Noninvasive Positive Airway Pressure Ventilation and Risk of Facial Pressure Ulcers

Study Overview
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Brief Summary
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To assess risk of skin pressure lesions in patients treated with noninvasive mechanical ventilation.

Detailed Description
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Noninvasive ventilation improves the outcome of patients with acute respiratory failure; however patient's discomfort may be responsible for up to a fifth of failures. Scant literature exists on NIV-related pressure ulcers and their determinants. Aim of the study is to seek for determinants, if any, associated with the development of pressure ulcers related to noninvasive ventilation. Study design: observational. Patients treated with NIV from December 2009 to December 2011 will be analyzed. Main end-points: to seek for variables associated to the development of NIV-related pressure ulcers in patients with acute respiratory failure.

Official Title
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Noninvasive Positive Airway Pressure Ventilation and Risk of Facial Pressure Ulcers in Patients With Acute Respiratory Failure

Conditions
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Acute Respiratory Failure

Intervention / Treatment
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* Device: Noninvasive ventilation mask


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: severe dyspnea at rest respiratory rate > 30 per minute PaO2/FiO2 < 200 (despite oxygen with Venturi with a FiO2 og 0.5) use of accessory respiratory muscles pH < 7.35 > 7.10 Exclusion Criteria: STEMI NSTEMI/Unstable angina Hemodynamic instability Need for immediate endotracheal intubation Inability to protect the airways Impaired sensorium Pulmonary embolism Gastrointestinal bleeding Hematological malignancy or neoplasms with ECOG performance status > 2

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Developed skin lesions<br>Patients treated with noninvasive ventilation for an episode of acute respiratory failure | Device: Noninvasive ventilation mask<br> <br> * Other names: - Helmet: Castar R, StarMed - Mirandola Italy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk of skin pressure ulcers in patients treated with noninvasive ventilation for acute respiratory failure. | Skin lesions were classified as follows: reddening, loss of skin integrity, necrotic lesion. | Risk of pressure ulcers within 72 hours from noninvasive ventilation beginning. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of skin pressure ulcers in patients treated with noninvasive ventilation. | Characterization of skin lesions during noninvasive ventilation in patients with acute respiratory failure. | Incidence of skin pressure ulcers. Patients will be followed during duration of high dependency unit stay for an average length of stay of 7 days. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pressure ulcer, Noninvasive ventilation