Acute Respiratory Insufficiency
Conditions
Keywords
acute respiratory insufficiency, noninvasive ventilation, oronasal face mask, total face mask
Brief summary
The purpose of this study is to compare the Total Face Mask™ (Respironics, Inc., Pittsburgh, PA) (covering whole face) and the standard oronasal facemask (covering nose and mouth) for the emergency treatment of patients with acute respiratory failure with the machine blowing air into the mask placed on the face (noninvasive positive pressure ventilation) (NPPV).
Detailed description
Despite its demonstrated efficacy in treating selected patients with acute respiratory failure, the application of NPPV is still plagued by a substantial failure rate, ranging from below 10% to above 40%. Mask intolerance ranks as one of the most common causes of failure. This is related to ill-fitting masks, mask discomfort (despite a properly fitted mask), excessively tightened straps, excessive air leaks around the mask or through the mouth, and claustrophobia. The most commonly used masks in the acute care setting are either oronasal masks that cover the nose and mouth, or nasal masks that cover the nose alone. Both mask types usually consist of clear plastic dome-shaped mask with a soft silicon gasket to create an air seal with the skin. While this approach is usually successful, it may lead to patient discomfort and/or an air leak secondary to the difficulty in creating an effective seal over the bridge of the nose and over mobile structures such as the mandible. The Total Face Mask ™ (Respironics, Inc., Pittsburgh, PA) uses a different approach to avoid some of these limitations. Considerably larger than a standard oronasal mask, it covers the entire face and creates an air seal using a silicon gasket around the parameter of the face. In this way, gasket pressure is more evenly distributed, and discomfort over the bridge of the nose or chin is eliminated, and air leaking reduced. In addition, because one mask size fits virtually all patients, the Total Face Mask ™ facilitates the fitting process and permits more rapid initiation of ventilatory assistance. Clinical experience to date suggests that claustrophobia is not a common problem with the Total Face Mask ™ despite its size, and that its contribution to dead space is comparable to that of most oronasal masks. The following protocol aims to compare use of the Total Face Mask ™ to the Comfort Full oronasal mask (also by Respironics, Inc., Pittsburgh, PA)or RT040 oronasal mask (Fisher&Paykel Inc., Wellington, NZ) in the acute care setting for patients meeting standard indications for NPPV.
Interventions
DEVICETotal face mask (interface for NPPV)
NPPV is applied by this mask, as long as NPPV is received.
DEVICEComfort full or RT040 oronasal mask (interface for NPPV)
NPPV is applied by one of these masks (Comfort full or RT040 masks used at Rhode Island Hospital and Tufts Medical Center respectively), as long as NPPV is received.
Sponsors
Rhode Island Hospital
Tufts Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age\>18 * Either A or B A. Clinical Criteria: Moderate to severe respiratory distress as evidenced by tachypnea, use of accessory muscles for breathing, or abdominal paradox. B. Blood Gas and Physiologic Criteria: Gas exchange abnormalities including PaCO2\>45 with a pH\<7.35, or a PaO2/FiO2 ratio\<200.
Exclusion criteria
* The need for immediate intubation * Medical instability such as hypotensive shock, uncontrolled cardiac ischemia or arrythmias, unstable myocardial infarction, uncontrolled upper gastrointestinal bleeding * Agitation or uncooperativeness, unresponsive to small doses of sedatives * Excretions or inability to protect the airway * Inability to fit the mask * Facial trauma * Upper airway obstruction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mask Comfort (as Determined by the Visual Analog Scores 1 Being Least, 10 Being Most) | During the first 3 hours of recruitment |
| Time Required for Mask Placement | at the initiation of NPPV |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Deterioration in Gas Exchange | during the first 24 hours of the study | — |
| Total Length of Time Requiring NIV | during hospitalization (after recruitment) | — |
| Early NIV Discontinuation Rate | During hospitalization period (after recruitment into the study) | Defined as the inability of the patient to be maintained on NPPV using the assigned mask while there was still an indication for ventilatory support |
| In-hospital Mortality Rate | during hospitalization (after recruitment) | — |
| Length of Hospital Stay | during hospitalization (after recruitment) | — |
| Deterioration Vital Signs | during the first 24 hours of the study | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Total Face Mask Patients receiving NPPV by the 'Total Face Mask' or standard face mask controls | 29 |
| Standard Face Mask Controls Patients receiving NPPV by 'standard oronasal mask' | 31 |
| Total | 60 |
Baseline characteristics
| Characteristic | Total Face Mask | Standard Face Mask Controls | Total |
|---|---|---|---|
| Age, Continuous | 63.4 years STANDARD_DEVIATION 15 | 62.6 years STANDARD_DEVIATION 17 | 62.9 years STANDARD_DEVIATION 9 |
| Region of Enrollment United States | 29 participants | 31 participants | 60 participants |
| Sex: Female, Male Female | 14 Participants | 17 Participants | 31 Participants |
| Sex: Female, Male Male | 15 Participants | 14 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 6 / 29 | 4 / 31 |
| serious Total, serious adverse events | 0 / 29 | 0 / 31 |
Outcome results
Primary
Mask Comfort (as Determined by the Visual Analog Scores 1 Being Least, 10 Being Most)
Time frame: During the first 3 hours of recruitment
Population: By power analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Mask Comfort (as Determined by the Visual Analog Scores 1 Being Least, 10 Being Most) | 3.2 units on a scale | Standard Error 0.6 |
| Total Face Mask | Mask Comfort (as Determined by the Visual Analog Scores 1 Being Least, 10 Being Most) | 3.3 units on a scale | Standard Error 0.7 |
Primary
Time Required for Mask Placement
Time frame: at the initiation of NPPV
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control | Time Required for Mask Placement | 5 Minutes |
| Total Face Mask | Time Required for Mask Placement | 3.5 Minutes |
Secondary
Deterioration in Gas Exchange
Time frame: during the first 24 hours of the study
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Deterioration in Gas Exchange | 3 Participants |
| Total Face Mask | Deterioration in Gas Exchange | 3 Participants |
Secondary
Deterioration Vital Signs
Time frame: during the first 24 hours of the study
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Deterioration Vital Signs | 7 Participants |
| Total Face Mask | Deterioration Vital Signs | 3 Participants |
Secondary
Early NIV Discontinuation Rate
Defined as the inability of the patient to be maintained on NPPV using the assigned mask while there was still an indication for ventilatory support
Time frame: During hospitalization period (after recruitment into the study)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Early NIV Discontinuation Rate | 12 Participants |
| Total Face Mask | Early NIV Discontinuation Rate | 16 Participants |
Secondary
In-hospital Mortality Rate
Time frame: during hospitalization (after recruitment)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | In-hospital Mortality Rate | 6 Participants |
| Total Face Mask | In-hospital Mortality Rate | 3 Participants |
Secondary
Length of Hospital Stay
Time frame: during hospitalization (after recruitment)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Control | Length of Hospital Stay | 19.2 Days |
| Total Face Mask | Length of Hospital Stay | 10.9 Days |
Secondary
Total Length of Time Requiring NIV
Time frame: during hospitalization (after recruitment)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control | Total Length of Time Requiring NIV | 15.7 Hours |
| Total Face Mask | Total Length of Time Requiring NIV | 6.05 Hours |