An interventional study of Exposure of the patient to a novel air mattress. and Exposure of the patient to a conventional foam mattress. in Skin Abnormalities, Skin; Injury, Superficial and Skin; Ulcer, Decubitus, sponsored by Simon Annaheim. Completed at 1 site in Switzerland. Open to participants aged 10 Days to 6 Months. Per ClinicalTrials.gov, last updated 2025-01-13.
Sponsored by Simon Annaheim · Not applicable, Interventional, and Supportive care
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.
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.
39 studies on the registry are indexed under Skin Abnormalities; 7 are open to participants now.
This study's enrollment of 23 is below the median of 39 across 26 interventional studies indexed under Skin Abnormalities.
Browse Skin Abnormalities studies →Simon Annaheim is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
see information provided in the "Arms" section (experimental)
see information provided in the "Arms" section (active comparator)
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).
Time frame: 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).
Time frame: after 60 minutes of exposure to the mattress
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.
Time frame: 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)
Quantification of contact are between the patient and the mattress surfaces.
Time frame: after 60 minutes of exposure to the mattress
Difference in stress assessment by means of heart rate
Measurement of heart rate obtained from clinical routine patient surveillance.
Time frame: baseline
Stress assessment by means of heart rate
Measurement of heart rate obtained from clinical routine patient surveillance.
Time frame: after 60 minutes of exposure to the mattress
Stress assessment by means of respiratory rate
Measurement of respiratory rate obtained from clinical routine patient surveillance.
Time frame: baseline
Stress assessment by means of respiratory rate
Measurement of respiratory rate obtained from clinical routine patient surveillance.
Time frame: after 60 minutes of exposure to the mattress
Stress assessment by means of blood pressure (mean arterial pressure)
Measurement of blood pressure obtained from clinical routine patient surveillance.
Time frame: baseline
Stress assessment by means of blood pressure (mean arterial pressure)
Measurement of blood pressure obtained from clinical routine patient surveillance.
Time frame: after 60 minutes of exposure to the mattress
Stress assessment by means of blood oxygen saturation
Measurement of blood oxygen saturation obtained from clinical routine patient surveillance.
Time frame: baseline
Stress assessment by means of blood oxygen saturation
Measurement of blood oxygen saturation obtained from clinical routine patient surveillance.
Time frame: after 60 minutes of exposure to the mattress
Stress assessment by means of body temperature
Measurement of body temperature obtained from clinical routine patient surveillance.
Time frame: baseline
Stress assessment by means of body temperature
Measurement of body temperature obtained from clinical routine patient surveillance.
Time frame: after 60 minutes of exposure to the mattress
Comfort assessment by means of a visual analogue scale
Quantification of comfort level ranging from 0 \[very uncomfortable\] to 10 \[very comfortable\].
Time frame: baseline
Comfort assessment by means of a visual analogue scale
Quantification of comfort level ranging from 0 \[very uncomfortable\] to 10 \[very comfortable\].
Time frame: after 60 minutes of exposure to the mattress
Stress assessment by means of a visual analogue scale
Quantification of stress level ranging from 0 \[totally relaxed\] to 10 \[very stressed\].
Time frame: baseline
Stress assessment by means of a visual analogue scale
Quantification of stress level ranging from 0 \[totally relaxed\] to 10 \[very stressed\].
Time frame: after 60 minutes of exposure to the mattress
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.
Time frame: baseline
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.
Time frame: after 60 minutes of exposure to the mattress
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).
Time frame: baseline
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).
Time frame: after 60 minutes of exposure to the mattress
Skin perfusion assessment by means of capillary refill time
Assessment of the capillary refill time according to Jevon and Gallier (2020).
Time frame: baseline
Skin perfusion assessment by means of capillary refill time
Assessment of the capillary refill time according to Jevon and Gallier (2020).
Time frame: after 60 minutes of exposure to the mattress
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
Time frame: baseline
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
Time frame: after 60 minutes of exposure to the mattress
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.
Time frame: baseline
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.
Time frame: after 60 minutes of exposure to the mattress
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.
Time frame: baseline
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.
Time frame: after 60 minutes of exposure to the mattress
Plan to share: Yes — It is intended to publish the study in an open-access journal by December 2024. With this, the raw data of the interface pressure and contact area measurements will be made available upon request and fulfilling the access criteria as indicated below.
Supporting information: Study protocol, Statistical analysis plan
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.
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.