Noninvasive Positive Airway Pressure Ventilation and Risk of Facial Pressure Ulcers
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|ClinicalTrials.gov Identifier: NCT01828151|
Recruitment Status : Completed
First Posted : April 10, 2013
Last Update Posted : April 10, 2013
|Condition or disease||Intervention/treatment|
|Acute Respiratory Failure||Device: Noninvasive ventilation mask|
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.
|Study Type :||Observational|
|Actual Enrollment :||170 participants|
|Official Title:||Noninvasive Positive Airway Pressure Ventilation and Risk of Facial Pressure Ulcers in Patients With Acute Respiratory Failure|
|Study Start Date :||December 2009|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||March 2013|
Developed skin lesions
Patients treated with noninvasive ventilation for an episode of acute respiratory failure
Device: Noninvasive ventilation mask
- Risk of skin pressure ulcers in patients treated with noninvasive ventilation for acute respiratory failure. [ Time Frame: Risk of pressure ulcers within 72 hours from noninvasive ventilation beginning. ]
Skin lesions were classified as follows:
- loss of skin integrity,
- necrotic lesion.
- Incidence of skin pressure ulcers in patients treated with noninvasive ventilation. [ Time Frame: 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. ]Characterization of skin lesions during noninvasive ventilation in patients with acute respiratory failure.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01828151
|Medicina d'Urgenza - Terapia Subintensiva. Ospedale S. Giovanni Bosco|
|Torino, Italy, 10154|
|Principal Investigator:||Giovanni Ferrari, MD||Ospedale S. Giovanni Bosco|