Noninvasive Positive Airway Pressure Ventilation and Risk of Facial Pressure Ulcers

Acute Respiratory Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01828151
• Other study ID #: gbosco5
• Status: Completed
• Phase: N/A
• First received: March 21, 2013
• Last updated: April 5, 2013
• Start date: December 2009
• Est. completion date: March 2013

Study information

• Verified date: April 2013
• Source: Ospedale S. Giovanni Bosco
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: March 2013
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Pressure Ulcer
• Respiratory Distress Syndrome, Adult
• Respiratory Insufficiency

Intervention

Device:
• Noninvasive ventilation mask

Locations

Country	Name	City	State
Italy	Medicina d'Urgenza - Terapia Subintensiva. Ospedale S. Giovanni Bosco	Torino

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale S. Giovanni Bosco

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	Incidence of skin pressure ulcers in patients treated with noninvasive ventilation.	Characterization of skin lesions during noninvasive ventilation in patients with acute respiratory failure.	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.	No