Acute Respiratory Failure3PROSNIVNCT01351155
Prevention of Damage Induced by Facial Mask Ventilation
A study testing Skin protective dressing device in people with Acute Respiratory Failure, run by Ospedale San Donato at 1 site in Italy.
Trial summary
In patients with acute respiratory failure (ARF) undergoing noninvasive ventilation (NIV), the main complication of the use of the mask is the development of decubitus, sometimes so severe and painful as to force a suspension of the NIV itself . Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Acute Respiratory Failure
- What is being tested?
- Skin protective dressing device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2011to Oct 2015
- Phase
- Interventional
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hypoxemic-hypercapnic acute respiratory failure (while in O2-therapy):
- pH<7.30,
- PaCO2>50 mmHg,
- PaO2/FiO2<250,
- respiratory rate>25/min and use of accessory respiratory muscles
- Pure Hypoxemic acute respiratory failure(while in O2-therapy):
Show all 11Show fewer
- pH>7.35
- PaCO2< 50 mmHg
- PaO2/FiO2<250
- respiratory rate>25/min and use of accessory respiratory muscles
- For both types of acute respiratory failure: Signed informed consent by the patient or next keen. Age more than 20 year's old
Who cannot join
- cardiac arrest
- severe hemodynamic instability (> 1 vasoactive amine for more than 24 hours)
- acute coronary syndrome (instable angina/AMI)
- refusal of NIV
- anatomic abnormalities interfering with mask fitting
- pre-existent nasal lesions;
Show all 9Show fewer
- NIV for< 24 hours
- kwon hypersensitivity to hydrocolloid and polyurethane
- cancel of informed consent
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Pulmonary Division With Respiratory Intensive Care Unit, S. Donato Hospital, Arezzo, Italy
Lucca, 55100
raffaele_scala@hotmail.com
Raffaele Scala, MD, FCCP
About this study
Official title: Comparison of Three Devices to Prevent Skin Damage Induced by Facial Mask Ventilation During Acute Respiratory Failure: a Multicenter Randomised Controlled Study
In patients with acute respiratory failure (ARF) undergoing noninvasive ventilation (NIV), the main complication of the use of the mask is the development of decubitus, sometimes so severe and painful as to force a suspension of the NIV itself . The lesions are mainly located at the nasal bridge, as at this level the skin thin and placed directly on the bone is particularly vulnerable to the injury as consequence of the friction and pressure induced by the movement of the mask. The strategy of prevention and treatment commonly adopted is the application of hydrocolloids.
However, precise data are lacking about the demonstration of the effectiveness of these devices and the possibility of using other protective devices.
The purpose of this study was to evaluate the usefulness of large-scale three different systems of protection vs. no protection in preventing the development of decubitus lesions in patients receiving NIV for an episode of ARF.
Read the detailed description
NIV is a form of ventilatory support which is popular overall in the world. The patient interface most commonly used in the course of NIV is by far the nasal or oronasal mask. The main complication of the use of the mask is the development of decubitus, sometimes so severe and painful as to force a suspension of NIV. The decubitus is mainly located at the nasal bridge, as at this level the skin thin and placed directly on the bone. According to Meduri et al.(Chest 1996) the duration of NIV, age, type of respiratory failure, the pressure used for ventilation and the level of albumin did not influence the development of necrosis.
Severe skin injury with ulceration and necrosis occurs in approximately 10% of patients receiving NIV trained in services. In the multicenter evaluation of a new face mask dedicated to the NIV (Gregoretti et al, Intens Care Med 2002) describes the development of NIV-induced decubitus in 100% of the control group treated with masks "traditional", with an average grade of 2.79 on a scale of Assessment Standard ranging from 1 (erythema) to 4 (necrosis).
The strategy of prevention and treatment commonly adopted is the application of appropriately shaped hydrocolloids. However, the data relating to the use of protective systems for the prevention of NIV-induced decubitus are limited and controversial. In a first pilot study (Callaghan et al,Professional Nurse 1998, the authors compared the protective efficacy of two types of "dressing" (Granuflex, Spenco Dermal and 10 patients, 10 patients) vs a non-randomized control group (10 patients): 30 patients in total . In this work, which presents a problem of inter-observer variability, the "Granuflex group" (or Duoderm) showed a greater protective effect (3 vs. 7 lesions in "Spenco Dermal group" vs 9 lesions in the control group). Recently, in a larger study, Weng (Intensive Crit Care Nurs 2008) compared the efficacy of two devices (Tegaderm and tegasorb) vs. a control group in 90 patients (30 per group) undergoing NIV. The rate of lesions was significantly lower in the treated groups (53% Tegaderm; Tegasorb 40%) than in the control group (96.7%), with no significant difference between the two interventional arms on both the incidence and the timing of onset of injury.
Therefore, given the limited data currently available regarding both the effectiveness and the choice of a protective device and in consideration of the continuous expansion of NIV in the acute setting, in our opinion it's seems to us justified to perform a controlled study comparing different types of devices in terms of skin protection during NIV.
- Conditions
- Acute Respiratory Failure
- Being tested
- Skin protective dressing device
- Keywords
- acute respiratory failure, noninvasive ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin protective dressing deviceDevice
Application of one the three indicated devices (3 active arms) to prevent NIV-induced skin injury
| Study group | Role | What they receive |
|---|---|---|
| polyurethane foam (Allewyn adesive) | Active comparator | Polyurethane foam is applied as skin protective dressing device before NIV and kept on site till the 7th day of treatment Intervention: active prophilactic barrier against skin breakdown Receives: Device: Skin protective dressing device |
| polyurethane film (Tegaderm) | Active comparator | The polyurethane film is applied ss skin protective dressing device before NIV and kept on site till the 7th day of treatment Intervention: active prophilactic barrier against skin breakdown Receives: Device: Skin protective dressing device |
| Hydrocolloid (Duoderm) | Active comparator | Hydrocolloid is applied ss skin protective dressing device before NIV and kept on site till the 7th day of treatment Intervention: active prophilactic barrier against skin breakdown Receives: Device: Skin protective dressing device |
| Control | No intervention | In this no-intervention arm, any skin protective dressing devices is applied before NIV starting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Failure rate of the prevention of the facial mask ventilation-induced skin damage in the three interventional groups and in the control group
Measured: 7 days
Secondary outcomes (4)
Mask-induced discomfort
Discomfort/pain consequent to NIV-induced skin damage with the different protective devices
Measured: 7 days
Costs for skin protection
Amounts of costs due to prevention of NIV-induced skin damage with the different protective devices
Measured: 7 days
Prediction of NIV-induced skin damage
Identification of the variables independently associated with the development of skin injury due to mask ventilation
Measured: 7 days
Success of NIV
Rate of success of NIV to avoid endotracheal intubation and death
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2011 (estimated)
- Study startDec 2011
- Primary completionMay 2015 (estimated)
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 252 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ospedale San Donato
- Sponsor type
- University, hospital or other
- Collaborators
- Smith & Nephew, Inc., Italian Association of Hospital Pneumologists
- Responsible party
- Principal investigator, Raffaele Scala, Ospedale San Donato
- Investigators
- Raffaele Scala, MD, FCCP, Study chair, PULMONARY DIVISION WITH RESPIRATORY INTENSIVE CARE UNIT, S. DONATO HOSPITAL, AREZZO, ITALY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01351155
- Sponsor's protocol ID
- RSAIPO2011
- Acronym
- 3PROSNIV
- Status last verified
- Dec 2014
- First submitted
- 5 May 2011
- Last updated
- 31 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Weng MH. The effect of protective treatment in reducing pressure ulcers for non-invasive ventilation patients. Intensive Crit Care Nurs. 2008 Oct;24(5):295-9. doi: 10.1016/j.iccn.2007.11.005. Epub 2008 Feb 1.
PubMed 18242994Scala R, Andolfi F, Ottaviano G, Renda T, Ceparano E, Caneschi M, Guidelli L, Vega ML, Pisani L, Bassi I, Aprile A, Bertini S, Bonanni D, Zoccali P, Vitacca M, Barbano L, Ferrandez MT, Lopez AR, Villa GR, Marchese SA, Lo Grasso G, Fiandra E, Scoscia E, Eslami A, Albo E, Baglioni S, Facciolongo N, Castagnetti C, Barbieri C, Boccafoglio F, Viola S, Esquinas AM. Comparison of Three Devices Preventing Skin Damage During Facial Mask Ventilation in Acute Respiratory Failure: Multicenter Randomized Controlled Trial Protocol (3PROSNIVtrial). Pulm Ther. 2026 Jun;12(2):721-731. doi: 10.1007/s41030-026-00364-z. Epub 2026 May 17.
PubMed 42143659
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Three Devices to Prevent Skin Damage Induced by Facial Mask Ventilation During Acute Respiratory Failure: a Multicenter Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT01351155
- Acronym / sponsor ID
- 3PROSNIV / RSAIPO2011
- Conditions
- Acute Respiratory Failure
- Keywords
- acute respiratory failure, noninvasive ventilation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 252 participants (estimated)
- Lead sponsor
- Ospedale San DonatoUniversity, hospital or other
- Collaborators
- Smith & Nephew, Inc., Italian Association of Hospital Pneumologists
- Study start
- Dec 2011
- Primary completion
- May 2015 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 10 May 2011 (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.
In patients with acute respiratory failure (ARF) undergoing noninvasive ventilation (NIV), the main complication of the use of the mask is the development of decubitus, sometimes so severe and painful as to force a suspension of the NIV itself . The lesions are mainly located at the nasal bridge, as at this level the skin thin and placed directly on the bone is particularly vulnerable to the injury as consequence of the friction and pressure induced by the movement of the mask. The strategy of prevention and treatment commonly adopted is the application of hydrocolloids.
However, precise data are lacking about the demonstration of the effectiveness of these devices and the possibility of using other protective devices.
The purpose of this study was to evaluate the usefulness of large-scale three different systems of protection vs. no protection in preventing the development of decubitus lesions in patients receiving NIV for an episode of ARF.
Detailed description
NIV is a form of ventilatory support which is popular overall in the world. The patient interface most commonly used in the course of NIV is by far the nasal or oronasal mask. The main complication of the use of the mask is the development of decubitus, sometimes so severe and painful as to force a suspension of NIV. The decubitus is mainly located at the nasal bridge, as at this level the skin thin and placed directly on the bone. According to Meduri et al.(Chest 1996) the duration of NIV, age, type of respiratory failure, the pressure used for ventilation and the level of albumin did not influence the development of necrosis.
Severe skin injury with ulceration and necrosis occurs in approximately 10% of patients receiving NIV trained in services. In the multicenter evaluation of a new face mask dedicated to the NIV (Gregoretti et al, Intens Care Med 2002) describes the development of NIV-induced decubitus in 100% of the control group treated with masks "traditional", with an average grade of 2.79 on a scale of Assessment Standard ranging from 1 (erythema) to 4 (necrosis).
The strategy of prevention and treatment commonly adopted is the application of appropriately shaped hydrocolloids. However, the data relating to the use of protective systems for the prevention of NIV-induced decubitus are limited and controversial. In a first pilot study (Callaghan et al,Professional Nurse 1998, the authors compared the protective efficacy of two types of "dressing" (Granuflex, Spenco Dermal and 10 patients, 10 patients) vs a non-randomized control group (10 patients): 30 patients in total . In this work, which presents a problem of inter-observer variability, the "Granuflex group" (or Duoderm) showed a greater protective effect (3 vs. 7 lesions in "Spenco Dermal group" vs 9 lesions in the control group). Recently, in a larger study, Weng (Intensive Crit Care Nurs 2008) compared the efficacy of two devices (Tegaderm and tegasorb) vs. a control group in 90 patients (30 per group) undergoing NIV. The rate of lesions was significantly lower in the treated groups (53% Tegaderm; Tegasorb 40%) than in the control group (96.7%), with no significant difference between the two interventional arms on both the incidence and the timing of onset of injury.
Therefore, given the limited data currently available regarding both the effectiveness and the choice of a protective device and in consideration of the continuous expansion of NIV in the acute setting, in our opinion it's seems to us justified to perform a controlled study comparing different types of devices in terms of skin protection during NIV.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| polyurethane foam (Allewyn adesive) | Active comparator | Device: Skin protective dressing devicePolyurethane foam is applied as skin protective dressing device before NIV and kept on site till the 7th day of treatment Intervention: active prophilactic barrier against skin breakdown |
| polyurethane film (Tegaderm) | Active comparator | Device: Skin protective dressing deviceThe polyurethane film is applied ss skin protective dressing device before NIV and kept on site till the 7th day of treatment Intervention: active prophilactic barrier against skin breakdown |
| Hydrocolloid (Duoderm) | Active comparator | Device: Skin protective dressing deviceHydrocolloid is applied ss skin protective dressing device before NIV and kept on site till the 7th day of treatment Intervention: active prophilactic barrier against skin breakdown |
| Control | No intervention | –In this no-intervention arm, any skin protective dressing devices is applied before NIV starting |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Hypoxemic-hypercapnic acute respiratory failure (while in O2-therapy):
- Pure Hypoxemic acute respiratory failure(while in O2-therapy):
- For both types of acute respiratory failure: Signed informed consent by the patient or next keen. Age more than 20 year's old
Key exclusion criteria (9 listed)
- cardiac arrest
- severe hemodynamic instability (> 1 vasoactive amine for more than 24 hours)
- acute coronary syndrome (instable angina/AMI)
- refusal of NIV
- anatomic abnormalities interfering with mask fitting
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 |
|---|---|---|
| Skin protective dressing deviceApplication of one the three indicated devices (3 active arms) to prevent NIV-induced skin injury | Device | Hydrocolloid (Duoderm), polyurethane film (Tegaderm), polyurethane foam (Allewyn adesive) |
Primary outcome
Failure rate of the prevention of the facial mask ventilation-induced skin damage in the three interventional groups and in the control group
Time frame: 7 days
4 secondary outcomes
Mask-induced discomfort
Time frame: 7 days
Costs for skin protection
Time frame: 7 days
Prediction of NIV-induced skin damage
Time frame: 7 days
Success of NIV
Time frame: Up to 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2014.
- Results publication: PubMed 18242994Weng MH. The effect of protective treatment in reducing pressure ulcers for non-invasive ventilation patients. Intensive Crit Care Nurs. 2008 Oct;24(5):295-9. doi: 10.1016/j.iccn.2007.11.005. Epub 2008 Feb 1.
- Derived from this study: PubMed 42143659Scala R, Andolfi F, Ottaviano G, Renda T, Ceparano E, Caneschi M, Guidelli L, Vega ML, Pisani L, Bassi I, Aprile A, Bertini S, Bonanni D, Zoccali P, Vitacca M, Barbano L, Ferrandez MT, Lopez AR, Villa GR, Marchese SA, Lo Grasso G, Fiandra E, Scoscia E, Eslami A, Albo E, Baglioni S, Facciolongo N, Castagnetti C, Barbieri C, Boccafoglio F, Viola S, Esquinas AM. Comparison of Three Devices Preventing Skin Damage During Facial Mask Ventilation in Acute Respiratory Failure: Multicenter Randomized Controlled Trial Protocol (3PROSNIVtrial). Pulm Ther. 2026 Jun;12(2):721-731. doi: 10.1007/s41030-026-00364-z. Epub 2026 May 17.
Related trials for Acute Respiratory Failure
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Not yet recruiting
Regional Lung Ventilation During Prone Position in in Intubated Children
Pediatric Acute Respiratory Failure
Not yet recruiting
Influence of Patient Positioning During Nasal Lavage
Acute Upper Respiratory Tract Infections, Nasal Obstruction
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Not yet recruiting
ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers
Acute Respiratory Failure, Critical Illness
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.
Raffaele Scala, MD, FCCP study chair
PULMONARY DIVISION WITH RESPIRATORY INTENSIVE CARE UNIT, S. DONATO HOSPITAL, AREZZO, ITALY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skin protective dressing device in people with Acute Respiratory Failure, run by Ospedale San Donato 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 11 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: status not confirmed, as of the sponsor's last update on 31 Dec 2014. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Raffaele Scala, MD, FCCP (+39 3482605980, raffaele_scala@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Failure rate of the prevention of the facial mask ventilation-induced skin damage in the three interventional groups and in the control group (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01351155, which also lists 2 linked publications.
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 31 Dec 2014.