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New treatment option for Acute Respiratory Distress Syndrome
Official title Personalized Tidal Volume in ARDS (VT4HEMOD)
ClinicalTrials.gov ID: NCT05406570
What this study is testing
- What it's testing
- Treatment of acute respiratory distress syndrome (ARDS) relies on invasive mechanical ventilation with supposedly protective settings (low tidal volume ventilation). Mortality of ARDS remains high in observational studies (40 to 50%).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age greater then 18 years old
- ARDS according to the BERLIN definition with PaO2/FiO2 ratio ≤ 150 mm Hg
- invasive mechanical ventilation in volume controlled mode with tidal volume set to 6 ml/kg predicted body weight
- use of sedation and neuromuscular-blocking agents
- arterial catheter allowing computation of pulse contour cardiac output calibrated with thermodilution
You likely can't join if
- Previous inclusion in current study
- Acute cor pulmonale
- ECMO
- Arterial pH \< 7.21 despite respiratory rate set to a maximum of 35/min
- Pneumothorax or bronchopleural fistula
- Decision to withdraw or withhold life sustaining treatment with 24 hours from inclusion
See the full eligibility criteria
- Age greater then 18 years old
- ARDS according to the BERLIN definition with PaO2/FiO2 ratio ≤ 150 mm Hg
- invasive mechanical ventilation in volume controlled mode with tidal volume set to 6 ml/kg predicted body weight
- use of sedation and neuromuscular-blocking agents
- arterial catheter allowing computation of pulse contour cardiac output calibrated with thermodilution
- central venous catheter implanted in the superior vena cava territory
- esophageal balloon
- Computed tomography planned by attending physician
- Previous inclusion in current study
- Acute cor pulmonale
- ECMO
- Arterial pH \< 7.21 despite respiratory rate set to a maximum of 35/min
- Pneumothorax or bronchopleural fistula
- Decision to withdraw or withhold life sustaining treatment with 24 hours from inclusion
- Contra-indication of transport to imaging facility
- Intracranial hypertension
- Tricuspid or pulmonary mechanical valve
- Tricuspid or pulmonary infective endocarditis
- Pace maker with intracardiac leads
- Right ventricle tumor
- Complete left bundle block
- Intrathoracic metallic device
- COPD
- Cardiac arrythmia
- Vesical pressure \> 15 mm Hg
- Lower limb amputation
- Inferior vena cava thrombosis
- Patient under an exclusion period relative to participation to another clinical trial
- Patient under a legal protective measure
- Patient not affiliated to social security
- lac of patient/representative consent
- Pregnancy
- Breast feeding
The study team makes the final eligibility decision.
Where it's taking place
- Lyon, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lyon, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.