Clinical trial NCT06819943: Effectiveness of Platform-Based Lateralization Therapy in Reducing Interface Pressure Between the Patient and the Support Surface
Official title: Effectiveness of Platform-Based Lateralization Therapy in Reducing Interface Pressure Between the Patient and the Support Surface
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Respiratory Insufficiency
Pressure Injury
Intensive Care Medicine
ARDS
Keywords: Continuous Lateral Rotation Therapy
Rotation Therapy
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2025-02-11
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Comparison between two groups: control (manual change) and intervention (automatic change)
Primary purpose: PREVENTION

Brief summary: 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.

This study hypothesizes that Platform-Based Lateralization (Platform-Based Lateral Tilt) is effective in reducing interface pressure between the patient and the support surface and in decreasing the incidence of pressure injuries and pulmonary complications.

Detailed description: The objective of this study is to evaluate the effectiveness of Platform-Based Lateralization Therapy (Platform-Based Lateral Tilt) in reducing interface pressure between the patient and the support surface, compared to manual decubitus repositioning performed by the nursing team. To achieve this, a randomized clinical trial will be conducted, enrolling adult and elderly patients on invasive mechanical ventilation with a risk score for pressure injury development of 18 or lower.

Both groups will utilize the Linet Multicare bed, equipped with the Simbioso mattress featuring Continuous Low Pressure (CLP) and Microclimate Management (MCM) modes. The bed allows both manual and automatic lateral tilting of the platform, with a maximum angulation of 30° along the axial axis.

In the intervention group, patients will receive Platform-Based Lateral Tilt Therapy combined with CLP and MCM. The control group will receive CLP and MCM in addition to the standard pressure injury prevention strategies already implemented in the unit.

Patients will be monitored continuously for up to 72 hours using the ForeSite PT Patient Turn System with Continuous Pressure Imaging (CPI) from XSENSOR Technology Corporation, electrical impedance tomography (Enlight, Timpel, Brazil), and Lifemed's Integrare system, which records the degrees of lateralization of the bed and the patient's position. Hemodynamic parameters will be monitored using the Edwards LifeSciences IV 1000 Platform.

Interface pressure data will be analyzed using the ForeSite system software, with continuous pressure sampling at a rate of 1 Hz, and further processed using the XSENSOR Pressure Exposure Analyzer Tool (PEAT). Additional data will be collected in a database developed using REDCap software, and statistical analyses will be performed using R Statistical Software.

Outcome Variables: The primary outcome variable will be interface pressure and pressure distribution, measured as peak pressure, the absolute number of sensors with pressure readings greater than 32/40 mmHg over time, pressure gradient, and mean interface pressure.

Hypotheses:

Platform-Based Lateral Tilt Therapy will significantly reduce sustained interface pressure between the patient and the support surface at lateralized angles of 10°, 20°, and 30° compared to the supine position.

Reducing interface pressure will contribute to a lower incidence of pressure injuries in ICU patients.

Repositioning using Platform-Based Lateralization Therapy will not negatively impact the patient's hemodynamic status.

Frequent patient mobilization in bed will contribute to a reduced incidence of Ventilator-Associated Pneumonia (VAP).

Eligibility criteria: Inclusion Criteria:

* Adult and elderly patients, aged 18 years or over;
* Patients at risk of developing LP (Braden Scale score less than or equal to 18);
* Patient under controlled/assisted mechanical ventilation not yet eligible for weaning.

Exclusion Criteria:

* Age equal to or greater than 75 years;
* Norepinephrine need \> 1mcg/kg/min or mean arterial pressure \< 60 mmHg;
* Cardiac arrhythmias;
* Neurological illnesses or symptoms, such as a history of seizures;
* Cardiac pacemaker dependence;
* Air leak through chest tubes, pneumothorax or subcutaneous emphysema drained;
* Presence of previous PI during admission.

Primary outcomes:
measure: Interface Pressure
timeFrame: The pressure sensor will be placed from the beginning to the end of the protocol, during the 72-hour period. Readings will be taken in the last minute of each position.
Secondary outcomes:
measure: Driving Pressure
timeFrame: Readings will be taken in the last minute of each position, after the plethysmogram displayed on the EIT has stabilized. During the 72 hour period.
measure: Pressure Injury
timeFrame: At the end of the 72 hours the patient will be monitored.
measure: End Expiratory Lung Volume
timeFrame: Readings will be taken in the last minute of each position, after the plethysmogram displayed on the EIT has stabilized. During the 72 hour period.
measure: Ventilatory Distribution
timeFrame: Readings will be taken in the last minute of each position, after the plethysmogram displayed on the EIT has stabilized. During the 72 hour period.
measure: Plateau Pressure
timeFrame: Readings will be taken in the last minute of each position, after the plethysmogram displayed on the EIT has stabilized. During the 72 hour period.
measure: Effort perceived by Nursing professionals
timeFrame: At the end of the 72 hours of protocol.
measure: Esophageal reflux
timeFrame: It uses a pH probe that will be kept continuously during the 72-hour protocol.
measure: Diastolic Blood Pressure
timeFrame: At the end of each position. During the 72 hour monitoring period.
measure: Mean Arterial Pressure
timeFrame: At the end of each position. During the 72 hour monitoring period.
measure: Systolic Blood Pressure
timeFrame: At the end of each position. During the 72 hour monitoring period.
measure: Heart Rate
timeFrame: At the end of each position. During the 72 hour monitoring period.
measure: Hypotension Prediction Index (HPI)
timeFrame: Evaluated changes throughout the protocol. During the 72 hour monitoring period.
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade São Paulo
state: SP
Study officials:
References:
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citation: Anderson R, Kleiber C, Greiner J, Comried L, Zimmerman M. Interface pressure redistribution on skin during continuous lateral rotation therapy: A feasibility study. Heart Lung. 2016 May-Jun;45(3):237-43. doi: 10.1016/j.hrtlng.2016.02.003. Epub 2016 Mar 15.