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Completed

NCT Number: NCT00847665

Pressure Ulcer Prevention in Ventilated Patients Using Two Repositioning Regimens

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Universitario Virgen de las Nieves

Granada, 18014, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

repositioning

Other

Turning every 4 or 2 hours

Primary outcomes

  1. 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

Secondary outcomes

  1. ICU Mortality

    Time frame: ICU length of stay (an average of 28 days)

    ICU mortality (number of death in ICU)

  2. Workload of Nurses

    Time frame: icu length of stay

    Time actually spent to manual repositioning by nurses team, in minutes/day

  3. Length of Mechanical Ventilation (MV)

    Time frame: ICU length of stay

    Time from initiation to withdrawal of mechanical ventilation. Days

Sponsors and collaborators

Lead sponsor

University Hospital Virgen de las Nieves

Other

Registry information

Official study 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.

Acronym: PUPPAS

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Feb 19, 2009
Registry last updated
Apr 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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