Noninvasive Positive Airway Pressure Ventilation and Risk of Facial Pressure Ulcers

April 5, 2013 updated by: Giovanni Ferrari, Ospedale S. Giovanni Bosco

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

170

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Torino, Italy, 10154
        • Medicina d'Urgenza - Terapia Subintensiva. Ospedale S. Giovanni Bosco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

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

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Developed skin lesions
Patients treated with noninvasive ventilation for an episode of acute respiratory failure
Device: Noninvasive ventilation mask
Other Names:
  • - Oro-nasal mask: Ultra Mirage NV, ResMed Australia
  • - Full-face mask: Performax, Respironics Inc USA
  • - Helmet: Castar R, StarMed - Mirandola Italy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Risk of skin pressure ulcers in patients treated with noninvasive ventilation for acute respiratory failure.
Time Frame: Risk of pressure ulcers within 72 hours from noninvasive ventilation beginning.

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of skin pressure ulcers in patients treated with noninvasive ventilation.
Time Frame: 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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ospedale S. Giovanni Bosco

Investigators

  • Principal Investigator: Giovanni Ferrari, MD, Ospedale S. Giovanni Bosco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (ACTUAL)

December 1, 2011

Study Completion (ACTUAL)

March 1, 2013

Study Registration Dates

First Submitted

March 21, 2013

First Submitted That Met QC Criteria

April 5, 2013

First Posted (ESTIMATE)

April 10, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

April 10, 2013

Last Update Submitted That Met QC Criteria

April 5, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • gbosco5

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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