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Prevention of Pressure Ulcers in Patients Under Non-Invasive Mechanical Ventilation (PUPPVMNI)

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ClinicalTrials.gov Identifier: NCT02526862
Recruitment Status : Completed
First Posted : August 18, 2015
Last Update Posted : August 18, 2015
Sponsor:
Collaborators:
Instituto de Investigación Sanitaria Gregorio Marañón
Universidad Rey Juan Carlos
Information provided by (Responsible Party):
David Peña Otero, Hospital General Universitario Gregorio Marañon

Brief Summary:
This study aims to test direct application of the Non-Invasive Mechanical Ventilation -NIVM- mask or interface as the most efficient intervention to prevent Pressure Ulcers (PU), compared with other three usual preventive measures which consist in the use of three different medical devices.

Condition or disease Intervention/treatment Phase
Respiratory Failure Device: Allevyn Thin® Device: Askina Transorbent Border® Device: Linovera® Phase 4

Detailed Description:

Non-Invasive Mechanical Ventilation (NIVM) has turned into a standard in the care of patients with acute respiratory failure. Defined as a support modality to the patient`s spontaneous ventilation, it does not use invasive techniques to ventilate, working as an external device named interface or mask, avoiding so the complications associated to the invasive ventilation.

NIVM had been restricted to ICU and Pneumology services, but in the last years it has been extended to ER with good results and it is being also used in the pre-hospital attention and in the home care of chronic patient.

Often, the preferred interface is the oronasal, worst tolerated but associated to best treatment of the acute pathology. In most cases to avoid air leaks, its proper placement generates high pressure on the skin, being able to harm patient`s tissues, so that this therapy as intervention for the acute patient has pressure ulcers -PU- as main iatrogenic effect - although 95% of the PU are considered as preventable-.

To diminish the pressure of the mask on the points of the face, nurses protect the most exposed zones with dressings of hydrogel-foam, polyurethane and/or hyperoxygenated fatty acids, trying to prevent PU.

Reviewed studies present a big variability in these practices as well as high dispersion of the results achieved.

Preventive measures are different and even none, as applying the mask or the interface directly could be the most effective treatment in the prevention of PU, avoiding not justified increase of fungible and other resources consumption.

The aim of this study is to test direct application of the mask or interface, as the most efficient intervention, compared with other three usual preventive measures which consist in the use of three different medical devices: autoadhesive polyurethane dressing (Allevyn Thin®), semi-permeable hydrogel-foams adhesive dressing (Askina Transorbent Border®) or hyperoxygenated fatty acids (Linovera®)


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 152 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prevention of Pressure Ulcers in Patients Under Non-Invasive Mechanical Ventilation. Randomized Clinical Trial
Study Start Date : February 2012
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pressure Sores

Arm Intervention/treatment
No Intervention: A-Mask or direct interface
Mask or direct interface
Active Comparator: B-Autoadhesive polyurethane dressing
Protection of the dermis with autoadhesive polyurethane dressing (Allevyn Thin®). The dressing will be standardized cut to avoid bias. The edges shape will be circular. They will be set in nasal bridge and cheekbones, avoiding frontal level. It will be checked every six hours, and if not properly fixed it will be applied again in the same way.
Device: Allevyn Thin®
Protection of the dermis with autoadhesive polyurethane dressing. The dressing will be standardized cut to avoid bias. The edges shape will be circular. They will be set in nasal bridge and cheekbones, avoiding frontal level. It will be checked every six hours, and if not properly fixed it will be applied again in the same way.

Active Comparator: C-Semi-permeable hydrogel-foam
Protection of the dermis with semi-permeable hydrogel-foams adhesive dressing (Askina Transorbent Border®). The dressing will be standardized cut to avoid bias. The edges shape will be circular. They will be set in nasal bridge and cheekbones, avoiding frontal level. It will be checked every six hours, and if not properly fixed it will be applied again in the same way.
Device: Askina Transorbent Border®
Protection of the dermis with semi-permeable hydrogel-foams adhesive dressing. The dressing will be standardized cut to avoid bias. The edges shape will be circular. They will be set in nasal bridge and cheekbones, avoiding frontal level. It will be checked every six hours, and if not properly fixed it will be applied again in the same way.

Active Comparator: D-Hyper hydrogenated fatty acids
Protection of the dermis with hyper hydrogenated fatty acids (Linovera®) in the contact areas with the NIVM interface or mask. It will apply with its doser and gently massaged in chin, cheekbones, nasal and frontal bridge as indicated in the product. It will be checked every six hours for proper hydration and if needed it will be applied again in the same way.
Device: Linovera®
Protection of the dermis with hyper hydrogenated fatty acids. It will be applied with its doser and gently massaged in chin, cheekbones, nasal and frontal bridge as indicated in the product. It will be checked every six hours for proper hydration and if needed it will be applied again in the same way.




Primary Outcome Measures :
  1. Incidence of PU for each group (mean, standard deviation and quartiles) [ Time Frame: First 24 hours after the withdrawal of the treatment ]

    Compare the efficacy of the preventive treatments A, B, C and D - previously described-(meaning by efficacy the no occurrence of PU).

    For definition of PU investigators use the one of the "National Group for the Study and Advice in Pressure Ulcer and Chronic Wounds" (GNEAUPP)



Secondary Outcome Measures :
  1. Incidence of total NIVM related PU, by observation registers. [ Time Frame: 24 hours after the withdrawal of the treatment ]
    Total incidence of NIVM related PU within the first 24 hours after the withdrawal of the treatment, registered for the different preventive procedures.

  2. Efficiency of preventive measures for PU related to NIVM, by registering incidence and resources invested -time in hours and consumables in euros- (mean, standard deviation and quartiles for each group) [ Time Frame: 24 hours after the withdrawal of the treatment ]
    Compare the efficacy and efficiency (cost related efficacy) of the preventive treatments A, B, C and D - previously described



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults (≥18 years).
  • Not tissue injury in face.
  • Not structural deformation of the facial anatomy.

Exclusion Criteria:

  • Rejects Informed Consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02526862


Locations
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Spain
Emergency and Critical Care. Hospital General Universitario Gregorio Marañón.
Madrid, Spain, 28007
Sponsors and Collaborators
B. Braun Medical SA
Instituto de Investigación Sanitaria Gregorio Marañón
Universidad Rey Juan Carlos
Investigators
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Principal Investigator: David Peña-Otero, M.Sc. Nurse. Emergency and Critical Care. Hospital General Universitario Gregorio Marañón. Nursing Faculty. Universidad Rey Juan Carlos. Instituto de Investigación Sanitaria Gregorio Marañón (IiSGM)

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Responsible Party: David Peña Otero, Nurse, Master of Science, Hospital General Universitario Gregorio Marañon
ClinicalTrials.gov Identifier: NCT02526862     History of Changes
Other Study ID Numbers: PUPPVMNI_200910
First Posted: August 18, 2015    Key Record Dates
Last Update Posted: August 18, 2015
Last Verified: August 2015
Keywords provided by David Peña Otero, Hospital General Universitario Gregorio Marañon:
noninvasive mechanical ventilation (NIVM)
continuous positive airway pressure (CPAP) ventilation
bilevel positive airway pressure (BIPAP) ventilation
pressure ulcer (PU)
nursing assessment
Additional relevant MeSH terms:
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Respiratory Insufficiency
Pressure Ulcer
Respiration Disorders
Respiratory Tract Diseases
Skin Ulcer
Skin Diseases