Chronic Immobile Patients
Conditions
Brief summary
The primary objective of this study is to compare the distribution of pressure among pressure interfaces between two anti-bedsore mattresses.
Interventions
DEVICESummit first
Pressure measurements are first taken on the Summit mattress. The patient is then transferred to a Nimbus 3 mattress, and the measures are repeated.
DEVICENimbus 3 first
Pressure measurements are first taken on the Nimbus 3 mattress. The patient is then transferred to a Summit mattress, and the measures are repeated.
Sponsors
Centre Hospitalier Universitaire de Nīmes
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The patient must have given his/her informed and signed consent * The patient must be insured or beneficiary of a health insurance plan * Bedridden patients that still have some measure of mobility, or that can change beds with assistance. * Patients with symmetrical buttox support * Body mass index between 16 and 35
Exclusion criteria
* The patient is participating in another study * The patient is in an exclusion period determined by a previous study * The patient is under judicial protection, under tutorship or curatorship * The patient refuses to sign the consent * It is impossible to correctly inform the patient * Strict decubitus dorsal position is contra-indicated * State of agigation or non-cooperation * Asymetrical deformation of the spine or hips in the frontal plane * Bed sores present * Evolving cardiac pathology * Recent scar at a pressure interface * Deep vein thrombosis * Expected life span \< 24 weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of data capture time at < 30 mmHg (%) | Day 1 | Percentage of data capture time with a pressure redistribution index measured at the sacrum and buttox at \< 30 mmHg |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean interface pressure (mmHg) | Day 1 | Mean interface pressure (mmHg) |
| Minimum interface pression (mmHg) | Day 1 | Minimum interface pression (mmHg) |
| Maximum interface pressure (mmHg) | Day 1 | Maximum interface pressure (mmHg) |
| Percentage of data capture time where the pressures are changing (%) | Day 1 | Percentage of data capture time where the pressures are changing (%) |
| Matress tolerance: yes/no | Day 1 | Tolerance of mattress: yes/no |
Countries
France
Outcome results
None listed