Assessment of an Innovative Air Mattress on Critically Ill Infants

NCT06425068 | Completed

• 1 other identifier: Empa PSP 5211.02071
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Air mattress; Skin interface pressure; Skin contact area; Lying comfort

Outcome Measures

Primary Outcomes (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).

  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).

  baseline

• 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).

  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).

  after 60 minutes of exposure to the mattress

Secondary Outcomes (28)

• 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)

  baseline

• 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

• Difference in stress assessment by means of heart rate

  baseline

• Stress assessment by means of heart rate

  after 60 minutes of exposure to the mattress

• Stress assessment by means of respiratory rate

  baseline

Study Arms (2)

Investigation of contact pressure distribution in a novel air mattress

EXPERIMENTAL

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.

Device: Exposure of the patient to a novel air mattress.

Investigation of contact pressure distribution in a conventional foam mattress

ACTIVE COMPARATOR

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.

Device: Exposure of the patient to a conventional foam mattress.

Interventions

Exposure of the patient to a novel air mattress. DEVICE

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

Investigation of contact pressure distribution in a novel air mattress

Exposure of the patient to a conventional foam mattress. DEVICE

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

Investigation of contact pressure distribution in a conventional foam mattress

Eligibility Criteria

• Age: 10 Days - 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Simon Annaheim: lead
• University Children's Hospital, Zurich: collaborator

Study Sites (1)

University Children's Hospital Zurich

Zurich, Canton of Zurich, 8032, Switzerland

Location

Related Publications (1)

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

  BACKGROUND

MeSH Terms

Conditions

Skin Abnormalities; Wounds and Injuries; Pressure Ulcer

Condition Hierarchy (Ancestors)

Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases; Skin and Connective Tissue Diseases; Skin Ulcer

Study Officials

• Barbara Brotschi, Prof

  Universitäts-Kinderspital Zürich, Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principle Investigator

Model Details: 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.

Study Record Dates

• First Submitted: April 11, 2024
• First Posted: May 22, 2024
• Study Start: May 7, 2024
• Primary Completion: September 10, 2024
• Study Completion: September 10, 2024
• Last Updated: January 13, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data as indicated in the plan description will be available upon publication of the data Data will be available for an unlimited period of time.
• Access Criteria: Data will be made available upon request for scientific analysis of the data. Research objectives and data analysis plan needs to be provided.

Locations

CH (1)