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Search / Trial NCT06819943

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

Launched by UNIVERSITY OF SAO PAULO GENERAL HOSPITAL · Feb 4, 2025

Trial Information

Current as of June 27, 2025

Recruiting

Keywords

Continuous Lateral Rotation Therapy Rotation Therapy

ClinConnect Summary

This clinical trial is studying a new therapy called Platform-Based Lateralization, which aims to reduce pressure injuries (PIs) in patients who are critically ill and on mechanical ventilation. Pressure injuries can harm the skin and underlying tissues when there is too much pressure on certain areas of the body for too long. The researchers believe that this new method of gently rotating patients could help lower the pressure on their skin and potentially reduce the number of pressure injuries and breathing complications.

To participate in this study, patients need to be 18 years or older and considered at risk for pressure injuries, meaning they have a specific score on a scale used to assess their risk. However, some patients may not be eligible if they are older than 75, have certain heart or neurological issues, or have already developed a pressure injury during their hospital stay. Those who join the trial can expect to receive close monitoring and care while the researchers evaluate how well this new therapy works in preventing pressure injuries.

Gender

ALL

Eligibility criteria

  • 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.

About University Of Sao Paulo General Hospital

The University of São Paulo General Hospital (Hospital das Clínicas da Universidade de São Paulo) is a leading clinical research institution in Brazil, renowned for its commitment to advancing medical knowledge and patient care. As an academic hospital affiliated with one of the largest and most prestigious universities in Latin America, it integrates clinical practice, education, and research. The hospital conducts a wide array of clinical trials across various medical disciplines, aiming to develop innovative therapies and improve healthcare outcomes. With a multidisciplinary team of healthcare professionals and access to cutting-edge facilities, the University of São Paulo General Hospital is dedicated to fostering scientific advancements and addressing critical health challenges.

Locations

Sao Paulo, Sp, Brazil

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported