Acute Respiratory Distress Syndrome Clinical Trial
— STAND_ARDS1Official title:
Early Verticalization of the Patient With Acute Respiratory Distress Syndrome: Assessment of Feasibility and Safety.
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. However, this technique is not without deleterious effects such as ventilator-associated pneumonia, endotracheal tube obstruction, development of pressure ulcers, and increased workload for the caregivers. There are other positioning techniques such as the "upright" position, which simulates a relative verticality, which allows to increase the effects of the prone position and even in some patients to improve oxygenation without the PP in the acute phase of ARDS. However, given the revolution caused by the use of PP in ARDS patients, verticalization have not been studied in more details. Today, there is a bed on the market that allows patients to be truly upright without having to transfer them to a tilt table. The investigators believe that raising ARDS patients in the acute phase is safe and feasible in routine practice. In this research protocol comparing PP and verticalization in a crossover trial design in acute ARDS patients, the investigators want to show that this technique can be safe and feasible, with the same effects on oxygenation as PP.
Status | Recruiting |
Enrollment | 32 |
Est. completion date | October 15, 2024 |
Est. primary completion date | October 15, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | CHR d'ORLEANS | Orléans |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Régional d'Orléans |
France,
Umbrello M, Formenti P, Bolgiaghi L, Chiumello D. Current Concepts of ARDS: A Narrative Review. Int J Mol Sci. 2016 Dec 29;18(1):64. doi: 10.3390/ijms18010064. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of patients who were able to reach 55° of verticalization without serious adverse events (with a complete listing of all adverse events). | To demonstrate the feasibility and safety in routine practice of the verticalization technique for patients with moderate to severe ARDS in the acute phase. | Month 1 | |
Secondary | PaO2/FiO2 ratio at one hour from the end of the maneuver | To show that verticalization of ARDS patients has the same effects on oxygenation (PaO2/FiO2 ratio) as PP.
In this crossover trial, each sequence of four treatment periods, beginning at time of randomization, will last a maximum of 75,5 hours for each patient. The last assessment will occur at a maximum of 76,5 hours from randomisation. |
Hour 76 | |
Secondary | Quasi-static compliance in (ml/cmH2O) before, at the end and one hour after each positioning technique | To evaluate the impact of the positioning maneuver on quasi-static thoracopulmonary compliance.
In this crossover trial, each sequence of four treatment periods, beginning at time of randomization, will last a maximum of 75,5 hours for each patient. The last assessment will occur at a maximum of 76,5 hours from randomisation. |
Hour 76 | |
Secondary | Lung Reaeration Score at 1 hour from the end of the maneuver | To compare the re-ventilation of the pulmonary territories at one hour of the session (PP or verticalization) evaluated by thoracic ultrasound.
In this crossover trial, each sequence of four treatment periods, beginning at time of randomization, will last a maximum of 75,5 hours for each patient. The last assessment will occur at a maximum of 76,5 hours from randomisation. |
Hour 76 |
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