Interface Pressure Measures for Matresses: Nimbus 3 Versus Summit

Centre Hospitalier Universitaire de Nīmes

Status: Completed

Conditions: Chronic Immobile Patients

Treatments: Device: Nimbus 3 first; Device: Summit first

Study type: Interventional

Funder types: Other

Identifiers

NCT01402765

LOCAL/2011/EV-06

2011-A00697-34 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 31 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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31 participants in 2 patient groups

Group 1 (Summit first)

Active Comparator group

Description:

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.

Treatment:

Device: Summit first

Group 2 (Nimbus 3 first)

Active Comparator group

Description:

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.

Treatment:

Device: Nimbus 3 first