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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Francisco Manzano Manzano, University Hospital Virgen de las Nieves
ClinicalTrials.gov Identifier:
NCT00847665
First received: February 18, 2009
Last updated: March 9, 2013
Last verified: March 2013
Results First Received: June 28, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Pressure Ulcers
Intervention: Other: repositioning

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A medical-surgical ICU of a university hospital. Patients were recruited from february 2009 to January 2011

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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,...)

Reporting Groups
  Description
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
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

Participant Flow:   Overall Study
    Turning Every 4 Hours     Turning Every 2 Hours  
STARTED     165     165  
COMPLETED     164     165  
NOT COMPLETED     1     0  
Withdrawal by Subject                 1                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
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
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
Total Total of all reporting groups

Baseline Measures
    Turning Every 4 Hours     Turning Every 2 Hours     Total  
Number of Participants  
[units: participants]
  165     165     330  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     89     81     170  
>=65 years     76     84     160  
Age  
[units: years]
Mean ± Standard Deviation
  61  ± 15     62  ± 14     61  ± 15  
Gender  
[units: participants]
     
Female     54     56     110  
Male     111     109     220  
Region of Enrollment  
[units: participants]
     
Spain     165     165     330  



  Outcome Measures
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1.  Primary:   Incidence of Pressure Ulcer (PU) Grade ≥ II   [ Time Frame: Intensive Care Unit (ICU) length of stay (days) ]

2.  Secondary:   ICU Mortality   [ Time Frame: ICU length of stay (an average of 28 days) ]

3.  Secondary:   Workload of Nurses   [ Time Frame: icu length of stay ]

4.  Secondary:   Length of Mechanical Ventilation (MV)   [ Time Frame: ICU length of stay ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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
e-mail: fmanzano@mailpersonal.com


Publications:

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
Study First Received: February 18, 2009
Results First Received: June 28, 2012
Last Updated: March 9, 2013
Health Authority: Spain: Comité Ético de Investigación Clínica