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Effectiveness of Platform-Based Lateralization Therapy in Reducing Interface Pressure Between The Patient And The Support Surface

RecruitingNAAges 18 Years - anyAllUniversity of Sao Paulo General Hospital
NCT06819943 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Pressure injury (PI) is characterized as damage to the skin and/or underlying tissues resulting from sustained pressure or a combination of pressure and shear forces between the patient and the support surface. Prolonged pressure is a well-established risk factor in the development of PIs. Frequent repositioning and routine patient care have been recognized for decades as integral components of PI prevention and treatment protocols. The duration of interface pressure is as critical as its magnitude. When interface pressure exceeds the mean capillary blood pressure, blood flow can be compromised, leading to ischemia in affected areas, which may progress to necrosis if sustained over time. Furthermore, it is widely accepted in the literature that tissue becomes at risk when interface pressure exceeds 30 to 32 mmHg. In this context, continuous lateral rotation therapy (CLRT) offers a pote

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📋 Eligibility rules (as published)
Inclusion Criteria * Adult and elderly patients, aged 18 years or older; * Patients under controlled or assisted mechanical ventilation, not yet eligible for weaning. Exclusion Criteria * Requirement of norepinephrine \> 0.3 mcg/kg/min or mean arterial pressure \< 60 mmHg, despite the use of vasopressor agents; * Cardiac arrhythmias or bleeding leading to hemodynamic instability; * Neurological diseases or symptoms; * Spinal cord injury, such as paraplegia; * Cardiac pacemaker dependence; * Contraindications to hypercapnia, such as intracranial hypertension or acute coronary syndrome; * Air leakage from chest drains, presence of pneumothorax or undrained subcutaneous emphysema; * Presence of pre-existing pressure injuries in bony prominences (sacral, occipital, scapular, or calcaneal) at admission; * Medical refusal to include the patient in the study.
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What it tests

  • Automated Lateral Rotation Therapy
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Where

1 site
Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade São Paulo
São Paulo, Brazil
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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