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Clinical Trials/NCT06250348
NCT06250348
Completed
Not Applicable

Exhaled Nitric Oxide : Biomarker of Acute Respiratory Distress Syndrome

University Hospital, Grenoble1 site in 1 country20 target enrollmentFebruary 15, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
ARDS, Human
Sponsor
University Hospital, Grenoble
Enrollment
20
Locations
1
Primary Endpoint
Endogenous exhaled Nitric Oxyde (eNO)
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 15, 2024
End Date
January 5, 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital, Grenoble
Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Endogenous exhaled Nitric Oxyde (eNO)

Time Frame: 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 Outcomes

  • 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 Sites (1)

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