Exhaled Nitric Oxide : Biomarker of Acute Respiratory Distress Syndrome

ARDS, Human Clinical Trial

— ENOBARDS  

Official title:

Exhaled Nitric Oxide : Biomarker of Acute Respiratory Distress Syndrome

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06250348
• Other study ID #: ENOBARDS
• Status: Not yet recruiting
• Start date: February 2024
• Est. completion date: January 2025

Study information

• Verified date: February 2024
• Source: University Hospital, Grenoble
• Contact: Raphael BRIOT, MD ; PhD
• Phone: 33 476634286
• Email: rbriot[@]chu-grenoble.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: January 2025
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Lung Injury
• ARDS, Human
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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