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Pressure Ulcer Prevention in Ventilated Patients Using Two Repositioning Regimens (PUPPAS)
This study is currently recruiting participants.
Verified by University Hospital Virgen de las Nieves, February 2009
First Received: February 18, 2009   No Changes Posted
Sponsored by: University Hospital Virgen de las Nieves
Information provided by: University Hospital Virgen de las Nieves
ClinicalTrials.gov Identifier: NCT00847665
  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 III

MedlinePlus related topics: Pressure Sores
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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.

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

Primary Outcome Measures:
  • Incidence of PU grade ≥ II [ Time Frame: ICU length of stay ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Incidence of major and minor events Time to development of PU grade ≥ II Percentage of implementation by caregivers of scheduled turning Time consumed in repositioning Length of mechanical ventilation Length of ICU stay ICU mortality [ Time Frame: ICU length of stay ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 330
Study Start Date: February 2009
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Turning every 4 hours: Active Comparator Other: repositioning
Turning every 4 or 2 hours
Turning every 2 hours: Experimental 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 ≥ 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00847665

Contacts
Contact: Francisco Manzano, PhD, MD +34958020125 fmanzano@mailpersonal.com

Locations
Spain
Hospital Universitario Virgen de las Nieves Recruiting
Granada, Spain, 18014
Contact: Francisco Manzano, PhD, MD     +34958020125     fmanzano@mailpersonal.com    
Contact: Manuel Colmenero, PhD, MD     +34958020125     macol@telefonica.net    
Principal Investigator: Francisco Manzano, PhD, MD            
Sponsors and Collaborators
University Hospital Virgen de las Nieves
  More Information

Additional Information:
Publications:
Responsible Party: University Hospital Virgen de las Nieves. Servicio Andaluz de Salud ( Francisco Manzano, PhD, MD )
Study ID Numbers: HVN-2308-2008
Study First Received: February 18, 2009
Last Updated: February 18, 2009
ClinicalTrials.gov Identifier: NCT00847665     History of Changes
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

Study placed in the following topic categories:
Skin Diseases
Ulcer
Skin Ulcer
Pressure Ulcer

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

ClinicalTrials.gov processed this record on May 07, 2009