Exhaled Nitric Oxide : Biomarker of Acute Respiratory Distress Syndrome

Completed

• Conditions: ARDS, Human; Nitric Oxyde
• Interventions: Other: Non invasive measure of endogenous exhaled Nitric Oxyde in exhaled gaz, by a laser spectrometer

• Registration Number: NCT06250348
• Lead Sponsor: University Hospital, Grenoble

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.

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 Timeline

• Study First Submitted: 2024-01-29
• Study First Submitted QC: 2024-02-08
• Study First Posted: 2024-02-09
• Study Start: 2024-02-15
• Primary Completion: 2024-09-01
• Study Completion: 2025-01-05
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ARDS patients	Non invasive measure of endogenous exhaled Nitric Oxyde in exhaled gaz, by a laser spectrometer	ARDS patients admitted in ICU ;intubated and mechanically ventilated for less than 24 hours
Control group	Non invasive measure of endogenous exhaled Nitric Oxyde in exhaled gaz, by a laser spectrometer	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.

Primary Outcome Measures

Name	Time	Method
Endogenous exhaled Nitric Oxyde (eNO)	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 Outcome Measures

Name	Time	Method
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	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.

Trial Locations

Locations (1)

CHU Grenoble Alpes; 🇫🇷 Grenoble, France