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

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.

Study Overview

• Status: Unknown
• Conditions: Acute Respiratory Failure
• Intervention / Treatment: Device: Skin protective dressing device

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 Type: Interventional
• Enrollment (Anticipated): 252
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Lucca, Italy, 55100
    • Recruiting
    • Pulmonary Division With Respiratory Intensive Care Unit, S. Donato Hospital, Arezzo, Italy
    • Contact: Email: raffaele_scala@hotmail.com
    • Principal Investigator: Raffaele Scala, MD, FCCP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Failure rate of the prevention of the facial mask ventilation-induced skin damage in the three interventional groups and in the control group	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mask-induced discomfort	Discomfort/pain consequent to NIV-induced skin damage with the different protective devices	7 days
Costs for skin protection	Amounts of costs due to prevention of NIV-induced skin damage with the different protective devices	7 days
Prediction of NIV-induced skin damage	Identification of the variables independently associated with the development of skin injury due to mask ventilation	7 days
Success of NIV	Rate of success of NIV to avoid endotracheal intubation and death	Up to 30 days

Collaborators and Investigators

• Sponsor: Ospedale San Donato
• Collaborators: 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

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Anticipated): May 1, 2015
• Study Completion (Anticipated): October 1, 2015

Study Registration Dates

• First Submitted: May 5, 2011
• First Submitted That Met QC Criteria: May 9, 2011
• First Posted (Estimate): May 10, 2011

Study Record Updates

• Last Update Posted (Estimate): December 31, 2014
• Last Update Submitted That Met QC Criteria: December 29, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: noninvasive ventilation; acute respiratory failure
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Respiratory Insufficiency; Respiratory Distress Syndrome
• Other Study ID Numbers: RSAIPO2011