Acute Respiratory FailureNCT01828151
Noninvasive Positive Airway Pressure Ventilation and Risk of Facial Pressure Ulcers
An observational study of Acute Respiratory Failure, run by Ospedale S. Giovanni Bosco at 1 site in Italy.
Trial summary
To assess risk of skin pressure lesions in patients treated with noninvasive mechanical ventilation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Failure
- What is being tested?
- Noninvasive ventilation mask
- Type of treatment
- Medical device
- How many people
- 170 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2009to Mar 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to our high dependency unit for an episode of acute respiratory failure and treated with noninvasive ventilation.
Who may be able to join
- 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
Who cannot join
- STEMI
- NSTEMI/Unstable angina
- Hemodynamic instability
- Need for immediate endotracheal intubation
- Inability to protect the airways
- Impaired sensorium
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- Pulmonary embolism
- Gastrointestinal bleeding
- Hematological malignancy or neoplasms with ECOG performance status > 2
Trial locations and contacts
1 site in 1 country.
Italy1 site
Medicina d'Urgenza - Terapia Subintensiva. Ospedale S. Giovanni Bosco
Torino, Torino, 10154
About this study
Official title: 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.
Read the 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.
- Conditions
- Acute Respiratory Failure
- Being tested
- Noninvasive ventilation mask
- Keywords
- Pressure ulcer, Noninvasive ventilation
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Noninvasive ventilation maskDevice
Also called - Oro-nasal mask: Ultra Mirage NV, ResMed Australia, - Full-face mask: Performax, Respironics Inc USA, - Helmet: Castar R, StarMed - Mirandola Italy
| Study group | Role | What they receive |
|---|---|---|
| Developed skin lesions | Patients treated with noninvasive ventilation for an episode of acute respiratory failure Receives: Device: Noninvasive ventilation mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Risk of pressure ulcers within 72 hours from noninvasive ventilation beginning.
Secondary outcomes (1)
Incidence of skin pressure ulcers in patients treated with noninvasive ventilation.
Characterization of skin lesions during noninvasive ventilation in patients with acute respiratory failure.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2013 (estimated)
- Study startDec 2009
- Primary completionDec 2011
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ospedale S. Giovanni Bosco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giovanni Ferrari, Ospedale S. Giovanni Bosco
- Investigators
- Giovanni Ferrari, MD, Principal investigator, Ospedale S. Giovanni Bosco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01828151
- Sponsor's protocol ID
- gbosco5
- Status last verified
- Apr 2013
- First submitted
- 21 Mar 2013
- Last updated
- 10 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Positive Airway Pressure Ventilation and Risk of Facial Pressure Ulcers in Patients With Acute Respiratory Failure
- ClinicalTrials.gov ID
- NCT01828151
- Acronym / sponsor ID
- gbosco5
- Conditions
- Acute Respiratory Failure
- Keywords
- Pressure ulcer, Noninvasive ventilation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Ospedale S. Giovanni BoscoUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 10 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Developed skin lesions | – | Device: Noninvasive ventilation maskPatients treated with noninvasive ventilation for an episode of acute respiratory failure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to our high dependency unit for an episode of acute respiratory failure and treated with noninvasive ventilation.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- STEMI
- NSTEMI/Unstable angina
- Hemodynamic instability
- Need for immediate endotracheal intubation
- Inability to protect the airways
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Noninvasive ventilation maskAlso: - Oro-nasal mask: Ultra Mirage NV, ResMed Australia, - Full-face mask: Performax, Respironics Inc USA, - Helmet: Castar R, StarMed - Mirandola Italy | Device | Developed skin lesions |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giovanni Ferrari, MD principal investigator
Ospedale S. Giovanni Bosco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Failure, run by Ospedale S. Giovanni Bosco at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2013.