Strain and Blood Inflammatory Markers as Prognostic Tools for ARDS AMIS (ARDS - Markers of Inflammation - Strain)

Centre Hospitalier Universitaire de Nice

Status: Terminated

Conditions: Acute Respiratory Distress Syndrome

Treatments: Other: Inflammatory markers

Study type: Interventional

Funder types: Other

Identifiers

NCT02003326

13AOI07

Details and patient eligibility

About

The objective is determine the strain measured at the bedside could be a dynamic prognostic marker of during Acute respiratory Distress Syndrome (ARDS).

Full description

Nowadays ARDS severity, and therapeutic efficiency are evaluated using PaO2/FiO2 ratio. Inflammation is a cornerstone of ARDS and the ratio is not a sufficiently accurate tool to predict the evolution of ARDS. A reproducible marker would be helpful to adapt the therapeutics and maybe limit their deleterious effects.

The investigators made the hypothesis that patients moderate to severe ARDS (comparable PaO2/FiO2 ratio) with a higher strain may have higher inflammation.

Moderate/severe ARDS will be ventilate with protective ventilation (low tidal volume and PEEP set to limit plateau pressure under 30cmH2O). Markers of inflammation will be measured in the broncho Alveolar Lavage the first day and in the blood the following days. Strain will be measured at the bedside using the nitrogen washout-washin. Markers of inflammation and strain will be analysed with ventilatory and oxygenation.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Moderate to severe ARDS (Berlin Definition)
• Acute beginning <1 week
• PaO2/FiO2 ratio ≤ 200 after 24h mechanical ventilation with PEEP≥5cmH2O
• Bilateral opacities on chest X-ray
• Respiratory failure not fully explain by cardiac failure or fluid overload
• Informed consent signed by the next of kin and secondarily by the patient when awake
• Patient with social insurance

No Inclusion criteria

• Age < 18
• Pregnancy a pregnancy test will be done to women of childbearing age
• Chronic obstructive pulmonary disease
• Severe hypoxemia PaO2/FiO2 <50% with high PEEP
• Immunosuppressive treatment
• Immunodeficiency onco-hematology, HIV

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Inflammatory markers

Other group

Description:

All patients with inclusion criteria (ARDS moderate and severe: Berlin definition) and absence of non inclusion criteria will have a broncho alveolar wash at day 0 and blood sample every three day to measure inflammatory markers. All patients will receive protective ventilation with low tidal volume and pressures limited (Pplat \<30cmH2O). End-Expiratory Lung Volume and strain will be measured every 6 hours from the inclusion to the extubation.

Treatment:

Other: Inflammatory markers