Pressure Ulcers
Conditions
Keywords
Pressure ulcers, Repositioning, Prevention, Mechanical Ventilation, Critical care
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.
Interventions
OTHERrepositioning
Turning every 4 or 2 hours
Sponsors
University Hospital Virgen de las Nieves
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Spain
Participant flow
Recruitment details
A medical-surgical ICU of a university hospital. Patients were recruited from february 2009 to January 2011
Pre-assignment details
A total of 512 patients with more than 24 hours of mechanical ventilation were screened. 55 patients were excluded because of the presence of pressure ulcer. Other 126 patients were excluded because of the presence of other exclusion criteria (age, pregnancy, refusal of consent,...)
Participants by arm
| Arm | Count |
|---|---|
| Turning Every 4 Hours Repositioning by the nursing staff every four hours (left side, back with a 30º elevation of the head end and the foot end of the bed, right side, back), using the 30º tilt | 165 |
| Turning Every 2 Hours Repositioning by the nursing staff every two hours (left side, back with a 30º elevation of the head end and the foot end of the bed, right side, back), using the 30º tilt | 165 |
| Total | 330 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Turning Every 2 Hours | Turning Every 4 Hours | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 84 Participants | 76 Participants | 160 Participants |
| Age, Categorical Between 18 and 65 years | 81 Participants | 89 Participants | 170 Participants |
| Age Continuous | 62 years STANDARD_DEVIATION 14 | 61 years STANDARD_DEVIATION 15 | 61 years STANDARD_DEVIATION 15 |
| Region of Enrollment Spain | 165 participants | 165 participants | 330 participants |
| Sex: Female, Male Female | 56 Participants | 54 Participants | 110 Participants |
| Sex: Female, Male Male | 109 Participants | 111 Participants | 220 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 50 / 164 | 60 / 165 |
| serious Total, serious adverse events | 15 / 164 | 23 / 165 |
Outcome results
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
Time frame: Intensive Care Unit (ICU) length of stay (days)
Population: Intention to treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Turning Every 4 Hours | Incidence of Pressure Ulcer (PU) Grade ≥ II | 22 participants |
| Turning Every 2 Hours | Incidence of Pressure Ulcer (PU) Grade ≥ II | 17 participants |
Secondary
ICU Mortality
ICU mortality (number of death in ICU)
Time frame: ICU length of stay (an average of 28 days)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Turning Every 4 Hours | ICU Mortality | 51 participants |
| Turning Every 2 Hours | ICU Mortality | 60 participants |
Secondary
Length of Mechanical Ventilation (MV)
Time from initiation to withdrawal of mechanical ventilation. Days
Time frame: ICU length of stay
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Turning Every 4 Hours | Length of Mechanical Ventilation (MV) | 8 days |
| Turning Every 2 Hours | Length of Mechanical Ventilation (MV) | 7 days |
Secondary
Workload of Nurses
Time actually spent to manual repositioning by nurses team, in minutes/day
Time frame: icu length of stay
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Turning Every 4 Hours | Workload of Nurses | 10.6 minutes per day |
| Turning Every 2 Hours | Workload of Nurses | 20.8 minutes per day |