Pressure Ulcer Prevention in Ventilated Patients Using Two Repositioning Regimens

Phase 3

Completed

Conditions: Pressure Ulcers

Interventions: Other: repositioning

Registration Number: NCT00847665

Lead Sponsor: University Hospital Virgen de las Nieves

Brief 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).

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 330

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

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Turning every 2 hours	repositioning	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.
Turning every 4 hours	repositioning	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.

Primary Outcome Measures

Name	Time	Method
Incidence of Pressure Ulcer (PU) Grade ≥ II	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 Outcome Measures

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