Assessment of an Innovative Air Mattress on Critically Ill Infants

NCT ID: NCT06425068

Last Updated: 2025-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-07
• Study Completion Date: 2024-09-10

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 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.

Conditions

Skin Abnormalities; Skin; Injury, Superficial; Skin; Ulcer, Decubitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Investigation of contact pressure distribution in a novel air mattress

Exposure of the patient to the novel air mattress. Recording of interface pressure and contact area between the patient and the air mattress for one hour.

Regular measurement of vital signs and comfort and assessment of risk to develop side effects, particularly skin pressure injuries.

Group Type: EXPERIMENTAL

Exposure of the patient to a novel air mattress.

Intervention Type: DEVICE

see information provided in the "Arms" section (experimental)

Investigation of contact pressure distribution in a conventional foam mattress

Exposure of the patient to the conventional foam mattress. Recording of interface pressure and contact area between the patient and the foam mattress for one hour.

Regular measurement of vital signs and comfort and assessment of risk to develop side effects, particularly skin pressure injuries.

Group Type: ACTIVE_COMPARATOR

Exposure of the patient to a conventional foam mattress.

Intervention Type: DEVICE

see information provided in the "Arms" section (active comparator)

Interventions

Exposure of the patient to a novel air mattress.

see information provided in the "Arms" section (experimental)

Intervention Type: DEVICE

Exposure of the patient to a conventional foam mattress.

see information provided in the "Arms" section (active comparator)

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Informed consent signed by the legal guardian
• Admitted to the pediatric intensive care unit (PICU)
• Age: late preterm (>34 gestational age) up to 6 months
• Admission at least 24 hours to PICU prior to intervention
• Presence/availability of at least one parent/legal guardian

Exclusion Criteria

• Life threatening condition
• Patients who cannot be positioned in supine position
• Skin injury at body area in contact with support surface
• Patients with congenital skin disorders
• Patients with omphalocele or gastroschisis
• Newborns with peripartum asphyxia and hypothermia therapy
• Language communication difficulties with the legal guardians
• Surgical patients on the day of surgery
• birth weight <1250g

• Minimum Eligible Age: 10 Days
• Maximum Eligible Age: 6 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Children's Hospital, Zurich

OTHER

Sponsor Role: collaborator

Simon Annaheim

OTHER

Sponsor Role: lead

Responsible Party

Simon Annaheim

Principle Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Barbara Brotschi, Prof

Role: PRINCIPAL_INVESTIGATOR

Universitäts-Kinderspital Zürich, Zurich

Locations

University Children's Hospital Zurich

Zurich, Canton of Zurich, Switzerland

Countries

Switzerland

References

Jevon P, Gallier H. How to measure capillary refill time in patients who are acutely ill. Nursing Times [online]. 2020; 116(8): 29-30.

Reference Type: BACKGROUND

Other Identifiers

Empa PSP 5211.02071

Identifier Type: -

Identifier Source: org_study_id