Ignite Creation Date:
2024-05-06 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06250348
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-09
First Post:
2024-01-29
Brief Title:
Exhaled Nitric Oxide Biomarker of Acute Respiratory Distress Syndrome
Sponsor:
University Hospital Grenoble
Organization:
University Hospital Grenoble
Study Overview
Official Title:
Exhaled Nitric Oxide Biomarker of Acute Respiratory Distress Syndrome
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ENOBARDS
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 ie 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 PaO2FiO2 ventilator-free days length of stay in intensive care and all-cause hospital mortality at 30 days
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 PaO2FiO2 ventilator-free days length of stay in intensive care and all-cause hospital mortality at 30 days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None