Interface Pressure Measures for Matresses: Nimbus 3 Versus Summit

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01402765
First received: July 25, 2011
Last updated: March 3, 2014
Last verified: March 2014
  Purpose

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


Condition Intervention
Chronic Immobile Patients
Device: Summit first
Device: Nimbus 3 first

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Interface Pressure Measures for Matresses: a Randomized, Cross-over, Non-inferiority Study Comparing the Nimbus 3 Versus Summit Matresses

Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:
  • Percentage of data capture time at < 30 mmHg (%) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Percentage of data capture time with a pressure redistribution index measured at the sacrum and buttox at < 30 mmHg


Secondary Outcome Measures:
  • Mean interface pressure (mmHg) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Mean interface pressure (mmHg)

  • Minimum interface pression (mmHg) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Minimum interface pression (mmHg)

  • Maximum interface pressure (mmHg) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Maximum interface pressure (mmHg)

  • Percentage of data capture time where the pressures are changing (%) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Percentage of data capture time where the pressures are changing (%)

  • Matress tolerance: yes/no [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Tolerance of mattress: yes/no


Enrollment: 31
Study Start Date: March 2012
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group 1 (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.
Device: Summit 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.
Active Comparator: Group 2 (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.
Device: Nimbus 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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • Recent scar at a pressure interface
  • Deep vein thrombosis
  • Expected life span < 24 weeks
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01402765

Locations
France
Centre Hospitalier Universitaire de Nîmes
Nîmes Cedex 09, Gard, France, 30029
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Principal Investigator: Emilie Viollet, MD Centre Hospitalier Universitaire de Nîmes
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT01402765     History of Changes
Other Study ID Numbers: LOCAL/2011/EV-06, 2011-A00697-34
Study First Received: July 25, 2011
Last Updated: March 3, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Committee for the Protection of Personnes

ClinicalTrials.gov processed this record on April 23, 2014