Pressure Ulcer Prevention in Ventilated Patients Using Two Repositioning Regimens

Pressure Ulcers Clinical Trial

— PUPPAS  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00847665
• Other study ID #: HVN-2308-2008
• Status: Completed
• Phase: Phase 3
• First received: February 18, 2009
• Last updated: March 9, 2013
• Start date: February 2009
• Est. completion date: May 2011

Study information

• Verified date: March 2013
• Source: University Hospital Virgen de las Nieves
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 330
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pressure Ulcer
• Pressure Ulcers
• Ulcer

Intervention

Other:
• repositioning
Turning every 4 or 2 hours

Locations

Country	Name	City	State
Spain	Hospital Universitario Virgen de las Nieves	Granada

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Virgen de las Nieves

Country where clinical trial is conducted

Spain, 

References & Publications (3)

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. — View 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. Review. Erratum in: J Wound Ostomy Continence Nurs. 2009 Jan-Feb;36(1):34. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes
Secondary	ICU Mortality	ICU mortality (number of death in ICU)	ICU length of stay (an average of 28 days)	Yes
Secondary	Workload of Nurses	Time actually spent to manual repositioning by nurses team, in minutes/day	icu length of stay	Yes
Secondary	Length of Mechanical Ventilation (MV)	Time from initiation to withdrawal of mechanical ventilation. Days	ICU length of stay	No

External Links

•   University Hospital Virgen de las Nieves