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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
Sponsor:
Information provided by (Responsible Party):
Giovanni Ferrari, Ospedale S. Giovanni Bosco

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

Condition or disease Intervention/treatment
Acute Respiratory Failure Device: Noninvasive ventilation mask

Detailed Description:

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 Design
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Study Type : Observational
Actual Enrollment : 170 participants
Observational Model: Cohort
Time Perspective: Retrospective
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

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Groups and Cohorts
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Group/Cohort Intervention/treatment
Developed skin lesions
Patients treated with noninvasive ventilation for an episode of acute respiratory failure
 Device: Noninvasive ventilation mask
Other Names:
  • - Oro-nasal mask: Ultra Mirage NV, ResMed Australia
  • - Full-face mask: Performax, Respironics Inc USA
  • - Helmet: Castar R, StarMed - Mirandola Italy


Outcome Measures
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Primary Outcome Measures :
  1. 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:

    • reddening,
    • loss of skin integrity,
    • necrotic lesion.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients admitted to our high dependency unit for an episode of acute respiratory failure and treated with noninvasive ventilation.
Criteria

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
Contacts and Locations
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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


Locations
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Italy
Medicina d'Urgenza - Terapia Subintensiva. Ospedale S. Giovanni Bosco
Torino, Italy, 10154
Sponsors and Collaborators
Ospedale S. Giovanni Bosco
Investigators
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Principal Investigator: Giovanni Ferrari, MD Ospedale S. Giovanni Bosco
More Information
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Responsible Party: Giovanni Ferrari, Dr, Ospedale S. Giovanni Bosco
ClinicalTrials.gov Identifier: NCT01828151    
Other Study ID Numbers: gbosco5
First Posted: April 10, 2013    Key Record Dates
Last Update Posted: April 10, 2013
Last Verified: April 2013
Keywords provided by Giovanni Ferrari, Ospedale S. Giovanni Bosco:
Pressure ulcer
Noninvasive ventilation
Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiratory Distress Syndrome, Adult
Pressure Ulcer
Respiration Disorders
 Respiratory Tract Diseases
Skin Ulcer
Skin Diseases
Lung Diseases