Noninvasive Positive Airway Pressure Ventilation and Risk of Facial Pressure Ulcers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

170 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-12-31

Study Completion Date

2013-03-31

Brief Summary

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To assess risk of skin pressure lesions in patients treated with noninvasive mechanical ventilation.

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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.

Conditions

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Acute Respiratory Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Developed skin lesions

Patients treated with noninvasive ventilation for an episode of acute respiratory failure

Noninvasive ventilation mask

Intervention Type DEVICE

Interventions

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Noninvasive ventilation mask

Intervention Type DEVICE

Other Intervention Names

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- Oro-nasal mask: Ultra Mirage NV, ResMed Australia - Full-face mask: Performax, Respironics Inc USA - Helmet: Castar R, StarMed - Mirandola Italy

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No