Early Verticalization of the Patient With Acute Respiratory Distress Syndrome: Assessment of Feasibility and Safety.

Launched by CENTRE HOSPITALIER RÉGIONAL D'ORLÉANS · Jul 11, 2020

Keywords

ClinConnect Summary

The clinical trial titled "Early Verticalization of the Patient With Acute Respiratory Distress Syndrome" is exploring a new way to help patients with a serious lung condition called Acute Respiratory Distress Syndrome (ARDS). This trial is looking at whether raising patients to an upright position shortly after they develop ARDS can be safe and effective, similar to the established method of placing them on their stomachs (known as prone positioning). Researchers believe that this upright positioning could improve patients' oxygen levels while also reducing some risks associated with being on their stomachs, like pneumonia and pressure sores.

To join the study, participants must be adults over 18 years old who have been diagnosed with ARDS and have certain health conditions, such as stable blood pressure. However, some individuals, like pregnant women or those with certain health issues, will not be eligible. If chosen to participate, patients can expect to be placed in different positions during their treatment and monitored closely for safety and effectiveness. This trial is currently recruiting participants, and it aims to improve care for those suffering from ARDS.

Gender

ALL

Eligibility criteria

• Inclusion 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.
• Exclusion Criteria:
• • 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