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Clinical Trials/NCT01828151
NCT01828151
Completed
Not Applicable

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

Ospedale S. Giovanni Bosco1 site in 1 country170 target enrollmentDecember 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Respiratory Failure
Sponsor
Ospedale S. Giovanni Bosco
Enrollment
170
Locations
1
Primary Endpoint
Risk of skin pressure ulcers in patients treated with noninvasive ventilation for acute respiratory failure.
Status
Completed
Last Updated
13 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
December 2009
End Date
March 2013
Last Updated
13 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Ospedale S. Giovanni Bosco
Responsible Party
Principal Investigator
Principal Investigator

Giovanni Ferrari

Dr

Ospedale S. Giovanni Bosco

Eligibility 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

  • 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

Outcomes

Primary Outcomes

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

  • Incidence of skin pressure ulcers in patients treated with noninvasive ventilation.(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.)

Study Sites (1)

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