Clinical trial NCT02526862: Prevention of Pressure Ulcers in Patients Under Non-Invasive Mechanical Ventilation
Official title: Prevention of Pressure Ulcers in Patients Under Non-Invasive Mechanical Ventilation. Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Respiratory Failure
Keywords: noninvasive mechanical ventilation (NIVM)
continuous positive airway pressure (CPAP) ventilation
bilevel positive airway pressure (BIPAP) ventilation
pressure ulcer (PU)
nursing assessment
Lead sponsor: B. Braun Medical SA
Sponsor class: INDUSTRY
Collaborators: name: Instituto de Investigación Sanitaria Gregorio Marañón
name: Universidad Rey Juan Carlos
First posted: 2015-08-18
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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®)

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Rejects Informed Consent

Primary outcomes:
measure: Incidence of PU for each group (mean, standard deviation and quartiles)
timeFrame: First 24 hours after the withdrawal of the treatment
Secondary outcomes:
measure: Incidence of total NIVM related PU, by observation registers.
timeFrame: 24 hours after the withdrawal of the treatment
measure: 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)
timeFrame: 24 hours after the withdrawal of the treatment
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Emergency and Critical Care. Hospital General Universitario Gregorio Marañón.
Study officials:
affiliation: Nurse. Emergency and Critical Care. Hospital General Universitario Gregorio Marañón. Nursing Faculty. Universidad Rey Juan Carlos. Instituto de Investigación Sanitaria Gregorio Marañón (IiSGM)
name: David Peña-Otero, M.Sc.
role: PRINCIPAL_INVESTIGATOR
References: