Interface Pressure Measures for Matresses: Nimbus 3 Versus Summit

Study Overview
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Brief Summary
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The primary objective of this study is to compare the distribution of pressure among pressure interfaces between two anti-bedsore mattresses.

Official Title
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Interface Pressure Measures for Matresses: a Randomized, Cross-over, Non-inferiority Study Comparing the Nimbus 3 Versus Summit Matresses

Conditions
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Chronic Immobile Patients

Intervention / Treatment
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* Device: Summit first
* Device: Nimbus 3 first


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1 (Summit first)<br>In Group 1 pressure measurements are first taken on the Summit mattress. The patient is then transferred to a Nimbus 3 mattress, and the measures are repeated. | Device: Summit first<br>* Pressure measurements are first taken on the Summit mattress. The patient is then transferred to a Nimbus 3 mattress, and the measures are repeated.<br>|
| Active Comparator: Group 2 (Nimbus 3 first)<br>In Group 2 pressure measurements are first taken on the Nimbus 3 mattress. The patient is then transferred to a Summit mattress, and the measures are repeated. | Device: Nimbus 3 first<br>* Pressure measurements are first taken on the Nimbus 3 mattress. The patient is then transferred to a Summit mattress, and the measures are repeated.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of data capture time at < 30 mmHg (%) | Percentage of data capture time with a pressure redistribution index measured at the sacrum and buttox at < 30 mmHg | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean interface pressure (mmHg) | Mean interface pressure (mmHg) | Day 1 | 
| Minimum interface pression (mmHg) | Minimum interface pression (mmHg) | Day 1 | 
| Maximum interface pressure (mmHg) | Maximum interface pressure (mmHg) | Day 1 | 
| Percentage of data capture time where the pressures are changing (%) | Percentage of data capture time where the pressures are changing (%) | Day 1 | 
| Matress tolerance: yes/no | Tolerance of mattress: yes/no | Day 1 |