NCT01402765
Completed
Not Applicable
Interface Pressure Measures for Matresses: a Randomized, Cross-over, Non-inferiority Study Comparing the Nimbus 3 Versus Summit Matresses
Centre Hospitalier Universitaire de Nīmes1 site in 1 country31 target enrollmentMarch 1, 2012
ConditionsChronic Immobile Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Immobile Patients
- Sponsor
- Centre Hospitalier Universitaire de Nīmes
- Enrollment
- 31
- Locations
- 1
- Primary Endpoint
- Percentage of data capture time at < 30 mmHg (%)
- Status
- Completed
- Last Updated
- 5 months ago
Overview
Brief Summary
The primary objective of this study is to compare the distribution of pressure among pressure interfaces between two anti-bedsore mattresses.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Percentage of data capture time at < 30 mmHg (%)
Time Frame: Day 1
Percentage of data capture time with a pressure redistribution index measured at the sacrum and buttox at \< 30 mmHg
Secondary Outcomes
- Minimum interface pression (mmHg)(Day 1)
- Maximum interface pressure (mmHg)(Day 1)
- Mean interface pressure (mmHg)(Day 1)
- Percentage of data capture time where the pressures are changing (%)(Day 1)
- Matress tolerance: yes/no(Day 1)
Study Sites (1)
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