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

NCT02526862 | Completed Phase 4

• 1 other identifier: PUPPVMNI_200910
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Incidence of PU for each group (mean, standard deviation and quartiles)

  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)

  First 24 hours after the withdrawal of the treatment

Secondary Outcomes (2)

• Incidence of total NIVM related PU, by observation registers.

  24 hours after the withdrawal of the treatment

• 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)

  24 hours after the withdrawal of the treatment

Study Arms (4)

A-Mask or direct interface

NO INTERVENTION

Mask or direct interface

B-Autoadhesive polyurethane dressing

ACTIVE COMPARATOR

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®

C-Semi-permeable hydrogel-foam

ACTIVE COMPARATOR

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®

D-Hyper hydrogenated fatty acids

ACTIVE COMPARATOR

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®

Interventions

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.

B-Autoadhesive polyurethane dressing

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.

C-Semi-permeable hydrogel-foam

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.

D-Hyper hydrogenated fatty acids

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Rejects Informed Consent

Sponsors & Collaborators

• B. Braun Medical SA: lead
• Instituto de Investigación Sanitaria Gregorio Marañón: collaborator
• Universidad Rey Juan Carlos: collaborator

Study Sites (1)

Emergency and Critical Care. Hospital General Universitario Gregorio Marañón.

Madrid, Madrid, 28007, Spain

Location

MeSH Terms

Conditions

Respiratory Insufficiency; Microcephaly, Primary Autosomal Recessive, 6; Respiratory Aspiration; Pressure Ulcer

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• 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)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse, Master of Science

Study Record Dates

• First Submitted: August 6, 2015
• First Posted: August 18, 2015
• Study Start: February 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: August 18, 2015

Record last verified: 2015-08

Locations

ES (1)