MedPath

Assessment of an Innovative Air Mattress on Critically Ill Infants

Not Applicable
Completed
Conditions
Skin; Ulcer, Decubitus
Skin Abnormalities
Skin; Injury, Superficial
Interventions
Device: Exposure of the patient to a novel air mattress.
Device: Exposure of the patient to a conventional foam mattress.
Registration Number
NCT06425068
Lead Sponsor
Simon Annaheim
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
23
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Investigation of contact pressure distribution in a novel air mattressExposure of the patient to 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.
Investigation of contact pressure distribution in a conventional foam mattressExposure of the patient to 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.
Primary Outcome Measures
NameTimeMethod
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).after 60 minutes of exposure to the mattress

Quantification of interface pressure between the patient and the mattress surfaces with emphasis on data of highest pressures (median for top 25% of pressure data observed; 4th quartile of pressure data).

Secondary Outcome Measures
NameTimeMethod
Skin assessment according to standard clinical procedurebaseline

Identification and localisation (nose, mouth, occipital, face, ear, back, leg, foot, heel, others) of skin irregularities and evaluation of severity of irregularity (redness, partial injury of skin layers, all skin layers affected, complete tissue loss) according to clinical routine

Delirium assessment by means of the Cornell Assessment of Pediatric Delirium score (CAPD)after 60 minutes of exposure to the mattress

Assessment of delirium indicators (eye contact, purposeful actions, awareness of surroundings, communication of needs, restlessness, refusal to be comforted, hypoactivity, response time) ranging from 0 points (not indicative for delirium) to 4 points (highly indicative for delirium). A delirium state is considered from a total value of \>8 points.

Stress assessment by means of blood oxygen saturationafter 60 minutes of exposure to the mattress

Measurement of blood oxygen saturation obtained from clinical routine patient surveillance.

Stress assessment by means of a visual analogue scaleafter 60 minutes of exposure to the mattress

Quantification of stress level ranging from 0 \[totally relaxed\] to 10 \[very stressed\].

Skin perfusion assessment by means of capillary refill timeafter 60 minutes of exposure to the mattress

Assessment of the capillary refill time according to Jevon and Gallier (2020).

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)after 60 minutes of exposure to the mattress

Quantification of contact are between the patient and the mattress surfaces.

Stress assessment by means of respiratory rateafter 60 minutes of exposure to the mattress

Measurement of respiratory rate obtained from clinical routine patient surveillance.

Stress assessment by means of body temperatureafter 60 minutes of exposure to the mattress

Measurement of body temperature obtained from clinical routine patient surveillance.

Skin assessment by means of questionnaireafter 60 minutes of exposure to the mattress

Identification and localisation (nose, mouth, occipital, face, ear, back, leg, foot, heel, others) of skin irregularities and evaluation of severity of irregularity (redness, partial injury of skin layers, all skin layers affected, complete tissue loss) according to clinical routine

Comfort assessment by means of a visual analogue scaleafter 60 minutes of exposure to the mattress

Quantification of comfort level ranging from 0 \[very uncomfortable\] to 10 \[very comfortable\].

Unrest assessment by means of the Richmond Agitation-Sedation Scale (RASS) questionnaireafter 60 minutes of exposure to the mattress

Values range from -1 (sleepy) to 0 (attentive and calm) to +4 (belligerent).

Difference in stress assessment by means of heart ratebaseline

Measurement of heart rate obtained from clinical routine patient surveillance.

Stress assessment by means of heart rateafter 60 minutes of exposure to the mattress

Measurement of heart rate obtained from clinical routine patient surveillance.

Stress assessment by means of blood pressure (mean arterial pressure)after 60 minutes of exposure to the mattress

Measurement of blood pressure obtained from clinical routine patient surveillance.

Pain assessment by means of the questionnaire "Bern pain score for newborns - Revised (BSN-R)"after 60 minutes of exposure to the mattress

Assessment of pain indicators (crying, facial expression, body tension, heart rate) ranging from 0 points (no pain indication) to 3 points (high pain indication). Total values \>5 points for premature babies and \>3 points for term babies is indicative for pain.

Withdrawal assessment by means of the Sophia Observation Withdrawal Symptoms scale (SOS)after 60 minutes of exposure to the mattress

Assessment of withdrawal indicators (autonomic dysfunction \[4 aspects\], overstimulation of the central nervous system \[9 aspects\], dysfunction of the gastrointestinal tract \[2 aspects\] ranging from 0 points (not detectable) to 1 point (detectable). A withdrawal state is considered from a total value of \>3 points.

Trial Locations

Locations (1)

University Children's Hospital Zurich

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Zurich, Switzerland

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