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

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.

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).

Study Overview

• Status: Completed
• Conditions: Pressure Ulcers
• Intervention / Treatment: Other: repositioning

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.

• Study Type: Interventional
• Enrollment (Actual): 330
• Phase: Phase 3

Contacts and Locations

Study Locations

• Spain
  • Granada, Spain, 18014
    • Hospital Universitario Virgen de Las Nieves

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Pressure Ulcer (PU) Grade ≥ II	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	Intensive Care Unit (ICU) length of stay (days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ICU Mortality	ICU mortality (number of death in ICU)	ICU length of stay (an average of 28 days)
Workload of Nurses	Time actually spent to manual repositioning by nurses team, in minutes/day	icu length of stay
Length of Mechanical Ventilation (MV)	Time from initiation to withdrawal of mechanical ventilation. Days	ICU length of stay

Collaborators and Investigators

• Sponsor: University Hospital Virgen de las Nieves
• Investigators: Principal Investigator: Francisco Manzano, MD,PhD, University Hospital Virgen de las Nieves

Publications and helpful links

General Publications

• 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.
• 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.
• 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. Erratum In: J Wound Ostomy Continence Nurs. 2009 Jan-Feb;36(1):34.

Helpful Links

• University Hospital Virgen de las Nieves

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: February 18, 2009
• First Submitted That Met QC Criteria: February 18, 2009
• First Posted (Estimate): February 19, 2009

Study Record Updates

• Last Update Posted (Estimate): April 17, 2013
• Last Update Submitted That Met QC Criteria: March 9, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Keywords: Prevention; Critical care; Mechanical Ventilation; Pressure ulcers; Repositioning
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Skin Ulcer; Ulcer; Pressure Ulcer
• Other Study ID Numbers: HVN-2308-2008