NCT07213739

A Trial to Investigate the New Caulis Pro® Low Air Loss (LAL) System

A Laboratory Trial to Investigate the Biomechanical and Physiological Responses to Prolonged Lying Postures During CLP When Combined With Pulsation Therapy on Caylis Pro® Low Air Loss (LAL) System

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Arjo AB · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

Summary

Investigation of biomechanical and physiological functions of laying on a new mattress in healthy volunteers.

Detailed description

This trial primary aims to investigate the biomechanical (interface pressure) and physiological (microvascular function) responses to prolonged lying postures during CLP when combined with pulsation therapy on a product not yet placed on the market (Caylis Pro® LAL System). A secondary aim is to compare the frequency and amplitude of different pulsation modes with respect to the biomechanical and physiological responses at the participant-support surface interface.

Conditions

• Health Adult Subjects
• Pressure Injury Prevention

Interventions

Type	Name	Description
DEVICE	CLP and pulsation	As an alternative to manual repositioning, advanced air mattress systems have been introduced to periodically relieve support pressures. A number of measurements have been used to examine the performance of support surfaces. As an example, interface pressure measurements between the individual and the support surface have been extensively used in both lab-based and clinical studies . We are now investigation the functions to reduce pressure in our new Caylis mattress

Timeline

• Start date: 2025-09-30
• Primary completion: 2026-03-30
• Completion: 2026-04-30
• First posted: 2025-10-09
• Last updated: 2025-10-09