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Pressure Ulcer Prevention in Ventilated Patients Using Two Repositioning Regimens (PUPPAS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Francisco Manzano Manzano, University Hospital Virgen de las Nieves
ClinicalTrials.gov Identifier:
NCT00847665
First received: February 18, 2009
Last updated: March 9, 2013
Last verified: March 2013
  Purpose

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).


Condition Intervention Phase
Pressure Ulcers
Other: repositioning
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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.

Resource links provided by NLM:


Further study details as provided by University Hospital Virgen de las Nieves:

Primary Outcome Measures:
  • Incidence of Pressure Ulcer (PU) Grade ≥ II [ Time Frame: Intensive Care Unit (ICU) length of stay (days) ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • ICU Mortality [ Time Frame: ICU length of stay (an average of 28 days) ] [ Designated as safety issue: Yes ]
    ICU mortality (number of death in ICU)

  • Workload of Nurses [ Time Frame: icu length of stay ] [ Designated as safety issue: Yes ]
    Time actually spent to manual repositioning by nurses team, in minutes/day

  • Length of Mechanical Ventilation (MV) [ Time Frame: ICU length of stay ] [ Designated as safety issue: No ]
    Time from initiation to withdrawal of mechanical ventilation. Days


Enrollment: 330
Study Start Date: February 2009
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other: repositioning
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.
Other: repositioning
Turning every 4 or 2 hours

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00847665

Locations
Spain
Hospital Universitario Virgen de las Nieves
Granada, Spain, 18014
Sponsors and Collaborators
University Hospital Virgen de las Nieves
Investigators
Principal Investigator: Francisco Manzano, MD,PhD University Hospital Virgen de las Nieves
  More Information

Additional Information:
Publications:
Responsible Party: Francisco Manzano Manzano, MD,PhD, University Hospital Virgen de las Nieves
ClinicalTrials.gov Identifier: NCT00847665     History of Changes
Other Study ID Numbers: HVN-2308-2008
Study First Received: February 18, 2009
Results First Received: June 28, 2012
Last Updated: March 9, 2013
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by University Hospital Virgen de las Nieves:
Pressure ulcers
Repositioning
Prevention
Mechanical Ventilation
Critical care

Additional relevant MeSH terms:
Pressure Ulcer
Ulcer
Pathologic Processes
Skin Diseases
Skin Ulcer

ClinicalTrials.gov processed this record on November 25, 2014