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Noninvasive Positive Airway Pressure Ventilation and Risk of Facial Pressure Ulcers

O

Ospedale S. Giovanni Bosco

Status

Completed

Conditions

Acute Respiratory Failure

Treatments

Device: Noninvasive ventilation mask

Study type

Observational

Funder types

Other

Identifiers

NCT01828151
gbosco5

Details and patient eligibility

About

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

Full 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.

Enrollment

170 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

170 participants in 1 patient group

Developed skin lesions
Description:
Patients treated with noninvasive ventilation for an episode of acute respiratory failure
Treatment:
Device: Noninvasive ventilation mask

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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