Skin AbnormalitiesPrepicareNCT06425068
Assessment of an Innovative Air Mattress on Critically Ill Infants
A study testing Exposure of the patient to a novel air mattress. and Exposure of the patient to a conventional foam mattress. in people with Skin Abnormalities and Skin; Injury, Superficial, run by Simon Annaheim at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 10 days to 6 months
- Conditions the study is for
- Skin Abnormalities, Skin; Injury, Superficial, Skin; Ulcer, Decubitus
- What is being tested?
- Exposure of the patient to a novel air mattress. and Exposure of the patient to a conventional foam mattress.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteSwitzerland
- Study dates
- 7 May 2024to 10 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 days to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Language communication difficulties with the legal guardians
- Surgical patients on the day of surgery
- birth weight <1250g
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Children's Hospital Zurich
Zurich, Canton of Zurich, 8032
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). 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.
Read the 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.
- Being tested
- Exposure of the patient to a novel air mattress., Exposure of the patient to a conventional foam mattress.
- Keywords
- Air mattress, Skin interface pressure, Skin contact area, Lying comfort
- Medical subject headings
- Skin Abnormalities, Wounds and Injuries, Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Exposure of the patient to a conventional foam mattress. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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)
Quantification of contact are between the patient and the mattress surface.
Measured: 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.
Measured: 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.
Measured: baseline
Stress assessment by means of heart rate
Measurement of heart rate obtained from clinical routine patient surveillance.
Measured: 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.
Measured: baseline
Stress assessment by means of respiratory rate
Measurement of respiratory rate obtained from clinical routine patient surveillance.
Measured: 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.
Measured: baseline
Stress assessment by means of blood pressure (mean arterial pressure)
Measurement of blood pressure obtained from clinical routine patient surveillance.
Measured: 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.
Measured: baseline
Stress assessment by means of blood oxygen saturation
Measurement of blood oxygen saturation obtained from clinical routine patient surveillance.
Measured: 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.
Measured: baseline
Stress assessment by means of body temperature
Measurement of body temperature obtained from clinical routine patient surveillance.
Measured: 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].
Measured: baseline
Comfort assessment by means of a visual analogue scale
Quantification of comfort level ranging from 0 [very uncomfortable] to 10 [very comfortable].
Measured: 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].
Measured: baseline
Stress assessment by means of a visual analogue scale
Quantification of stress level ranging from 0 [totally relaxed] to 10 [very stressed].
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: baseline
Skin perfusion assessment by means of capillary refill time
Assessment of the capillary refill time according to Jevon and Gallier (2020).
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: after 60 minutes of exposure to the mattress
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2024
- Study start7 May 2024
- Primary completion10 Sep 2024
- Study completion10 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Skin AbnormalitiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Simon Annaheim
- Sponsor type
- University, hospital or other
- Collaborators
- University Children's Hospital, Zurich
- Responsible party
- Sponsor-investigator, Simon Annaheim, Empa, Swiss Federal Laboratories for Materials Science and Technology
- Investigators
- Barbara Brotschi, Prof, Principal investigator, Universitäts-Kinderspital Zürich, Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06425068
- Sponsor's protocol ID
- Empa PSP 5211.02071
- Acronym
- Prepicare
- Status last verified
- Jan 2025
- First submitted
- 11 Apr 2024
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Jevon P, Gallier H. How to measure capillary refill time in patients who are acutely ill. Nursing Times [online]. 2020; 116(8): 29-30.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of an Innovative Air Mattress on Critically Ill Infants
- ClinicalTrials.gov ID
- NCT06425068
- Acronym / sponsor ID
- Prepicare / Empa PSP 5211.02071
- Keywords
- Air mattress, Skin interface pressure, Skin contact area, Lying comfort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Simon AnnaheimUniversity, hospital or other
- Collaborators
- University Children's Hospital, Zurich
- Study start
- 7 May 2024 (actual)
- Primary completion
- 10 Sep 2024 (actual)
- Study completion
- 10 Sep 2024 (actual)
- First posted
- 22 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Investigation of contact pressure distribution in a novel air mattress | Experimental | Device: Exposure 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 mattress | Active comparator | Device: Exposure 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. |
Who may qualify
- Ages
- 10 days to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exposure of the patient to a novel air mattress.see information provided in the "Arms" section (experimental) | Device | Investigation of contact pressure distribution in a novel air mattress |
| Exposure of the patient to a conventional foam mattress.see information provided in the "Arms" section (active comparator) | Device | Investigation of contact pressure distribution in a conventional foam mattress |
Primary outcome
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).
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).
28 secondary outcomes
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
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
Difference in stress assessment by means of heart rate
Time frame: baseline
Stress assessment by means of heart rate
Time frame: after 60 minutes of exposure to the mattress
Stress assessment by means of respiratory rate
Time frame: baseline
Stress assessment by means of respiratory rate
Time frame: after 60 minutes of exposure to the mattress
Stress assessment by means of blood pressure (mean arterial pressure)
Time frame: baseline
Stress assessment by means of blood pressure (mean arterial pressure)
Time frame: after 60 minutes of exposure to the mattress
Stress assessment by means of blood oxygen saturation
Time frame: baseline
Stress assessment by means of blood oxygen saturation
Time frame: after 60 minutes of exposure to the mattress
Stress assessment by means of body temperature
Time frame: baseline
Stress assessment by means of body temperature
Time frame: after 60 minutes of exposure to the mattress
Comfort assessment by means of a visual analogue scale
Time frame: baseline
Comfort assessment by means of a visual analogue scale
Time frame: after 60 minutes of exposure to the mattress
Stress assessment by means of a visual analogue scale
Time frame: baseline
Stress assessment by means of a visual analogue scale
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)"
Time frame: baseline
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
Unrest assessment by means of the Richmond Agitation-Sedation Scale (RASS) questionnaire
Time frame: baseline
Unrest assessment by means of the Richmond Agitation-Sedation Scale (RASS) questionnaire
Time frame: after 60 minutes of exposure to the mattress
Skin perfusion assessment by means of capillary refill time
Time frame: baseline
Skin perfusion assessment by means of capillary refill time
Time frame: after 60 minutes of exposure to the mattress
Skin assessment according to standard clinical procedure
Time frame: baseline
Skin assessment by means of questionnaire
Time frame: after 60 minutes of exposure to the mattress
Delirium assessment by means of the Cornell Assessment of Pediatric Delirium score (CAPD)
Time frame: baseline
Delirium assessment by means of the Cornell Assessment of Pediatric Delirium score (CAPD)
Time frame: after 60 minutes of exposure to the mattress
Withdrawal assessment by means of the Sophia Observation Withdrawal Symptoms scale (SOS)
Time frame: baseline
Withdrawal assessment by means of the Sophia Observation Withdrawal Symptoms scale (SOS)
Time frame: after 60 minutes of exposure to the mattress
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
- BackgroundJevon P, Gallier H. How to measure capillary refill time in patients who are acutely ill. Nursing Times [online]. 2020; 116(8): 29-30.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara Brotschi, Prof principal investigator
Universitäts-Kinderspital Zürich, Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exposure of the patient to a novel air mattress. and Exposure of the patient to a conventional foam mattress. in people with Skin Abnormalities and Skin; Injury, Superficial, run by Simon Annaheim at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06425068, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2025.