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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

152 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2013-08-31

Brief Summary

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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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Detailed Description

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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®)

Conditions

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Respiratory Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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A-Mask or direct interface

Mask or direct interface

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type ACTIVE_COMPARATOR

Allevyn Thin®

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Askina Transorbent Border®

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Linovera®

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Rejects Informed Consent

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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David Peña Otero

Nurse, Master of Science

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David Peña-Otero, M.Sc.

Role: PRINCIPAL_INVESTIGATOR

Nurse. Emergency and Critical Care. Hospital General Universitario Gregorio Marañón. Nursing Faculty. Universidad Rey Juan Carlos. Instituto de Investigación Sanitaria Gregorio Marañón (IiSGM)