Prevention of Damage Induced by Facial Mask Ventilation
3PROSNIV
Comparison of Three Devices to Prevent Skin Damage Induced by Facial Mask Ventilation During Acute Respiratory Failure: a Multicenter Randomised Controlled Study
1 other identifier
interventional
252
1 country
1
Brief Summary
In patients with acute respiratory failure (ARF) undergoing noninvasive ventilation (NIV), the main complication of the use of the mask is the development of decubitus, sometimes so severe and painful as to force a suspension of the NIV itself . The lesions are mainly located at the nasal bridge, as at this level the skin thin and placed directly on the bone is particularly vulnerable to the injury as consequence of the friction and pressure induced by the movement of the mask. The strategy of prevention and treatment commonly adopted is the application of hydrocolloids. However, precise data are lacking about the demonstration of the effectiveness of these devices and the possibility of using other protective devices. The purpose of this study was to evaluate the usefulness of large-scale three different systems of protection vs. no protection in preventing the development of decubitus lesions in patients receiving NIV for an episode of ARF.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 5, 2011
CompletedFirst Posted
Study publicly available on registry
May 10, 2011
CompletedStudy Start
First participant enrolled
December 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedDecember 31, 2014
December 1, 2014
3.4 years
May 5, 2011
December 29, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Failure rate of the prevention of the facial mask ventilation-induced skin damage in the three interventional groups and in the control group
7 days
Secondary Outcomes (4)
Mask-induced discomfort
7 days
Costs for skin protection
7 days
Prediction of NIV-induced skin damage
7 days
Success of NIV
Up to 30 days
Study Arms (4)
polyurethane foam (Allewyn adesive)
ACTIVE COMPARATORPolyurethane foam is applied as skin protective dressing device before NIV and kept on site till the 7th day of treatment Intervention: active prophilactic barrier against skin breakdown
polyurethane film (Tegaderm)
ACTIVE COMPARATORThe polyurethane film is applied ss skin protective dressing device before NIV and kept on site till the 7th day of treatment Intervention: active prophilactic barrier against skin breakdown
Hydrocolloid (Duoderm)
ACTIVE COMPARATORHydrocolloid is applied ss skin protective dressing device before NIV and kept on site till the 7th day of treatment Intervention: active prophilactic barrier against skin breakdown
Control
NO INTERVENTIONIn this no-intervention arm, any skin protective dressing devices is applied before NIV starting
Interventions
Application of one the three indicated devices (3 active arms) to prevent NIV-induced skin injury
Eligibility Criteria
You may qualify if:
- Hypoxemic-hypercapnic acute respiratory failure (while in O2-therapy):
- pH\<7.30,
- PaCO2\>50 mmHg,
- PaO2/FiO2\<250,
- respiratory rate\>25/min and use of accessory respiratory muscles
- Pure Hypoxemic acute respiratory failure(while in O2-therapy):
- pH\>7.35
- PaCO2\< 50 mmHg
- PaO2/FiO2\<250
- respiratory rate\>25/min and use of accessory respiratory muscles
- For both types of acute respiratory failure: Signed informed consent by the patient or next keen. Age more than 20 year's old
You may not qualify if:
- cardiac arrest
- severe hemodynamic instability (\> 1 vasoactive amine for more than 24 hours)
- acute coronary syndrome (instable angina/AMI)
- refusal of NIV
- anatomic abnormalities interfering with mask fitting
- pre-existent nasal lesions;
- NIV for\< 24 hours
- kwon hypersensitivity to hydrocolloid and polyurethane
- cancel of informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ospedale San Donatolead
- Smith & Nephew, Inc.collaborator
- Italian Association of Hospital Pneumologistscollaborator
Study Sites (1)
Pulmonary Division With Respiratory Intensive Care Unit, S. Donato Hospital, Arezzo, Italy
Lucca, 55100, Italy
Related Publications (1)
Weng MH. The effect of protective treatment in reducing pressure ulcers for non-invasive ventilation patients. Intensive Crit Care Nurs. 2008 Oct;24(5):295-9. doi: 10.1016/j.iccn.2007.11.005. Epub 2008 Feb 1.
PMID: 18242994RESULT
Study Officials
- STUDY CHAIR
Raffaele Scala, MD, FCCP
PULMONARY DIVISION WITH RESPIRATORY INTENSIVE CARE UNIT, S. DONATO HOSPITAL, AREZZO, ITALY
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
May 5, 2011
First Posted
May 10, 2011
Study Start
December 1, 2011
Primary Completion
May 1, 2015
Study Completion
October 1, 2015
Last Updated
December 31, 2014
Record last verified: 2014-12