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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 18, 2014