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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Adult and elderly patients, aged 18 years or older;

• Patients under controlled or assisted mechanical ventilation, not yet eligible for weaning.

Locations
Other Locations
Brazil
Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade São Paulo
RECRUITING
São Paulo
Contact Information
Primary
Marcelo BP Amato, MD PhD
marcelo.amato@hc.fm.usp.br
+55113061-7361
Backup
Anne C Almeida de Sousa, PT
anne.sousa@usp.br
+5579998577249
Time Frame
Start Date: 2024-06-01
Estimated Completion Date: 2027-10
Participants
Target number of participants: 25
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: University of Sao Paulo General Hospital

This content was sourced from clinicaltrials.gov