Clinical trial NCT06425068: Assessment of an Innovative Air Mattress on Critically Ill Infants
Official title: Assessment of an Innovative Air Mattress on Critically Ill Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Abnormalities
Skin; Injury, Superficial
Skin; Ulcer, Decubitus
Keywords: Air mattress
Skin interface pressure
Skin contact area
Lying comfort
Lead sponsor: Empa, Swiss Federal Laboratories for Materials Science and Technology
Sponsor class: OTHER
Collaborators: name: University Children's Hospital, Zurich
First posted: 2024-05-22
Enrollment: 23
Sex: ALL
Minimum age (years): 10
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The study population comprises 26 patients being exposed to the conventional foam mattress (active comparator) and the novel air mattress (experimental) for one hour each in a random order. Interface pressure and contact are will be measured by means of a pressure mattress applied on top of the support systems. The patient comfort will be assessed objectively based on vital sign readings and subjectively based on questionnaire filled by professional care personnel and parents.
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Interface pressure resulting from the exposure of patients to the supportive structures as measured by a pressure sensitive mat (xsensor, LX100:100.160.05, XSENSOR Technology Corporation, Calgary, Canada).
timeFrame: baseline
measure: Interface pressure resulting from the exposure of patients to the supportive structures as measured by a pressure sensitive mat (xsensor, LX100:100.160.05, XSENSOR Technology Corporation, Calgary, Canada).
timeFrame: after 60 minutes of exposure to the mattress
Secondary outcomes:
measure: Contact area resulting from the exposure of patients to the supportive structures as detected by a pressure sensitive mat (xsensor, LX100:100.160.05, XSENSOR Technology Corporation, Calgary, Canada)
timeFrame: baseline
measure: Contact area resulting from the exposure of patients to the supportive structures as detected by a pressure sensitive mat (xsensor, LX100:100.160.05, XSENSOR Technology Corporation, Calgary, Canada)
timeFrame: after 60 minutes of exposure to the mattress
measure: Difference in stress assessment by means of heart rate
timeFrame: baseline
measure: Stress assessment by means of heart rate
timeFrame: after 60 minutes of exposure to the mattress
measure: Stress assessment by means of respiratory rate
timeFrame: baseline
measure: Stress assessment by means of respiratory rate
timeFrame: after 60 minutes of exposure to the mattress
measure: Stress assessment by means of blood pressure (mean arterial pressure)
timeFrame: baseline
measure: Stress assessment by means of blood pressure (mean arterial pressure)
timeFrame: after 60 minutes of exposure to the mattress
measure: Stress assessment by means of blood oxygen saturation
timeFrame: baseline
measure: Stress assessment by means of blood oxygen saturation
timeFrame: after 60 minutes of exposure to the mattress
measure: Stress assessment by means of body temperature
timeFrame: baseline
measure: Stress assessment by means of body temperature
timeFrame: after 60 minutes of exposure to the mattress
measure: Comfort assessment by means of a visual analogue scale
timeFrame: baseline
measure: Comfort assessment by means of a visual analogue scale
timeFrame: after 60 minutes of exposure to the mattress
measure: Stress assessment by means of a visual analogue scale
timeFrame: baseline
measure: Stress assessment by means of a visual analogue scale
timeFrame: after 60 minutes of exposure to the mattress
measure: Pain assessment by means of the questionnaire "Bern pain score for newborns - Revised (BSN-R)"
timeFrame: baseline
measure: Pain assessment by means of the questionnaire "Bern pain score for newborns - Revised (BSN-R)"
timeFrame: after 60 minutes of exposure to the mattress
measure: Unrest assessment by means of the Richmond Agitation-Sedation Scale (RASS) questionnaire
timeFrame: baseline
measure: Unrest assessment by means of the Richmond Agitation-Sedation Scale (RASS) questionnaire
timeFrame: after 60 minutes of exposure to the mattress
measure: Skin perfusion assessment by means of capillary refill time
timeFrame: baseline
measure: Skin perfusion assessment by means of capillary refill time
timeFrame: after 60 minutes of exposure to the mattress
measure: Skin assessment according to standard clinical procedure
timeFrame: baseline
measure: Skin assessment by means of questionnaire
timeFrame: after 60 minutes of exposure to the mattress
measure: Delirium assessment by means of the Cornell Assessment of Pediatric Delirium score (CAPD)
timeFrame: baseline
measure: Delirium assessment by means of the Cornell Assessment of Pediatric Delirium score (CAPD)
timeFrame: after 60 minutes of exposure to the mattress
measure: Withdrawal assessment by means of the Sophia Observation Withdrawal Symptoms scale (SOS)
timeFrame: baseline
measure: Withdrawal assessment by means of the Sophia Observation Withdrawal Symptoms scale (SOS)
timeFrame: after 60 minutes of exposure to the mattress
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Children's Hospital Zurich
Study officials:
affiliation: Universitäts-Kinderspital Zürich, Zurich
name: Barbara Brotschi, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jevon P, Gallier H. How to measure capillary refill time in patients who are acutely ill. Nursing Times [online]. 2020; 116(8): 29-30.