Assessing the safety and feasibility of upright positioning for patients with acute respiratory distress syndrome.
Early Verticalization of the Patient With Acute Respiratory Distress Syndrome: Assessment of Feasibility and Safety.
This study is testing if sitting patients up at an angle can help those with Acute Respiratory Distress Syndrome breathe better and avoid complications compared to lying flat.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Régional d'Orléans Academic / other |
| Locations | 1 site (Orléans) |
| Trial ID | NCT04472260 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the feasibility and safety of a new positioning technique called verticalization for patients suffering from Acute Respiratory Distress Syndrome (ARDS). The study involves a cross-over design where patients will alternate between the traditional prone position and the new verticalization technique, which involves gradually raising the patient's bed to a 55° angle. The trial will monitor various clinical responses, including arterial blood gas measurements and chest ultrasounds, to assess the impact of these positioning techniques on patient outcomes. The goal is to determine if verticalization can improve oxygenation and reduce complications associated with the prone position.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with ARDS and a PaO2/FiO2 ratio of less than 150.
Not a fit: Patients who are pregnant, breastfeeding, or have contraindications to standing will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance patient recovery and reduce complications in ARDS management.
How similar studies have performed: While the prone position has been widely studied and shown to decrease mortality in ARDS, the specific approach of verticalization is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Orléans
- CHR d'ORLEANS — Orléans, France (Recruiting)
Study contacts
- Principal investigator: Mai-ANh NAY, Dr — CHR Orléans
- Study coordinator: Aurélie DESPUJOLS
- Email: aurelie.despujols@chr-orleans.fr
- Phone: +33238744071
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.