Using a special bed to reduce pressure injuries in critically ill patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of Platform-Based Lateralization Therapy in reducing interface pressure between patients and their support surfaces compared to traditional manual repositioning. It involves a randomized clinical trial with adult and elderly patients on invasive mechanical ventilation who are at risk for pressure injuries. Participants will be monitored continuously for up to 72 hours using advanced pressure imaging and hemodynamic monitoring systems. The goal is to determine if the new therapy can better prevent pressure injuries in critically ill patients.

Why it matters

Who can join: the full rules

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.

Where it's running

• Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade São Paulo
  São Paulo, São Paulo, Brazil Recruiting

Study contacts

• Study coordinator: Marcelo BP Amato, MD PhD
• Email: marcelo.amato@hc.fm.usp.br
• Phone: +55113061-7361

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.