Chronic Immobile PatientsNCT01402765
Interface Pressure Measures for Matresses: Nimbus 3 Versus Summit
A study testing Summit first and Nimbus 3 first in people with Chronic Immobile Patients, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
The primary objective of this study is to compare the distribution of pressure among pressure interfaces between two anti-bedsore mattresses. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Chronic Immobile Patients
- What is being tested?
- Summit first and Nimbus 3 first
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2012to 11 Apr 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Chronic Immobile Patients
- Being tested
- Summit first, Nimbus 3 first
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Summit firstDevice
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 firstDevice
Pressure measurements are first taken on the Nimbus 3 mattress. The patient is then transferred to a Summit mattress, and the measures are repeated.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Summit first) | Active comparator | 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. Receives: Device: Summit first |
| Group 2 (Nimbus 3 first) | Active comparator | 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. Receives: Device: Nimbus 3 first |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 1
Secondary outcomes (5)
Mean interface pressure (mmHg)
Mean interface pressure (mmHg)
Measured: Day 1
Minimum interface pression (mmHg)
Minimum interface pression (mmHg)
Measured: Day 1
Maximum interface pressure (mmHg)
Maximum interface pressure (mmHg)
Measured: Day 1
Percentage of data capture time where the pressures are changing (%)
Percentage of data capture time where the pressures are changing (%)
Measured: Day 1
Matress tolerance: yes/no
Tolerance of mattress: yes/no
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2011 (estimated)
- Study startMar 2012
- Primary completion11 Apr 2012
- Study completion11 Apr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Immobile PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emilie Viollet, MD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01402765
- Sponsor's protocol ID
- LOCAL/2011/EV-06
- Other IDs
- 2011-A00697-34
- Status last verified
- Mar 2015
- First submitted
- 25 Jul 2011
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 34598852
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interface Pressure Measures for Matresses: a Randomized, Cross-over, Non-inferiority Study Comparing the Nimbus 3 Versus Summit Matresses
- ClinicalTrials.gov ID
- NCT01402765
- Acronym / sponsor ID
- LOCAL/2011/EV-06
- Conditions
- Chronic Immobile Patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- 11 Apr 2012 (actual)
- Study completion
- 11 Apr 2012 (actual)
- First posted
- 26 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to compare the distribution of pressure among pressure interfaces between two anti-bedsore mattresses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Summit first) | Active comparator | Device: Summit firstIn 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. |
| Group 2 (Nimbus 3 first) | Active comparator | Device: Nimbus 3 firstIn 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Summit firstPressure measurements are first taken on the Summit mattress. The patient is then transferred to a Nimbus 3 mattress, and the measures are repeated. | Device | Group 1 (Summit first) |
| Nimbus 3 firstPressure measurements are first taken on the Nimbus 3 mattress. The patient is then transferred to a Summit mattress, and the measures are repeated. | Device | Group 2 (Nimbus 3 first) |
Primary outcome
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
5 secondary outcomes
Mean interface pressure (mmHg)
Time frame: Day 1
Minimum interface pression (mmHg)
Time frame: Day 1
Maximum interface pressure (mmHg)
Time frame: Day 1
Percentage of data capture time where the pressures are changing (%)
Time frame: Day 1
Matress tolerance: yes/no
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Results publication: PubMed 34598852de 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emilie Viollet, MD principal investigator
Centre Hospitalier Universitaire de Nīmes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Summit first and Nimbus 3 first in people with Chronic Immobile Patients, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of data capture time at < 30 mmHg (%) (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01402765, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.