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

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

This study is testing if a special bed can help prevent pressure injuries in critically ill adults and elderly patients on ventilators better than regular repositioning methods.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 25 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Sao Paulo General Hospital (Academic / other)
• Locations: 1 site (São Paulo, São Paulo)
• Trial ID: NCT06819943 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adult and elderly patients aged 18 years or older who are on mechanical ventilation and have a Braden Scale score of 18 or lower.

Not a fit: Patients aged 75 years or older, those requiring high doses of norepinephrine, or with certain cardiac or neurological conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the incidence of pressure injuries in critically ill patients, improving their overall care and recovery.

How similar studies have performed: Other studies have shown promise with similar continuous lateral rotation therapies, indicating potential for success in this approach.

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.

Where this trial is running

São Paulo, São Paulo

• 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

Conditions Respiratory Insufficiency; Pressure Injury; Intensive Care Medicine; ARDS; Continuous Lateral Rotation Therapy; Rotation Therapy