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

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ClinicalTrials.gov Identifier: NCT00847665
Recruitment Status : Completed
First Posted : February 19, 2009
Results First Posted : April 17, 2013
Last Update Posted : April 17, 2013
Sponsor:
Information provided by (Responsible Party):
Francisco Manzano Manzano, University Hospital Virgen de las Nieves

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Pressure Ulcers
Intervention Other: repositioning
Enrollment 330

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,...)
Arm/Group Title Turning Every 4 Hours Turning Every 2 Hours
Hide Arm/Group Description 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 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
Period Title: Overall Study
Started 165 165
Completed 164 165
Not Completed 1 0
Reason Not Completed
Withdrawal by Subject             1             0
Arm/Group Title Turning Every 4 Hours Turning Every 2 Hours Total
Hide Arm/Group Description 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 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 Total of all reporting groups
Overall Number of Baseline Participants 165 165 330
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 165 participants 165 participants 330 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
89
  53.9%
81
  49.1%
170
  51.5%
>=65 years
76
  46.1%
84
  50.9%
160
  48.5%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 165 participants 165 participants 330 participants
61  (15) 62  (14) 61  (15)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 165 participants 165 participants 330 participants
Female
54
  32.7%
56
  33.9%
110
  33.3%
Male
111
  67.3%
109
  66.1%
220
  66.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Spain Number Analyzed 165 participants 165 participants 330 participants
165 165 330
1.Primary Outcome
Title Incidence of Pressure Ulcer (PU) Grade ≥ II
Hide Description 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to treat
Arm/Group Title Turning Every 4 Hours Turning Every 2 Hours
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 164 165
Measure Type: Number
Unit of Measure: participants
22 17
2.Secondary Outcome
Title ICU Mortality
Hide Description ICU mortality (number of death in ICU)
Time Frame ICU length of stay (an average of 28 days)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Turning Every 4 Hours Turning Every 2 Hours
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 164 165
Measure Type: Number
Unit of Measure: participants
51 60
3.Secondary Outcome
Title Workload of Nurses
Hide Description Time actually spent to manual repositioning by nurses team, in minutes/day
Time Frame icu length of stay
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Turning Every 4 Hours Turning Every 2 Hours
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 164 165
Median (Inter-Quartile Range)
Unit of Measure: minutes per day
10.6
(7.9 to 14.9)
20.8
(14.4 to 27.4)
4.Secondary Outcome
Title Length of Mechanical Ventilation (MV)
Hide Description Time from initiation to withdrawal of mechanical ventilation. Days
Time Frame ICU length of stay
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Turning Every 4 Hours Turning Every 2 Hours
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 164 165
Median (Inter-Quartile Range)
Unit of Measure: days
8
(5 to 15)
7
(3 to 15)
Time Frame 2 year
Adverse Event Reporting Description ICU length of stay for each patient
 
Arm/Group Title Turning Every 4 Hours Turning Every 2 Hours
Hide Arm/Group Description 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 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
All-Cause Mortality
Turning Every 4 Hours Turning Every 2 Hours
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Turning Every 4 Hours Turning Every 2 Hours
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   15/164 (9.15%)      23/165 (13.94%)    
Respiratory, thoracic and mediastinal disorders     
unplanned extubation  1 [1]  11/164 (6.71%)  11 19/165 (11.52%)  19
Surgical and medical procedures     
Loss of medical devices  1  12/164 (7.32%)  12 15/165 (9.09%)  15
Indicates events were collected by systematic assessment
1
Term from vocabulary, Other
[1]
Unplanned extubation is defined as premature removal of the endotracheal tube by action of the patient or during care and manipulation of the patient
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Turning Every 4 Hours Turning Every 2 Hours
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   50/164 (30.49%)      60/165 (36.36%)    
Respiratory, thoracic and mediastinal disorders     
Endotracheal tube obstruction  1 [1]  50/164 (30.49%)  50 60/165 (36.36%)  60
Indicates events were collected by systematic assessment
1
Term from vocabulary, Other
[1]
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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Francisco Manzano
Organization: University Hospital Virgen de las Nieves
Phone: 34958020125
Responsible Party: Francisco Manzano Manzano, University Hospital Virgen de las Nieves
ClinicalTrials.gov Identifier: NCT00847665     History of Changes
Other Study ID Numbers: HVN-2308-2008
First Submitted: February 18, 2009
First Posted: February 19, 2009
Results First Submitted: June 28, 2012
Results First Posted: April 17, 2013
Last Update Posted: April 17, 2013