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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-A00188-43 | Other Identifier | RCB number |
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methodological difficulties
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| Name | Class |
|---|---|
| Annie Bauer Confort | UNKNOWN |
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The main objective of this study is to compare the AIRSOFT DUO and the SENTRY 1200 constant pressure mattresses in terms of peak skin pressures measured at the sacral area.
The secondary objectives of the study are to compare the two devices in terms of:
A. body contact surface area. B. peak pressure at the heel area (combining right and left heels) C. occurrence of pressure ulcers anywhere on the body for 1 month D. patient comfort rated at 1 month (visual analog scale varying from 0-10) E. noise (Likert Scale). F. sleep quality (visual analog scale varying from 0-10).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Airsoft Duo First | Experimental | Patients randomized to this arm will be placed on an AIRSOFT DUO mattress for day 0. They will then be switched to a SENTRY 1200 mattress until the end of month 1. Intervention: AIRSOFT DUO for 1 day Intervention: SENTRY 1200 for 1 month |
|
| SENTRY 1200 First | Experimental | Patients randomized to this arm will be placed on a SENTRY 1200 mattress for day 0. They will then be switched to an AIRSOFT DUO mattress until the end of month 1. Intervention: SENTRY 1200 for 1 day Intervention: AIRSOFT DUO for 1 month |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AIRSOFT DUO for 1 day | Device | The patient is placed on an AIRSOFT DUO mattress for 1 day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak interface pressures at the sacral area (mmHg) | Day 0 | |
| Peak interface pressures at the sacral area (mmHg) | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Body contact surface area (cm^2) | Day 0 | |
| Body contact surface area (cm^2) | Day 1 | |
| Peak pressure at the heel area (mmHg) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emilie Viollet, MD | Centre Hospitalier Universitaire de Nīmes | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH de Beziers | Béziers | 34525 | France | |||
| Clinique de Soins de suite et réadaptation Saint Basile |
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| SENTRY 1200 for 1 month | Device | The patient is placed on a SENTRY 1200 mattress for 1 month. |
|
| SENTRY 1200 for 1 day | Device | The patient is placed on a SENTRY 1200 mattress for 1 day. |
|
| AIRSOFT DUO for 1 month | Device | The patient is placed on an AIRSOFT DUO mattress for 1 month. |
|
| Day 0 |
| Peak pressure at the heel area (mmHg) | Day 1 |
| Pressure ulcer development (yes/no) | Month 1 |
| Self-assessment of comfort by the patient (visual analog scale) | Month 1 |
| Self-assessment for noise (Likert scale) | Month 1 |
| Self-assessment of sleep quality (visual analog scale) | Month 1 |
| Mougins |
| 06250 |
| France |
| CHRU de Nîmes - Hôpital Universitaire Carémeau | Nîmes | 30029 | France |
| ID | Term |
|---|---|
| D003668 | Pressure Ulcer |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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