Noninvasive Positive Airway Pressure Ventilation and Risk of Facial Pressure Ulcers

Completed

• Conditions: Acute Respiratory Failure
• Interventions: Device: Noninvasive ventilation mask

• Registration Number: NCT01828151
• Lead Sponsor: Ospedale S. Giovanni Bosco

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.

Study Timeline

• Study Start: 2009-12
• Primary Completion: 2011-12
• Study Completion: 2013-03
• Study First Submitted: 2013-03-21
• Status Verified: 2013-04
• Study First Submitted QC: 2013-04-05
• Last Update Submitted: 2013-04-05
• Study First Posted: 2013-04-10
• Last Update Posted: 2013-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 170

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Developed skin lesions	Noninvasive ventilation mask	Patients treated with noninvasive ventilation for an episode of acute respiratory failure

Primary Outcome Measures

Name	Time	Method
Risk of skin pressure ulcers in patients treated with noninvasive ventilation for acute respiratory failure.	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 Outcome Measures

Name	Time	Method
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.	Characterization of skin lesions during noninvasive ventilation in patients with acute respiratory failure.

Trial Locations

Locations (1)

Medicina d'Urgenza - Terapia Subintensiva. Ospedale S. Giovanni Bosco; 🇮🇹 Torino, Italy