At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 330 enrolled
Drug / intervention
repositioningother
Likely dose
Not stated in record
Key inclusion· 5
- ✓Admitted to medical-surgical ICU requiring >24 hours of mechanical ventilation
- ✓On alternating-pressure air mattresses
- ✓Weight 45–140 kg (within mattress limits)
- ✓Age ≥18 years
Key exclusion· 3
- ✕Pressure ulcer present at ICU admission
- ✕Pregnant
- ✕Informed consent not obtained within first 48 hours of mechanical ventilation
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Comparison of Two Turning Regimens (2 Versus Every 4 Hours) in the Prevention of Pressure Ulcers in Patients on Mechanical Ventilation That Use Alternating-pressure Air Mattresses.
In Brief
A Phase 3 clinical trial evaluating repositioning for Pressure Ulcers. Completed, enrolled 330 participants across 1 site.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPressure Ulcers
CountriesSpain
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartFeb 2009
First PostedFeb 2009
Primary CompletionMay 2011
TodayJul 2026
First PostedFeb 19, 2009
Enrollment StartFeb 1, 2009
Primary CompletionMay 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 17.4 years ago
Interventions
repositioningother
Turning every 4 or 2 hours