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

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.

Study Overview

• Status: Recruiting
• Conditions: Respiratory Insufficiency; ARDS; Pressure Injury; Intensive Care Medicine
• Intervention / Treatment: Procedure: Automated Lateral Rotation Therapy

Detailed Description

The objective of this study is to evaluate the effectiveness of Automated Lateral Rotation Therapy in reducing interface pressure between the patient and the support surface, considering different head-of-bed elevations, in mechanically ventilated patients. This is a multidimensional approach, assessing the effects on respiratory, hemodynamic, and gastroesophageal parameters.

This is a single-center, intra-individual crossover randomized clinical trial, using a Latin square allocation model, conducted in an intensive care unit.

The study will compare the effects of automated platform lateralization at 15 degrees and 30 degrees, combined with a 10-degree head-of-bed elevation, to the supine position with a 30-degree head-of-bed elevation, focusing on the reduction of interface pressure. Lateral tilting will be performed to both sides (right and left) according to prior randomization. Each position will be maintained for 10 minutes, followed by a 10-minute washout period in the supine position before transitioning to the next condition.

Additionally, after completing the crossover assessments, a subgroup of six patients will undergo an extended monitoring phase. In this step, the lateralized position at 30 degrees with a 30-degree head-of-bed elevation will be maintained for two continuous hours on each side (right and left) to assess the temporal evolution of interface pressure, determining whether pressure values remain stable or tend to increase over time.

The intervention will be conducted using the Linet Multicare bed, equipped with the Symbioso mattress, which features Continuous Low Pressure (CLP) and Microclimate Management (MCM) modes. This system enables manual or automated lateral tilting of the entire bed platform up to 30 degrees on the axial axis. The CLP mode provides automatic, continuous low-pressure redistribution, minimizing interface pressures regardless of weight distribution or patient movement. The MCM mode includes a vapor-impermeable cover that reduces skin moisture and heat, supporting skin integrity and preventing maceration.

Monitoring Procedures Interface pressure monitoring will be performed using the ForeSite Intelligent Surface (Xsensor, Canada), a sensor network embedded in a mattress cover composed of 6136 sensing cells distributed over an area of 762 by 1880 millimeters, with a spatial resolution of 31.75 millimeters. The system provides continuous pressure acquisition at 3 Hz, operating in the range of 5 to 200 mmHg (0.7 to 36.6 kPa), with an accuracy of plus or minus 2 mmHg. During the protocol, interface pressure will be monitored continuously with real-time visual feedback displayed on a bedside LCD monitor, allowing visualization of pressure redistribution throughout the interventions.

Pulmonary monitoring will be conducted using the ENLIGHT (Timpel, model 2100, Brazil), which utilizes a 32-electrode belt placed around the thorax at the mid-axillary line to provide real-time monitoring of ventilation distribution through electrical impedance tomography (EIT).

Hemodynamic monitoring will be performed using the FloTrac system coupled with the EV1000 platform (Edwards Lifesciences, Irvine, California, USA), connected to a peripheral arterial catheter, enabling continuous measurement of cardiac output, cardiac index, stroke volume, stroke volume variation, and blood pressure parameters.

Gastroesophageal pH monitoring will be carried out using the AL-4 pH monitoring system (ALACER, Brazil), which includes an antimony pH probe with an external reference electrode placed on the patient's thoracic skin to continuously measure esophageal pH levels.

Primary Hypothesis Automated Lateral Rotation Therapy promotes a reduction in interface pressure, assessed by peak pressure, mean pressure, and the absolute count of sensors recording pressure above 40 mmHg. Additionally, it is hypothesized that the extent of this reduction varies depending on the degree of lateral tilt and head-of-bed elevation, with lower degrees potentially being more effective for pressure redistribution.

Secondary Hypotheses Automated lateral positioning improves respiratory mechanics, contributing to better ventilation and oxygenation.

Adverse hemodynamic effects are minimized when using controlled tilt angles. Automated lateral rotation does not increase the incidence of gastroesophageal reflux.

Primary Outcome Reduction in peak pressure in the sacral region.

Secondary Outcomes Peak pressure mean pressure in the occipital, scapular, and calcaneal regions. Mean pressure in the sacral, occipital, scapular, and calcaneal regions. Number of sensors with pressure above 32, 40, and 60 mmHg in the sacral, occipital, scapular, and calcaneal regions.

Respiratory parameters including static compliance, driving pressure, oxygenation, and volumetric capnography.

Hemodynamic parameters including heart rate, blood pressure, cardiac output, cardiac index, stroke volume, and stroke volume variation.

Gastric pH variation during different positioning conditions. Adverse events including hypotension, accidental ventilator disconnection, respiratory discomfort, or significant gastroesophageal reflux.

Pre-intervention Procedures

Before starting the protocol, a standardized preparation process will be performed to ensure clinical stability, measurement accuracy, and consistency across all participants. The following procedures will be applied:

Closed-system suctioning to minimize secretion accumulation and avoid measurement artifacts.

Adjustment of ventilator settings in Volume-Controlled Ventilation (VCV) mode, using a square wave flow pattern. Respiratory rate (RR), inspiratory-to-expiratory ratio (I:E), fraction of inspired oxygen (FiO₂), and tidal volume (Vt) will be maintained according to baseline parameters.

Positive End-Expiratory Pressure (PEEP) will be maintained at the baseline value plus 2 cmH₂O during lateralization phases, to compensate for potential changes in thoracic mechanics and prevent derecruitment.

Placement of the interface pressure sensor (ForeSite PT, XSENSOR) will be performed by two trained professionals to ensure correct positioning, alignment, and reduction of artifacts.

Bed surface and sensor positioning will be inspected to eliminate any folds, misalignments, or sensor displacements that could interfere with pressure measurements.

The esophageal pH monitoring system will be zeroed and calibrated before each change in the head-of-bed elevation, ensuring accurate pH recording.

Proton pump inhibitor (PPI) administration will be rescheduled prior to the protocol, and the enteral feeding tube must be confirmed in a post-pyloric position, reducing the risk of reflux and interference with pH measurements.

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marcelo BP Amato, MD PhD; Phone Number: +55113061-7361; Email: marcelo.amato@hc.fm.usp.br
• Study Contact Backup: Name: Anne C Almeida de Sousa, PT; Phone Number: +5579998577249; Email: anne.sousa@usp.br

Study Locations

• Brazil
  • SP
    • Sao Paulo, SP, Brazil, 05403-900
      • Recruiting
      • Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade São Paulo
      • Contact: Anne CA Sousa; Phone Number: +5579998577249; Email: carolisalmeida14@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Automated Lateral Rotation Therapy; Experimental positioning protocol with automated lateral rotation. After allocation, each participant is assigned to an initial lateralization side (right or left) and an initial head-of-bed elevation (10 or 30 degrees). The protocol begins with arterial blood gas sampling in the supine position. Lateralization follows a fixed sequence of 15 and 30 degrees, held for 10 minutes each, first on the assigned side and then on the opposite side. Each position is separated by a 10-minute washout period in the supine position with the same head-of-bed elevation. After completing this sequence, the participant returns to the supine position, and the second head-of-bed elevation (the one not initially assigned) is applied, repeating the same sequence starting again from the same lateralization side assigned initially. At the end of the protocol, a post-protocol arterial blood gas is collected. All positions are maintained for 10 minutes each.

Procedure: Automated Lateral Rotation Therapy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Driving Pressure	Driving Pressure (cmH2O) will be measured using the information provided by the EIT that uses the movement equation	Readings will be taken immediately before changing to the next position, after stabilization in each position, during the protocol.
End Expiratory Lung Volume	Will be measured using the information provided by the Electrical Tomography Impedance	Readings will be taken immediately before changing to the next position, after stabilization in each position, during the protocol.
Ventilatory Distribution	Will be measured using the information provided by the Electrical Tomography Impedance	Readings will be taken immediately before changing to the next position, after stabilization in each position, during the protocol.
Plateau Pressure	Plateau Pressure( cmH2O) will be measured using the information provided by the EIT that uses the movement equation.	Readings will be taken immediately before changing to the next position, after stabilization in each position, during the protocol.
Esophageal reflux	Measurement with pH meter probe from Alacer Biomédica.	It uses a pH probe that will be kept continuously during the protocol. The pH curve over time is analyzed offline using the software provided by ALACER.
Diastolic Blood Pressure	The hemodynamics were assessed through Diastolic Blood Pressure using the multiparameter monitor DX-2020 (Dixtal, São Paulo, Brazil).	Readings will be taken immediately before changing to the next position, after stabilization in each position, during the protocol.
Mean Arterial Pressure	The hemodynamics were assessed through Mean Artial Pressure using the multiparameter monitor DX-2020 (Dixtal, São Paulo, Brazil).	Readings will be taken immediately before changing to the next position, after stabilization in each position, during the protocol.
Systolic Blood Pressure	The hemodynamics were assessed through Systolic Blood Pressure using the multiparameter monitor DX-2020 (Dixtal, São Paulo, Brazil).	Readings will be taken immediately before changing to the next position, after stabilization in each position, during the protocol.
Heart Rate	The hemodynamics were assessed through Heart Rate using the multiparameter monitor DX-2020 (Dixtal, São Paulo, Brazil).	Readings will be taken immediately before changing to the next position, after stabilization in each position, during the protocol.

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital

Publications and helpful links

General Publications

• Miranda DR, Nap R, de Rijk A, Schaufeli W, Iapichino G; TISS Working Group. Therapeutic Intervention Scoring System. Nursing activities score. Crit Care Med. 2003 Feb;31(2):374-82. doi: 10.1097/01.CCM.0000045567.78801.CC.
• Peterson MJ, Schwab W, van Oostrom JH, Gravenstein N, Caruso LJ. Effects of turning on skin-bed interface pressures in healthy adults. J Adv Nurs. 2010 Jul;66(7):1556-64. doi: 10.1111/j.1365-2648.2010.05292.x. Epub 2010 May 21.
• Ayello EA, Braden B. How and why to do pressure ulcer risk assessment. Adv Skin Wound Care. 2002 May-Jun;15(3):125-31; quiz 132-33. doi: 10.1097/00129334-200205000-00008.
• Bergstrom N, Braden BJ, Laguzza A, Holman V. The Braden Scale for Predicting Pressure Sore Risk. Nurs Res. 1987 Jul-Aug;36(4):205-10.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: January 22, 2025
• First Submitted That Met QC Criteria: February 4, 2025
• First Posted (Actual): February 11, 2025

Study Record Updates

• Last Update Posted (Actual): June 22, 2025
• Last Update Submitted That Met QC Criteria: June 17, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Continuous Lateral Rotation Therapy; Rotation Therapy
• Additional Relevant MeSH Terms: Wounds and Injuries; Respiratory Tract Diseases; Respiration Disorders; Skin Diseases; Skin Ulcer; Crush Injuries; Respiratory Insufficiency; Pressure Ulcer
• Other Study ID Numbers: 73162823.2.0000.0068

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No