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OpenTrials
Completed

NCT Number: NCT01828151

Noninvasive Positive Airway Pressure Ventilation and Risk of Facial Pressure Ulcers

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

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Key information

Conditions

Acute Respiratory Failure Pressure Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medicina d'Urgenza - Terapia Subintensiva. Ospedale S. Giovanni Bosco

Torino, 10154, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Noninvasive ventilation mask

Device

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Ospedale S. Giovanni Bosco

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2013
First posted
Apr 10, 2013
Registry last updated
Apr 10, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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