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

NCT06819943 | Recruiting DMC

• 1 other identifier: 73162823.2.0000.0068
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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. 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.

Conditions

Respiratory Insufficiency; Pressure Injury; Intensive Care Medicine; ARDS

Keywords

Continuous Lateral Rotation Therapy; Rotation Therapy

Outcome Measures

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.

  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 (9)

• Driving Pressure

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

• End Expiratory Lung Volume

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

• Ventilatory Distribution

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

• Plateau Pressure

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

• Esophageal reflux

  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.

Study Arms (1)

Automated Lateral Rotation Therapy

EXPERIMENTAL

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

Interventions

Automated Lateral Rotation Therapy PROCEDURE

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.

Automated Lateral Rotation Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult and elderly patients, aged 18 years or older;
• Patients under controlled or assisted mechanical ventilation, not yet eligible for weaning.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade São Paulo

São Paulo, São Paulo, 05403-900, Brazil

RECRUITING

Related Publications (5)

• 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.

  PMID: 12576939 BACKGROUND

• 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.

  PMID: 20497272 BACKGROUND

• 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.

  PMID: 12055446 BACKGROUND

• 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.

  PMID: 3299278 BACKGROUND

• 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.

  PMID: 26992481 BACKGROUND

MeSH Terms

Conditions

Respiratory Insufficiency; Pressure Ulcer

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Marcelo BP Amato, MD PhD

CONTACT

+55113061-7361; marcelo.amato@hc.fm.usp.br

Anne C Almeida de Sousa, PT

CONTACT

+5579998577249; anne.sousa@usp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PHD

Model Details: Crossover study with Latin Square allocation. All participants are exposed to both automated lateral tilt and the supine reference position, in a balanced order, with washout periods between conditions.

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: February 11, 2025
• Study Start: June 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): October 1, 2027
• Last Updated: June 22, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)