Current Concepts of ARDS: A Narrative Review.
Michele Umbrello, Paolo Formenti, Luca Bolgiaghi...
https://pubmed.ncbi.nlm.nih.gov/28036088Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID04472260
Early Verticalization of the Patient With Acute Respiratory Distress Syndrome: Assessment of Feasibility and Safety.
Led by Centre Hospitalier Régional d'Orléans · Updated on 2025-12-30
32
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Acute Respiratory Distress Syndrome (ARDS) is a serious lung condition caused by widespread lung damage in patients with certain risk factors. Researchers are comparing two positioning methods for patients with moderate to severe ARDS: the established prone position (lying face down) and a newer verticalization technique that raises patients to a 55° angle in bed. The study aims to assess if verticalization is safe, feasible, and has similar effects on oxygen levels as the prone position. This is a crossover study where each patient experiences both positioning techniques in random order. The verticalization is done in seven progressive steps, starting from lying flat to 55° upright, then back down. Each prone position period lasts 12 to 20 hours and must be started 4 to 8 hours after the previous positioning. Patients are assigned to one of four sequences combining prone and verticalization treatments to avoid carry-over effects. Participants will undergo arterial blood gas tests before, immediately after, and one hour following each positioning to measure oxygenation. Chest ultrasounds and monitoring for any adverse events will also be performed. The main outcome is the percentage of patients who can safely reach the 55° vertical position without serious side effects. The study will last about one month, with continuous safety monitoring and detailed data collection during the treatment periods.
CONDITIONS
Brief Title
Early Verticalization of the Patient With Acute Respiratory Distress Syndrome: Assessment of Feasibility and Safety.
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adults older than 18 years
- Diagnosed with ARDS with PaO2/FiO2 ratio less than 150 within 24 hours prior to screening
- Hemodynamically stable with mean arterial pressure over 65 mmHg, maintained without vasopressors or with low-dose norepinephrine (less than 0.5 µg/kg/min)
- Have received at least 1 but fewer than 5 prone position sessions
- Under continuous intravenous sedation or not responding to simple orders
- Written consent from support person or family
You will not qualify if you...
- Pregnant women (positive pregnancy test during screening)
- Breastfeeding women
- Adults under legal protection (protected majors)
- Body weight over 198 kg (bed load limit)
- Amputation of one or both lower limbs at or above the tibial level
- Contraindications to standing such as fractures or neurological instability with intracranial pressure sensors or shunts
- Deep vein thrombosis in lower limbs with anticoagulation for less than 48 hours
- Hemodynamic instability with mean arterial pressure below 65 mmHg despite norepinephrine at or above 0.5 µg/kg/min
- Persons under guardianship or trusteeship
- Patients without health insurance coverage
- Moribund patients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 4 consecutive positioning periods, each lasting 12 to 20 hours with 4 to 8 hours between sessions
Participants undergo a randomized sequence of positioning techniques including prone positioning (PP) and verticalization to a 55° bed inclination. Each positioning period lasts between 12 and 20 hours, with 4 to 8 hours between sessions. The verticalization maneuver progresses in 7 steps from flat to 55° inclination and back, each step lasting up to 15 minutes.
Multiple positioning sessions over several days
Follow-up
Duration - Up to 1 month
Participants are monitored for safety and adverse events after completing the positioning sequences. Assessments include arterial gasometry and chest ultrasound at specified times around positioning maneuvers.
Assessments at the beginning, end, and one hour after each positioning maneuver
Trial Site Locations
Total: 1 location
1
CHR d'ORLEANS
Orléans, France
Actively Recruiting
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Research Team
A
Aurélie DESPUJOLS
E
Elodie POUGOUE TOUKO
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
OTHER
Number of Arms
4
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