Interface Pressure Measures for Matresses: Nimbus 3 Versus Summit

Not Applicable

Completed

• Conditions: Chronic Immobile Patients
• Interventions: Device: Nimbus 3 first; Device: Summit first

• Registration Number: NCT01402765
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-07-25
• Study First Submitted QC: 2011-07-25
• Study First Posted: 2011-07-26
• Study Start: 2012-03
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-25
• Last Update Posted: 2015-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2 (Nimbus 3 first)	Nimbus 3 first	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.
Group 1 (Summit first)	Summit first	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Centre Hospitalier Universitaire de Nîmes; 🇫🇷 Nîmes Cedex 09, Gard, France