Pressure Ulcer Prevention in Ventilated Patients Using Two Repositioning Regimens (PUPPAS)
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|ClinicalTrials.gov Identifier: NCT00847665|
Recruitment Status : Completed
First Posted : February 19, 2009
Results First Posted : April 17, 2013
Last Update Posted : April 17, 2013
|Condition or disease||Intervention/treatment||Phase|
|Pressure Ulcers||Other: repositioning||Phase 3|
Pressure ulcers (PUs) pose a major healthcare challenge and are associated with an increased risk of infection and sepsis, longer hospital stay, and higher hospitalization costs. Their reported incidence in critical care patients varies widely from 1% to 56%. Therefore it is important to take appropriate preventive measures, which can often be successful and less costly than the treatment of established ulcers. Among these measures are the use of pressure-reducing surfaces and repositioning strategies in a protocolized way. Though there is general agreement that critical care patients, including those under mechanical ventilation must use pressure-reducing surfaces, there is no enough evidence in the literature about what is the best repositioning schedule when new, high technology mattresses are used. The use of this new technology has lead to propose that repositioning can be less frequent. In the only clinical trial where this subject (time interval turning) has been addressed (Vanderwee et al, Journal of Advanced Nursing), it is concluded that a turning regimen every 4 hours is equally effective than a 2-hour turning, using this kind of mattresses. Nonetheless this study is not made in critically ill patients, that have more risk factors for developing PUs, the reason we don´t share this findings and recommendations cannot be generalized.
The study hypothesis is that in patients using APAMs, a turning regimen every 2 hour compared to a 4-hour is most effective in the prevention of PUs and could be equally safe.
The objective of this study is to investigate the effect of postural turnings every 2 hours compared to every 4 hours on the incidence of grade > II pressure ulcers (PU) in patients in ICU on mechanical ventilation (MV) ≥ 24h that use alternating-pressure air mattresses (APAMs) The study is an open label, randomized, controlled clinical trial. The main variable is the incidence of Pus grade ≥ II. As secondary variables measures of efficacy and safety of patients will be registered. The study will take place in a 26 bed medical-surgical ICU with APAMs. Randomization will be done between 24h-48h from the beginning of MV. The final analysis will be by intention to treat.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||330 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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.|
|Study Start Date :||February 2009|
|Primary Completion Date :||May 2011|
|Study Completion Date :||May 2011|
Active Comparator: Turning every 4 hours
The four-hours repositioning group patients were turned every four hours following the next sequence: left side, back with a 30º elevation of the head end and the foot end of the bed, right side using the 30º tilt, back.
Turning every 4 or 2 hours
Experimental: Turning every 2 hours
The two-hours repositioning group patients, were turned every two hours following the next sequence: left side, back with a 30º elevation of the head end and the foot end of the bed, right side using the 30º tilt, back.
Turning every 4 or 2 hours
- Incidence of Pressure Ulcer (PU) Grade ≥ II [ Time Frame: Intensive Care Unit (ICU) length of stay (days) ]Pressure ulcers were categorized according to the EPUAP-classification system. A grade I PU is non-blanchable erythema, a grade II is an abrasion or blister, a grade III is a superficial ulcer and a grade IV is a deep ulcer
- ICU Mortality [ Time Frame: ICU length of stay (an average of 28 days) ]ICU mortality (number of death in ICU)
- Workload of Nurses [ Time Frame: icu length of stay ]Time actually spent to manual repositioning by nurses team, in minutes/day
- Length of Mechanical Ventilation (MV) [ Time Frame: ICU length of stay ]Time from initiation to withdrawal of mechanical ventilation. Days
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00847665
|Hospital Universitario Virgen de las Nieves|
|Granada, Spain, 18014|
|Principal Investigator:||Francisco Manzano, MD,PhD||University Hospital Virgen de las Nieves|