Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06425068
Status:
RECRUITING
Last Update Posted:
2024-05-22
First Post:
2024-04-11
Brief Title:
Assessment of an Innovative Air Mattress On Critically Ill Infants
Sponsor:
Simon Annaheim
Organization:
Empa Swiss Federal Laboratories for Materials Science and Technology
Study Overview
Official Title:
Assessment of an Innovative Air Mattress On Critically Ill Infants
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Prepicare
Brief 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
Detailed 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 hasnt 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 patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None