About this trial
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 potential alternative for managing critically ill patients. CLRT involves continuous mechanical rotation of the patient in the lateral plane. However, its effects on skin integrity remain poorly understood. Despite the rationale behind and widespread recommendation of repositioning, the lack of robust evaluations on how repositioning impacts interface pressure creates uncertainty, underscoring the need for high-quality trials to assess different strategies for implementation.
Although lateralization is a pragmatic strategy for preventing pressure injuries, its use in critically ill patients requires an integrated assessment of respiratory, hemodynamic, and gastroesophageal effects. Therefore, this study proposes an innovative approach by evaluating, for the first time, the effectiveness of automated postural change with simultaneous monitoring of tissue integrity, pulmonary function, cardiovascular stability, and gastroesophageal protection. The aim is to optimize pressure injury prevention, improve pulmonary mechanics, ensure hemodynamic stability, and preserve gastroesophageal safety in critically ill patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult and elderly patients, aged 18 years or older;
Patients under controlled or assisted mechanical ventilation, not yet eligible for weaning.
Disqualifiers
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;
Trial design
Crossover
Treatments tested in this trial
Automated Lateral Rotation Therapy
Procedure/SurgeryPlatform-based automated lateral tilt system integrated into the Linet Multicare bed, which allows the entire bed platform to be tilted laterally up to 30 degrees along the axial axis, either manually or automatically. The system includes Continuous Low Pressure (CLP) mode, which automatically redistributes pressure to maintain low interface pressure, and Microclimate Management (MCM) to control moisture and heat at the skin interface. The intervention is designed to redistribute interface pressure as a preventive strategy against pressure injuries in critically ill patients.
Treatment groups
Trial outcomes
Primary outcomes
Interface Pressure
The interface pressure will be measured from the pressure reading made by the XSensor. The average pressure, peak pressure, and median pressure will be used for each region of the body. In addition to the absolute count of pressure sensors that made a reading above 32, 40 and 60mmHg.
Secondary outcomes
Driving Pressure
Driving Pressure (cmH2O) will be measured using the information provided by the EIT that uses the movement equation
End Expiratory Lung Volume
Will be measured using the information provided by the Electrical Tomography Impedance
Ventilatory Distribution
Will be measured using the information provided by the Electrical Tomography Impedance
Plateau Pressure
Plateau Pressure( cmH2O) will be measured using the information provided by the EIT that uses the movement equation.
Sponsors and contacts
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