Completed

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

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What is being collected

Device Data

Collected from past medical records and data - Retrospective
Device
Who is being recruted

Skin Diseases+1

+ Skin Ulcer

+ Skin and Connective Tissue Diseases

Over 18 Years
+14 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: December 2009
See protocol details

Summary

Principal SponsorOspedale S. Giovanni Bosco
Last updated: April 10, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 2009

Actual date on which the first participant was enrolled.

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.

NCT01828151
Principal SponsorOspedale S. Giovanni Bosco
Last updated: April 10, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

170 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Skin DiseasesSkin UlcerSkin and Connective Tissue DiseasesPressure Ulcer

Criteria

5 inclusion criteria required to participate
PaO2/FiO2 < 200 (despite oxygen with Venturi with a FiO2 og 0.5)
pH < 7.35 > 7.10
respiratory rate > 30 per minute
severe dyspnea at rest
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9 exclusion criteria prevent from participating
Gastrointestinal bleeding
Hematological malignancy or neoplasms with ECOG performance status > 2
Hemodynamic instability
Impaired sensorium
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

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

Torino, ItalyOpen Medicina d'Urgenza - Terapia Subintensiva. Ospedale S. Giovanni Bosco in Google Maps
CompletedOne Study Center
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