Phase 3 Completed N=330 Randomized Prevention

Pressure Ulcer Prevention in Ventilated Patients Using Two Repositioning Regimens

Pressure Ulcer

Source: ClinicalTrials.gov NCT00847665 ↗

Enrolled (actual)

330

Serious AEs

11.6%

Results posted

Apr 2013

Primary outcomePrimary: Incidence of Pressure Ulcer (PU) Grade ≥ II — 22; 17 participants

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).

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	—

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

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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. Informational only — not medical advice.