286; Email: rbriot@chu-grenoble.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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)

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary endpoints will assess correlations between eNO concentrations and usual ARDS severity criteria	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.	Measurement of eNO over a period of 10 minutes within the first 24 hours after intubation

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Investigators: Principal Investigator: Raphael BRIOT, MD ; PhD, Laboratoire TIMC - Team PRETA UMR CNRS-UGA 5525 ; Grenoble Alpes University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2024
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: January 29, 2024
• First Submitted That Met QC Criteria: February 8, 2024
• First Posted (Estimated): February 9, 2024

Study Record Updates

• Last Update Posted (Estimated): February 9, 2024
• Last Update Submitted That Met QC Criteria: February 8, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: ARDS; Laser Spectroscopy; Lung oedema; Capillary-alveolar permeability; Nitric Oxyde
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Protective Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Antioxidants; Free Radical Scavengers; Endothelium-Dependent Relaxing Factors; Gasotransmitters; Nitric Oxide
• Other Study ID Numbers: ENOBARDS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: In this single-center observational study, anonymized data are collected and centralized by the principal investigator before being analyzed by the team of statisticians.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No