Assessment of an Innovative Air Mattress On Critically Ill Infants

Skin Abnormalities Clinical Trial

— Prepicare  

Official title:

Assessment of an Innovative Air Mattress On Critically Ill Infants

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06425068
• Other study ID #: Empa PSP 5211.02071
• Status: Recruiting
• Phase: N/A
• Start date: May 7, 2024
• Est. completion date: July 2024

Study information

• Verified date: May 2024
• Source: Empa, Swiss Federal Laboratories for Materials Science and Technology
• Contact: Simon Annaheim, PhD
• Phone: +41 58 765 77 68
• Email: simon.annaheim[@]empa.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 26
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Days to 6 Months

Eligibility

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

Related Conditions & MeSH terms

• Pressure Ulcer
• Skin Abnormalities

Intervention

Device:
• Exposure of the patient to a novel air mattress.
see information provided in the "Arms" section (experimental)
• Exposure of the patient to a conventional foam mattress.
see information provided in the "Arms" section (active comparator)

Locations

Country	Name	City	State
Switzerland	University Children's Hospital Zurich	Zurich

Sponsors (2)

Lead Sponsor	Collaborator
Simon Annaheim	University Children's Hospital, Zurich

Country where clinical trial is conducted

Switzerland, 

References & 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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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)	Quantification of contact are between the patient and the mattress surface.	baseline
Secondary	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)	Quantification of contact are between the patient and the mattress surfaces.	after 60 minutes of exposure to the mattress
Secondary	Difference in stress assessment by means of heart rate	Measurement of heart rate obtained from clinical routine patient surveillance.	baseline
Secondary	Stress assessment by means of heart rate	Measurement of heart rate obtained from clinical routine patient surveillance.	after 60 minutes of exposure to the mattress
Secondary	Stress assessment by means of respiratory rate	Measurement of respiratory rate obtained from clinical routine patient surveillance.	baseline
Secondary	Stress assessment by means of respiratory rate	Measurement of respiratory rate obtained from clinical routine patient surveillance.	after 60 minutes of exposure to the mattress
Secondary	Stress assessment by means of blood pressure (mean arterial pressure)	Measurement of blood pressure obtained from clinical routine patient surveillance.	baseline
Secondary	Stress assessment by means of blood pressure (mean arterial pressure)	Measurement of blood pressure obtained from clinical routine patient surveillance.	after 60 minutes of exposure to the mattress
Secondary	Stress assessment by means of blood oxygen saturation	Measurement of blood oxygen saturation obtained from clinical routine patient surveillance.	baseline
Secondary	Stress assessment by means of blood oxygen saturation	Measurement of blood oxygen saturation obtained from clinical routine patient surveillance.	after 60 minutes of exposure to the mattress
Secondary	Stress assessment by means of body temperature	Measurement of body temperature obtained from clinical routine patient surveillance.	baseline
Secondary	Stress assessment by means of body temperature	Measurement of body temperature obtained from clinical routine patient surveillance.	after 60 minutes of exposure to the mattress
Secondary	Comfort assessment by means of a visual analogue scale	Quantification of comfort level ranging from 0 [very uncomfortable] to 10 [very comfortable].	baseline
Secondary	Comfort assessment by means of a visual analogue scale	Quantification of comfort level ranging from 0 [very uncomfortable] to 10 [very comfortable].	after 60 minutes of exposure to the mattress
Secondary	Stress assessment by means of a visual analogue scale	Quantification of stress level ranging from 0 [totally relaxed] to 10 [very stressed].	baseline
Secondary	Stress assessment by means of a visual analogue scale	Quantification of stress level ranging from 0 [totally relaxed] to 10 [very stressed].	after 60 minutes of exposure to the mattress
Secondary	Pain assessment by means of the questionnaire "Bern pain score for newborns - Revised (BSN-R)"	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.	baseline
Secondary	Pain assessment by means of the questionnaire "Bern pain score for newborns - Revised (BSN-R)"	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.	after 60 minutes of exposure to the mattress
Secondary	Unrest assessment by means of the Richmond Agitation-Sedation Scale (RASS) questionnaire	Values range from -1 (sleepy) to 0 (attentive and calm) to +4 (belligerent).	baseline
Secondary	Unrest assessment by means of the Richmond Agitation-Sedation Scale (RASS) questionnaire	Values range from -1 (sleepy) to 0 (attentive and calm) to +4 (belligerent).	after 60 minutes of exposure to the mattress
Secondary	Skin perfusion assessment by means of capillary refill time	Assessment of the capillary refill time according to Jevon and Gallier (2020).	baseline
Secondary	Skin perfusion assessment by means of capillary refill time	Assessment of the capillary refill time according to Jevon and Gallier (2020).	after 60 minutes of exposure to the mattress
Secondary	Skin assessment according to standard clinical procedure	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	baseline
Secondary	Skin assessment by means of questionnaire	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	after 60 minutes of exposure to the mattress
Secondary	Delirium assessment by means of the Cornell Assessment of Pediatric Delirium score (CAPD)	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.	baseline
Secondary	Delirium assessment by means of the Cornell Assessment of Pediatric Delirium score (CAPD)	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.	after 60 minutes of exposure to the mattress
Secondary	Withdrawal assessment by means of the Sophia Observation Withdrawal Symptoms scale (SOS)	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.	baseline
Secondary	Withdrawal assessment by means of the Sophia Observation Withdrawal Symptoms scale (SOS)	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.	after 60 minutes of exposure to the mattress