Noninvasive Positive Airway Pressure Ventilation and Risk of Facial Pressure Ulcers

NCT01828151 | Completed

• 1 other identifier: gbosco5
• Study Type: observational
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acute Respiratory Failure

Keywords

Pressure ulcer; Noninvasive ventilation

Outcome Measures

Primary Outcomes (1)

• Risk of skin pressure ulcers in patients treated with noninvasive ventilation for acute respiratory failure.

  Skin lesions were classified as follows: * reddening, * loss of skin integrity, * necrotic lesion.

  Risk of pressure ulcers within 72 hours from noninvasive ventilation beginning.

Secondary Outcomes (1)

• 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 Arms (1)

Developed skin lesions

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

Device: Noninvasive ventilation mask

Interventions

Noninvasive ventilation mask DEVICE

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

Developed skin lesions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ospedale S. Giovanni Bosco: lead

Study Sites (1)

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

Torino, Torino, 10154, Italy

Location

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Giovanni Ferrari, MD

  Ospedale S. Giovanni Bosco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: March 21, 2013
• First Posted: April 10, 2013
• Study Start: December 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: March 1, 2013
• Last Updated: April 10, 2013

Record last verified: 2013-04

Locations

IT (1)