Clinical trial NCT00847665: Pressure Ulcer Prevention in Ventilated Patients Using Two Repositioning Regimens
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pressure Ulcers
Keywords: Pressure ulcers
Repositioning
Prevention
Mechanical Ventilation
Critical care
Lead sponsor: University Hospital Virgen de las Nieves
Sponsor class: OTHER
First posted: 2009-02-19
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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).

Detailed description: 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.

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

Primary outcomes:
measure: Incidence of Pressure Ulcer (PU) Grade ≥ II
timeFrame: Intensive Care Unit (ICU) length of stay (days)
Secondary outcomes:
measure: ICU Mortality
timeFrame: ICU length of stay (an average of 28 days)
measure: Workload of Nurses
timeFrame: icu length of stay
measure: Length of Mechanical Ventilation (MV)
timeFrame: ICU length of stay
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves
Study officials:
affiliation: University Hospital Virgen de las Nieves
name: Francisco Manzano, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vanderwee K, Grypdonck MH, De Bacquer D, Defloor T. Effectiveness of turning with unequal time intervals on the incidence of pressure ulcer lesions. J Adv Nurs. 2007 Jan;57(1):59-68. doi: 10.1111/j.1365-2648.2006.04060.x.
citation: Defloor T, De Bacquer D, Grypdonck MH. The effect of various combinations of turning and pressure reducing devices on the incidence of pressure ulcers. Int J Nurs Stud. 2005 Jan;42(1):37-46. doi: 10.1016/j.ijnurstu.2004.05.013.
citation: Krapfl LA, Gray M. Does regular repositioning prevent pressure ulcers? J Wound Ostomy Continence Nurs. 2008 Nov-Dec;35(6):571-7. doi: 10.1097/01.WON.0000341469.33567.61.