Noninvasive Positive Airway Pressure Ventilation and Risk of Facial Pressure Ulcers

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01828151

Enrollment

170

Registered

2013-04-10

Start date

2009-12-31

Completion date

2013-03-31

Last updated

2013-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Failure

Keywords

Pressure ulcer, Noninvasive ventilation

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.

Interventions

DEVICENoninvasive ventilation mask

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026