ARDS, HumanENOBARDSNCT06250348
Exhaled Nitric Oxide : Biomarker of Acute Respiratory Distress Syndrome
An observational study of ARDS, Human and Nitric Oxyde, run by University Hospital, Grenoble at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ARDS, Human, Nitric Oxyde
- What is being tested?
- Non invasive measure of endogenous exhaled Nitric Oxyde in exhaled gaz, by a laser spectrometer
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 15 Feb 2024to 5 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- 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
Who cannot join
- Minors under the age of 18 years old
- Pregnant women
- prisoners
- patients who have withdrawn their consent.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- ARDS, Human, Nitric Oxyde
- Being tested
- Non invasive measure of endogenous exhaled Nitric Oxyde in exhaled gaz, by a laser spectrometer
- Keywords
- ARDS, Lung oedema, Capillary-alveolar permeability, Nitric Oxyde, Laser Spectroscopy
- Medical subject headings
- Respiratory Distress Syndrome, Pulmonary Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non invasive measure of endogenous exhaled Nitric Oxyde in exhaled gaz, by a laser spectrometerOther
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.
| Study group | Role | What they receive |
|---|---|---|
| ARDS patients | ARDS patients admitted in ICU ;intubated and mechanically ventilated for less than 24 hours Receives: 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. Receives: Other: Non invasive measure of endogenous exhaled Nitric Oxyde in exhaled gaz, by a laser spectrometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endogenous exhaled Nitric Oxyde (eNO)
The primary endpoint is a significantly higher eNO concentration in ARDS patients.
Measured: 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
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.
Measured: Measurement of eNO over a period of 10 minutes within the first 24 hours after intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start15 Feb 2024
- Primary completion1 Sep 2024
- Study completion5 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ARDS, HumanStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raphael BRIOT, MD ; PhD, Principal investigator, Laboratoire TIMC - Team PRETA UMR CNRS-UGA 5525 ; Grenoble Alpes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06250348
- Sponsor's protocol ID
- ENOBARDS
- Acronym
- ENOBARDS
- Status last verified
- Mar 2025
- First submitted
- 29 Jan 2024
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: In this single-center observational study, anonymized data are collected and centralized by the principal investigator before being analyzed by the team of statisticians.
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.
PubMed 33477122
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exhaled Nitric Oxide : Biomarker of Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT06250348
- Acronym / sponsor ID
- ENOBARDS / ENOBARDS
- Conditions
- ARDS, Human, Nitric Oxyde
- Keywords
- ARDS, Lung oedema, Capillary-alveolar permeability, Nitric Oxyde, Laser Spectroscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 5 Jan 2025 (actual)
- First posted
- 9 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARDS patients | – | Other: Non invasive measure of endogenous exhaled Nitric Oxyde in exhaled gaz, by a laser spectrometerARDS patients admitted in ICU ;intubated and mechanically ventilated for less than 24 hours |
| Control group | – | Other: Non invasive measure of endogenous exhaled Nitric Oxyde in exhaled gaz, by a laser spectrometerHealthy subjects without pulmonary nor inflammatory pathology, who underwent a benign surgical procedure (thyroid or parathyroid surgery) requiring general anesthesia with intubation and mechanical ventilation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (5 listed)
- For ARDS patients :
- For control patients :
Key exclusion criteria (4 listed)
- Minors under the age of 18 years old
- Pregnant women
- prisoners
- patients who have withdrawn their consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non invasive measure of endogenous exhaled Nitric Oxyde in exhaled gaz, by a laser spectrometerA 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. | Other | ARDS patients, Control group |
Primary outcome
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.
1 secondary outcome
Secondary endpoints will assess correlations between eNO concentrations and usual ARDS severity criteria
Time frame: Measurement of eNO over a period of 10 minutes within the first 24 hours after intubation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Background: PubMed 33477122Chollier 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.
- Individual participant dataSharing planned: No. In this single-center observational study, anonymized data are collected and centralized by the principal investigator before being analyzed by the team of statisticians.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raphael BRIOT, MD ; PhD principal investigator
Laboratoire TIMC - Team PRETA UMR CNRS-UGA 5525 ; Grenoble Alpes University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ARDS, Human and Nitric Oxyde, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endogenous exhaled Nitric Oxyde (eNO) (time frame: Measurement of eNO over a period of 10 minutes just after induction of anesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06250348, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.