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Completed

NCT Number: NCT02526862

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

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.

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Key information

Conditions

Respiratory Failure Microcephaly, Primary Autosomal Recessive, 6 Pathologic Processes Pathological Conditions, Signs and Symptoms Pressure Ulcer Respiration Disorders Respiratory Aspiration Respiratory Insufficiency Respiratory Tract Diseases Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Emergency and Critical Care. Hospital General Universitario Gregorio Marañón.

Madrid, 28007, Spain

About this study

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®)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Rejects Informed Consent

Treatment and study plan

Allevyn Thin®

Device

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.

Askina Transorbent Border®

Device

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.

Linovera®

Device

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

B. Braun Medical SA

Industry

Collaborators

  • Instituto de Investigación Sanitaria Gregorio Marañón
  • Universidad Rey Juan Carlos

Registry information

Official study title

Prevention of Pressure Ulcers in Patients Under Non-Invasive Mechanical Ventilation. Randomized Clinical Trial

Acronym: PUPPVMNI

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Aug 18, 2015
Registry last updated
Aug 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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