Pressure Injury
Conditions
Keywords
Pressure injury, Life support system, Beds, Prevention
Brief summary
The aim of the study is to determine the clinical value of using a powered alternating pressure air mattress (P-APAM) in the prevention of pressure injury (PI) in patients at medium to high risk. This study is noncomparative, observational study. Patients older than 18 years of age, with a medium to high risk of PI, without PI, up during the day, and lying more than 15 hours a day on a specific P-APAM were included. The study was conducted in nursing homes, and in long-stay geriatrics department. Patients are followed up for 35 days. The use of the P-APAM is associated with the usual PI prevention measures. The primary outcome is the percentage of patients who developed between day 0 and day 35 at least one PI of at least stage 2 on the sacrum, spine, or heel. Secondary endpoints are patient assessments of comfort, caregiver satisfaction, mattress noise level, and mattress safety.
Interventions
Patients with a medium to high risk of pressure injury, without pressure injury, up during the day, will ly a on a specific P-APAM (DOMUS 4 /AUTO)
Sponsors
Clin-Experts
Wellell France
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patient over 18 years old * Patient with a medium to high risk of developing pressure ulcers (clinical judgment and a score of \[10 to 14\] on the Braden scale (6 (maximum risk) to 23 (no risk)) * Patient without pressure injury on the day of inclusion * Patient up during the day, lying between 3 p.m. and 8 p.m. a day on a Domus 4 / AUTO mattress * Patient with a weight \< 200 kg * Patient (or a trusted third party) having been informed of the study and agreeing to participate
Exclusion criteria
* Patient at end of life (estimated life expectancy less than 6 months) * Malnourished patient according to the french health authority (Haute Autorité de la santé) definition\* \* For adults under 70: * weight loss ≥ 5% in one month or ≥ 10% in six months * or body mass index (BMI) ≤ 18.5 (excluding constitutional thinness) * for adults over 70: * weight loss ≥ 5% in one month or ≥ 10% in six months * or BMI ≤ 21 * or Mini Nutritional Assessment (MNA) ≤ 17 (/30) * or albuminemia \< 35 g/L
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| percentage of patients who developed at least one stage 2 pressure injury | 35 days after installation on the mattress (at day 35) | Percentage of patients who developed at least one stage 2 PI of the sacrum, backbone, or heel (areas of support when lying down) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients who developed a o pressure injury (any stage), other than those of the sacrum, backbone, or heel between | 35 days after installation on the mattress (at day 35) | — |
| Assessment by the patient (or family or staff in the case of incapacity) of the comfort of the mattress (general comfort, stability) | 35 days after installation on the mattress (at day 35) | On a scale from 0 (not satisfied at all) to 4 (very satisfied) |
| Assessment by the nursing staff with the use of the mattress (implementation, cleaning maintenance turning, changing to a sitting position) | 35 days after installation on the mattress (at day 35) | On a scale from 0 (not satisfied at all) to 4 (very satisfied) |
| Assessment of the degree of maceration | 35 days after installation on the mattress (at day 35) | On a scale from 1 (constantly moist) to 4 rarely moist |
| Assessment of mattress safety | At day 35 | by collecting any adverse event or mattress malfunction during the follow up |
Countries
France
Outcome results
None listed