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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Sao Paulo General Hospital

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 volunteers

Qualifiers

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

Design model

Crossover

Treatments tested in this trial

  • Automated Lateral Rotation Therapy

    Procedure/Surgery

    Platform-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

25 Participants
are divided into 1 treatment group
Group A: Automated Lateral Rotation TherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Pressure measurements correspond to the mean value during the 10 minutes of each position, for both head-of-bed inclinations. In the extended monitoring phase, data are collected continuously for 2 hours on each side.

Secondary outcomes

1

Driving Pressure

Driving Pressure (cmH2O) will be measured using the information provided by the EIT that uses the movement equation

Time frame
Readings will be taken immediately before changing to the next position, after stabilization in each position, during the protocol.
2

End Expiratory Lung Volume

Will be measured using the information provided by the Electrical Tomography Impedance

Time frame
Readings will be taken immediately before changing to the next position, after stabilization in each position, during the protocol.
3

Ventilatory Distribution

Will be measured using the information provided by the Electrical Tomography Impedance

Time frame
Readings will be taken immediately before changing to the next position, after stabilization in each position, during the protocol.
4

Plateau Pressure

Plateau Pressure( cmH2O) will be measured using the information provided by the EIT that uses the movement equation.

Time frame
Readings will be taken immediately before changing to the next position, after stabilization in each position, during the protocol.

Other outcomes

Sponsors and contacts

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