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Completed

NCT Number: NCT06425068

Assessment of an Innovative Air Mattress on Critically Ill Infants

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.

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Key information

Conditions

Skin Abnormalities Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Pressure Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Skin; Injury, Superficial Skin; Ulcer, Decubitus Wounds and Injuries

Age range

10 day–6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Children's Hospital Zurich

Zurich, Canton of Zurich, 8032, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exposure of the patient to a novel air mattress.

Device

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

Exposure of the patient to a conventional foam mattress.

Device

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

Primary outcomes

  1. 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).

    Time frame: baseline

    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).

  2. 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).

    Time frame: 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 outcomes

  1. 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)

    Time frame: baseline

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

  2. 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)

    Time frame: after 60 minutes of exposure to the mattress

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

  3. Difference in stress assessment by means of heart rate

    Time frame: baseline

    Measurement of heart rate obtained from clinical routine patient surveillance.

  4. Stress assessment by means of heart rate

    Time frame: after 60 minutes of exposure to the mattress

    Measurement of heart rate obtained from clinical routine patient surveillance.

  5. Stress assessment by means of respiratory rate

    Time frame: baseline

    Measurement of respiratory rate obtained from clinical routine patient surveillance.

  6. Stress assessment by means of respiratory rate

    Time frame: after 60 minutes of exposure to the mattress

    Measurement of respiratory rate obtained from clinical routine patient surveillance.

  7. Stress assessment by means of blood pressure (mean arterial pressure)

    Time frame: baseline

    Measurement of blood pressure obtained from clinical routine patient surveillance.

  8. Stress assessment by means of blood pressure (mean arterial pressure)

    Time frame: after 60 minutes of exposure to the mattress

    Measurement of blood pressure obtained from clinical routine patient surveillance.

  9. Stress assessment by means of blood oxygen saturation

    Time frame: baseline

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

  10. Stress assessment by means of blood oxygen saturation

    Time frame: after 60 minutes of exposure to the mattress

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

  11. Stress assessment by means of body temperature

    Time frame: baseline

    Measurement of body temperature obtained from clinical routine patient surveillance.

  12. Stress assessment by means of body temperature

    Time frame: after 60 minutes of exposure to the mattress

    Measurement of body temperature obtained from clinical routine patient surveillance.

  13. Comfort assessment by means of a visual analogue scale

    Time frame: baseline

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

  14. Comfort assessment by means of a visual analogue scale

    Time frame: after 60 minutes of exposure to the mattress

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

  15. Stress assessment by means of a visual analogue scale

    Time frame: baseline

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

  16. Stress assessment by means of a visual analogue scale

    Time frame: after 60 minutes of exposure to the mattress

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

  17. Pain assessment by means of the questionnaire "Bern pain score for newborns - Revised (BSN-R)"

    Time frame: baseline

    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.

  18. Pain assessment by means of the questionnaire "Bern pain score for newborns - Revised (BSN-R)"

    Time frame: 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.

  19. Unrest assessment by means of the Richmond Agitation-Sedation Scale (RASS) questionnaire

    Time frame: baseline

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

  20. Unrest assessment by means of the Richmond Agitation-Sedation Scale (RASS) questionnaire

    Time frame: after 60 minutes of exposure to the mattress

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

  21. Skin perfusion assessment by means of capillary refill time

    Time frame: baseline

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

  22. Skin perfusion assessment by means of capillary refill time

    Time frame: after 60 minutes of exposure to the mattress

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

  23. Skin assessment according to standard clinical procedure

    Time frame: baseline

    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

  24. Skin assessment by means of questionnaire

    Time frame: after 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

  25. Delirium assessment by means of the Cornell Assessment of Pediatric Delirium score (CAPD)

    Time frame: baseline

    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.

  26. Delirium assessment by means of the Cornell Assessment of Pediatric Delirium score (CAPD)

    Time frame: 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.

  27. Withdrawal assessment by means of the Sophia Observation Withdrawal Symptoms scale (SOS)

    Time frame: baseline

    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.

  28. Withdrawal assessment by means of the Sophia Observation Withdrawal Symptoms scale (SOS)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Simon Annaheim

Other

Collaborators

  • University Children's Hospital, Zurich

Registry information

Acronym: Prepicare

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 22, 2024
Registry last updated
Jan 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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