Interface Pressure Measures for Matresses: Nimbus 3 Versus Summit

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

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

Study Overview

• Status: Completed
• Conditions: Chronic Immobile Patients
• Intervention / Treatment: Device: Summit first; Device: Nimbus 3 first

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Gard
    • Nîmes, Gard, France, 30029
      • Centre Hospitalier Universitaire de Nīmes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of data capture time at < 30 mmHg (%)	Percentage of data capture time with a pressure redistribution index measured at the sacrum and buttox at < 30 mmHg	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean interface pressure (mmHg)	Mean interface pressure (mmHg)	Day 1
Minimum interface pression (mmHg)	Minimum interface pression (mmHg)	Day 1
Maximum interface pressure (mmHg)	Maximum interface pressure (mmHg)	Day 1
Percentage of data capture time where the pressures are changing (%)	Percentage of data capture time where the pressures are changing (%)	Day 1
Matress tolerance: yes/no	Tolerance of mattress: yes/no	Day 1

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Emilie Viollet, MD, Centre Hospitalier Universitaire de Nīmes

Publications and helpful links

General Publications

• de Labachelerie C, Viollet E, Alonso S, Nouvel F, Bastide S, Blot M, Fagart W, Gelis A, Dupeyron A. Comparison of interface pressures in two dynamic pressure ulcer prevention supports (NIMBUS 3 and SUMMIT): A randomized controlled trial. J Tissue Viability. 2022 Feb;31(1):11-15. doi: 10.1016/j.jtv.2021.09.002. Epub 2021 Sep 11.

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): April 11, 2012
• Study Completion (Actual): April 11, 2012

Study Registration Dates

• First Submitted: July 25, 2011
• First Submitted That Met QC Criteria: July 25, 2011
• First Posted (Estimated): July 26, 2011

Study Record Updates

• Last Update Posted (Estimated): November 17, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: LOCAL/2011/EV-06; 2011-A00697-34 (Other Identifier: ANSM)