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

B. Braun

Status and phase: Completed; Phase 4

Conditions: Respiratory Failure

Treatments: Device: Allevyn Thin®; Device: Linovera®; Device: Askina Transorbent Border®

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02526862

PUPPVMNI_200910

Details and patient eligibility

About

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.

Full 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®)

Enrollment: 152 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Rejects Informed Consent

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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152 participants in 4 patient groups

A-Mask or direct interface

No Intervention group

Description:

Mask or direct interface

B-Autoadhesive polyurethane dressing

Active Comparator group

Description:

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.

Treatment:

Device: Allevyn Thin®

C-Semi-permeable hydrogel-foam

Active Comparator group

Description:

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.

Treatment:

Device: Askina Transorbent Border®

D-Hyper hydrogenated fatty acids

Active Comparator group

Description:

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.

Treatment:

Device: Linovera®