Clinical Trials Logo

Clinical Trial Summary

The permanent bedding of critically ill neonates and infants in the pediatric intensive care unit (PICU) for an extended amount of time can result in the development of pressure injuries (PI). PIs can form due to high and permanent local interface pressure induced by contact with bed surfaces or other medical devices. The currently used state-of-the-art support systems consist of conventional foam mattresses. In this study, the investigators explore the effect of a newly developed air mattress with regard to contact are and reduction in the average interface pressure in infants assigned to the pediatric intensive care unit of the childrens hospital in Zurich.


Clinical Trial Description

The permanent bedding of critically ill neonates and infants in the pediatric intensive care unit (PICU) for an extended amount of time can result in the development of pressure injuries (PI). This results in a further prolongation of the hospital stay, additional suffering of the patient, scarring, increased mortality and morbidity, and increased healthcare costs. Infants are at particular risk since their skin hasn't matured yet and is mechanically weak, and for example neonates lack a robust stratum corneum entirely. Furthermore, the thickness of their skin is reduced by 60% when compared to skin of adults. Thus, pressure cannot be equally absorbed leading to higher tissue internal stress. PIs can form due to high and permanent local interface pressure induced by contact with bed surfaces or other medical devices. Contact pressure can hamper blood flow in subcutaneous areas, increasing susceptibility for pressure injuries. While sophisticated equipment to manage the interface pressure and reduce the risk of developing pressure injuries is abundant for adults, very little is designed explicitly for neonates and infants. The currently available air mattresses are not being used due to safety concerns and impracticability. Furthermore, they are designed for infants from half a year of age and, thus, not considering the low body weight of premature babies or neonates. This is why the currently used conventional foam mattresses remain first choice. However, foam mattresses are designed for optimal support of a specific weight and, therefore, making them unsuitable for the use as a one-fits-all solution in a highly heterogenic patient cohort. In addition, compressed foam gets stiffer at compressed areas, increasing the local pressure impact and, thus, PI risk. On the other hand, the structures of the hereby-developed air mattress can freely move and optimally adjust to the patient's body shape. This increases contact area, reduces the average interface pressure and blunts local pressure peaks at the areas with the most indentation, ensuring a more homogenous pressure distribution at a lower level. This ultimately is expected to result in a lower PI incidence. As a side effect, lying comfort for the patient will be increased. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06425068
Study type Interventional
Source Empa, Swiss Federal Laboratories for Materials Science and Technology
Contact Simon Annaheim, PhD
Phone +41 58 765 77 68
Email simon.annaheim@empa.ch
Status Recruiting
Phase N/A
Start date May 7, 2024
Completion date July 2024

See also
  Status Clinical Trial Phase
Completed NCT04539886 - Comparative Study Between CellFX and Electrodessication in Sebaceous Hyperplasia (SH) Lesions N/A
Completed NCT01407770 - Genetic Susceptibility to Radiation-Induced Skin Reactions in Racial/Ethnic Groups of Patients With Breast Cancer
Completed NCT05619471 - VIO Imaging for Skin Tissue Assessment (VISTA) N/A
Not yet recruiting NCT05554523 - How Does Skin Tone Affect Quantitative Photoacoustic Imaging
Completed NCT04872946 - Topical and Oral Regimen for Skin Health N/A
Completed NCT04449159 - Efficacy of Vinh Wellness Collagen on Skin Health N/A
Completed NCT03002194 - Change in Skin Elasticity With RF and PEMF N/A
Enrolling by invitation NCT04934254 - THE NEWBORN SKIN ASSESSMENT ATTITUDE SCALE
Completed NCT05410964 - Non-Linear Imaging of Skin In Vivo
Completed NCT03612570 - Nano-Pulse Stimulation (NPS) in Sebaceous Hyperplasia N/A
Withdrawn NCT03862872 - Effects of Bend Beauty's Anti-Aging Formula on Inflammatory Markers N/A
Not yet recruiting NCT05923996 - Fractional Co2 Laser Versus Microbotox Injection in the Treatment of Wide Facial Pores: A Split Face Comparative Study Phase 1
Terminated NCT04253418 - Nano-Pulse Stimulation (NPS) in Sebaceous Hyperplasia Optimization Study N/A
Recruiting NCT04525521 - Hand Sanitizer Effects on the Skin Barrier
Withdrawn NCT01801878 - Pilot Study of Skin Quality Improvement After Adipose-drived Stem Cell Transfer in Irradiated Breasts N/A
Completed NCT00839280 - Moisturizing Effect of Two Dexpanthenol Formulations Phase 2
Completed NCT00520910 - Efficacy of Polypodium Leucotomos Extract Decreasing UVA Premutagenic and Photoaging Markers Phase 2
Completed NCT04813887 - Skin Diseases and Pregnancy: Which Heathcare Professionals ?
Recruiting NCT05641168 - A Pilot Evaluation Exploring New Adhesive Materials and Their Ability to Adhere to Abdominal and Peristomal Skin N/A
Terminated NCT01108523 - Evaluation of Effects of HP828-101 for Moisture Associated Skin Damage Phase 0