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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Turning every 4 hours | Active Comparator | 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. |
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| Turning every 2 hours | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| repositioning | Other | Turning every 4 or 2 hours |
|
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francisco Manzano, MD,PhD | University Hospital Virgen de las Nieves | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Virgen de las Nieves | Granada | Granada | 18014 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17184374 | Background | 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. | |
| 15582638 | Background | 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. |
| Label | URL |
|---|---|
| University Hospital Virgen de las Nieves | View source |
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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,...)
A medical-surgical ICU of a university hospital. Patients were recruited from february 2009 to January 2011
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Turning Every 2 Hours |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Intention to treat | Posted | Number | participants | Intensive Care Unit (ICU) length of stay (days) |
|
2 year
ICU length of stay for each patient
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| unplanned extubation | Respiratory, thoracic and mediastinal disorders | Other | Systematic Assessment | Unplanned extubation is defined as premature removal of the endotracheal tube by action of the patient or during care and manipulation of the patient |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Endotracheal tube obstruction | Respiratory, thoracic and mediastinal disorders | Other | Systematic Assessment | Defined when clinically suspected and diagnosed by the attended physician, because of the presence of visible airway secretion into the endotracheal tube. There was always the need to use isotonic saline instillation before tracheal suctioning. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Francisco Manzano | University Hospital Virgen de las Nieves | 34958020125 | fmanzano@mailpersonal.com |
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| ID | Term |
|---|---|
| D003668 | Pressure Ulcer |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| icu length of stay |
| Length of Mechanical Ventilation (MV) | Time from initiation to withdrawal of mechanical ventilation. Days | ICU length of stay |
| 19018196 | Background | 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. |
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
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | ICU Mortality | ICU mortality (number of death in ICU) | Posted | Number | participants | ICU length of stay (an average of 28 days) |
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| Secondary | Workload of Nurses | Time actually spent to manual repositioning by nurses team, in minutes/day | Posted | Median | Inter-Quartile Range | minutes per day | icu length of stay |
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| Secondary | Length of Mechanical Ventilation (MV) | Time from initiation to withdrawal of mechanical ventilation. Days | Posted | Median | Inter-Quartile Range | days | ICU length of stay |
|
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|
| 15 |
| 164 |
| 50 |
| 164 |
| EG001 | 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 | 23 | 165 | 60 | 165 |
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| Loss of medical devices | Surgical and medical procedures | Other | Systematic Assessment |
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