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Completed

NCT Number: NCT01402765

Interface Pressure Measures for Matresses: Nimbus 3 Versus Summit

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

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Key information

Conditions

Chronic Immobile Patients

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire de Nîmes

Nîmes, Gard, 30029, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Summit first

Device

Pressure measurements are first taken on the Summit mattress. The patient is then transferred to a Nimbus 3 mattress, and the measures are repeated.

Nimbus 3 first

Device

Pressure measurements are first taken on the Nimbus 3 mattress. The patient is then transferred to a Summit mattress, and the measures are repeated.

Primary outcomes

  1. 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

  1. Mean interface pressure (mmHg)

    Time frame: Day 1

    Mean interface pressure (mmHg)

  2. Minimum interface pression (mmHg)

    Time frame: Day 1

    Minimum interface pression (mmHg)

  3. Maximum interface pressure (mmHg)

    Time frame: Day 1

    Maximum interface pressure (mmHg)

  4. Percentage of data capture time where the pressures are changing (%)

    Time frame: Day 1

    Percentage of data capture time where the pressures are changing (%)

  5. Matress tolerance: yes/no

    Time frame: Day 1

    Tolerance of mattress: yes/no

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

Interface Pressure Measures for Matresses: a Randomized, Cross-over, Non-inferiority Study Comparing the Nimbus 3 Versus Summit Matresses

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jul 26, 2011
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.