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Tests treatment safety and results for Acute Respiratory Distress Syndrome
Official title Early Verticalization of the Patient With Acute Respiratory Distress Syndrome: Assessment of Feasibility and Safety.
ClinicalTrials.gov ID: NCT04472260
What this study is testing
- What it's testing
- Acute Respiratory Distress Syndrome (ARDS) is defined according to the Berlin definition (1) as diffuse lung damage occurring in patients with a predisposing risk factor. Positioning in the prone position (PP) has been shown to decrease mortality in patients with moderate to severe ARDS.
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
- Major patient \> 18 years of age
- ARDS patients with PaO2/FiO2 ratio \< 150 at any time within 24 hours prior to the screening visit
- Hemodynamically stable patient with mean arterial pressure (MAP) \> 65 mmHg maintained without vasopressor or with norepinephrine at a dosage of less...
- Patient having already undergone at least 1 but less than 5 PP sessions
- Patient under continuous intravenous sedation (IVSE) or not responding to simple order.
You likely can't join if
- Pregnant women (positive pregnancy test during screening)
- Breastfeeding women
- Protected Majors
- Body weight greater than 198 kg (bed load limit)
- Patient with one or two lower limbs amputated at the trans tibial or upper level
- Contraindication to standing (orthopedic fracture, neurological instability with the presence of an intracranial pressure sensor or an external...
See the full eligibility criteria
- Major patient \> 18 years of age
- ARDS patients with PaO2/FiO2 ratio \< 150 at any time within 24 hours prior to the screening visit
- Hemodynamically stable patient with mean arterial pressure (MAP) \> 65 mmHg maintained without vasopressor or with norepinephrine at a dosage of less than 0.5 µg/kg/min.
- Patient having already undergone at least 1 but less than 5 PP sessions
- Patient under continuous intravenous sedation (IVSE) or not responding to simple order.
- Written consent of support person or family.
- Pregnant women (positive pregnancy test during screening)
- Breastfeeding women
- Protected Majors
- Body weight greater than 198 kg (bed load limit)
- Patient with one or two lower limbs amputated at the trans tibial or upper level
- Contraindication to standing (orthopedic fracture, neurological instability with the presence of an intracranial pressure sensor or an external ventricular shunt....)
- Deep venous thrombosis of the lower limbs with curative anticoagulation for less than 48 hours
- Hemodynamic instability (MAP \< 65 mm Hg) despite the use of norepinephrine at a dosage equal or greater than 0.5 µg/kg/min.
- Person under guardianship or trusteeship
- Non-beneficiary patient of a health insurance plan
- Moribund patient
The study team makes the final eligibility decision.
Where it's taking place
- Orléans, 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 Orléans, 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.