- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06425068
Assessment of an Innovative Air Mattress On Critically Ill Infants (Prepicare)
Study Overview
Status
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Simon Annaheim, PhD
- Phone Number: +41 58 765 77 68
- Email: simon.annaheim@empa.ch
Study Contact Backup
- Name: Barbara Brotschi, Prof
- Phone Number: +41 44 266 71 71
- Email: barbara.brotschi@kispi.uzh.ch
Study Locations
-
-
-
Zurich, Switzerland, 8032
- Recruiting
- University Children's Hospital Zurich
-
Contact:
- Barbara Brotschi, Prof
- Phone Number: +41 44 266 71 71
- Email: barbara.brotschi@kispi.uzh.ch
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Investigation of contact pressure distribution in 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. |
see information provided in the "Arms" section (experimental)
|
Active Comparator: Investigation of contact pressure distribution in 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. |
see information provided in the "Arms" section (active comparator)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
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).
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).
|
after 60 minutes of exposure to the mattress
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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
|
Quantification of contact are between the patient and the mattress surfaces.
|
after 60 minutes of exposure to the mattress
|
Difference in stress assessment by means of heart rate
Time Frame: baseline
|
Measurement of heart rate obtained from clinical routine patient surveillance.
|
baseline
|
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.
|
after 60 minutes of exposure to the mattress
|
Stress assessment by means of respiratory rate
Time Frame: baseline
|
Measurement of respiratory rate obtained from clinical routine patient surveillance.
|
baseline
|
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.
|
after 60 minutes of exposure to the mattress
|
Stress assessment by means of blood pressure (mean arterial pressure)
Time Frame: baseline
|
Measurement of blood pressure obtained from clinical routine patient surveillance.
|
baseline
|
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.
|
after 60 minutes of exposure to the mattress
|
Stress assessment by means of blood oxygen saturation
Time Frame: baseline
|
Measurement of blood oxygen saturation obtained from clinical routine patient surveillance.
|
baseline
|
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.
|
after 60 minutes of exposure to the mattress
|
Stress assessment by means of body temperature
Time Frame: baseline
|
Measurement of body temperature obtained from clinical routine patient surveillance.
|
baseline
|
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.
|
after 60 minutes of exposure to the mattress
|
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].
|
baseline
|
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].
|
after 60 minutes of exposure to the mattress
|
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].
|
baseline
|
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].
|
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
|
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
|
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.
|
after 60 minutes of exposure to the mattress
|
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).
|
baseline
|
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).
|
after 60 minutes of exposure to the mattress
|
Skin perfusion assessment by means of capillary refill time
Time Frame: baseline
|
Assessment of the capillary refill time according to Jevon and Gallier (2020).
|
baseline
|
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).
|
after 60 minutes of exposure to the mattress
|
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
|
baseline
|
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
|
after 60 minutes of exposure to the mattress
|
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.
|
baseline
|
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.
|
after 60 minutes of exposure to the mattress
|
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.
|
baseline
|
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.
|
after 60 minutes of exposure to the mattress
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Barbara Brotschi, Prof, Universitäts-Kinderspital Zürich, Zurich
Publications and helpful links
General 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 record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Empa PSP 5211.02071
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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