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Prevention of Damage Induced by Facial Mask Ventilation (3PROSNIV)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2012 by Ospedale San Donato.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Smith & Nephew, Inc.
Italian Association of Hospital Pneumologists
Information provided by (Responsible Party):
Raffaele Scala, Ospedale San Donato
ClinicalTrials.gov Identifier:
NCT01351155
First received: May 5, 2011
Last updated: November 30, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention
Acute Respiratory Failure
Device: Skin protective dressing device

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Comparison of Three Devices to Prevent Skin Damage Induced by Facial Mask Ventilation During Acute Respiratory Failure: a Multicenter Randomised Controlled Study

Resource links provided by NLM:


Further study details as provided by Ospedale San Donato:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Mask-induced discomfort [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Discomfort/pain consequent to NIV-induced skin damage with the different protective devices

  • Costs for skin protection [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Amounts of costs due to prevention of NIV-induced skin damage with the different protective devices

  • Prediction of NIV-induced skin damage [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Identification of the variables independently associated with the development of skin injury due to mask ventilation

  • Success of NIV [ Time Frame: Up to 30 days ] [ Designated as safety issue: No ]
    Rate of success of NIV to avoid endotracheal intubation and death


Estimated Enrollment: 252
Study Start Date: December 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: polyurethane foam (Allewyn adesive)
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
Device: Skin protective dressing device
Application of one the three indicated devices (3 active arms) to prevent NIV-induced skin injury
Active Comparator: polyurethane film (Tegaderm)
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
Device: Skin protective dressing device
Application of one the three indicated devices (3 active arms) to prevent NIV-induced skin injury
Active Comparator: Hydrocolloid (Duoderm)
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
Device: Skin protective dressing device
Application of one the three indicated devices (3 active arms) to prevent NIV-induced skin injury
No Intervention: Control
In this no-intervention arm, any skin protective dressing devices is applied before NIV starting

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hypoxemic-hypercapnic acute respiratory failure (while in O2-therapy):

    1. pH<7.30,
    2. PaCO2>50 mmHg,
    3. PaO2/FiO2<250,
    4. respiratory rate>25/min and use of accessory respiratory muscles
  • Pure Hypoxemic acute respiratory failure(while in O2-therapy):

    1. pH>7.35
    2. PaCO2< 50 mmHg
    3. PaO2/FiO2<250
    4. 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

Exclusion Criteria:

  1. cardiac arrest
  2. severe hemodynamic instability (> 1 vasoactive amine for more than 24 hours)
  3. acute coronary syndrome (instable angina/AMI)
  4. refusal of NIV
  5. anatomic abnormalities interfering with mask fitting
  6. pre-existent nasal lesions;
  7. NIV for< 24 hours
  8. kwon hypersensitivity to hydrocolloid and polyurethane
  9. cancel of informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01351155

Contacts
Contact: Raffaele Scala, MD, FCCP +39 3482605980 raffaele_scala@hotmail.com

Locations
Italy
Pulmonary Division With Respiratory Intensive Care Unit, S. Donato Hospital, Arezzo, Italy Recruiting
Lucca, Italy, 55100
Contact       raffaele_scala@hotmail.com   
Principal Investigator: Raffaele Scala, MD, FCCP         
Sponsors and Collaborators
Ospedale San Donato
Smith & Nephew, Inc.
Italian Association of Hospital Pneumologists
Investigators
Study Chair: Raffaele Scala, MD, FCCP PULMONARY DIVISION WITH RESPIRATORY INTENSIVE CARE UNIT, S. DONATO HOSPITAL, AREZZO, ITALY
  More Information

Publications:
Responsible Party: Raffaele Scala, MD, Ospedale San Donato
ClinicalTrials.gov Identifier: NCT01351155     History of Changes
Other Study ID Numbers: RSAIPO2011
Study First Received: May 5, 2011
Last Updated: November 30, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by Ospedale San Donato:
acute respiratory failure
noninvasive ventilation

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Adult
Respiratory Insufficiency
Lung Diseases
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 20, 2014