Phase 3
N=330
Pressure Ulcer Prevention in Ventilated Patients Using Two Repositioning Regimens
Pressure Ulcers
Bottom Line
View on ClinicalTrials.gov: NCT00847665 ↗Enrolled (actual)
330
Serious AEs
11.6%
Results posted
Apr 2013
Primary outcome: Primary: Incidence of Pressure Ulcer (PU) Grade ≥ II — 22; 17 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- repositioning (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University Hospital Virgen de las Nieves
- Primary completion
- May 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Pressure Ulcer (PU) Grade ≥ II |
22; 17 | — |
| SECONDARY ICU Mortality |
51; 60 | — |
| SECONDARY Workload of Nurses |
10.6; 20.8 | — |
| SECONDARY Length of Mechanical Ventilation (MV) |
8; 7 | — |
Summary
The purpose of this study is to compare a 2-hour versus every 4-hour turning regimen on the incidence of grade > II pressure ulcers (PU) in patients in ICU on mechanical ventilation ≥ 24h that use alternating-pressure air mattresses (APAMs).
Eligibility Criteria
Inclusion Criteria
- Patients admitted to the medical-surgical ICU, requiring more than 24 hours of mechanical ventilation.
- Patients on alternating-pressure air mattresses.
- Patients or their legal representative able to provide written informed consent to participate in the study
- Patients whose weight are within the limits accepted by the mattresses (45-140 Kg)
- Over 18 years
Exclusion Criteria
- Patients with pressure ulcer at ICU admission.
- Pregnant patients
- Patients in which informed consent is not obtained in the first 48 hours of mechanical ventilation
Data sourced from ClinicalTrials.gov (NCT00847665). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.