Noninvasive Ventilation, Respiratory Insufficiency
Conditions
Brief summary
Evaluate the clinicians assessment of the use of an oro-nasal mask during non-invasive ventilation (non-intubated) with a feasibility study.
Interventions
DEVICEOro-nasal Mask
Sponsors
Convergent Engineering, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patient requiring non-invasive ventilation in an intensive care unit
Exclusion criteria
* patient not stable for non-invasive ventilation * patient with unprotected airway * excessive secretions * patient with facial surgery * agitated patient
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinician Assessment of Use With a Questionnaire | During non-invasive ventilation with the oro-nasal mask | With the questionnaire we desired to discern the clinicians perception of use of the experimental oro-nasal mask. The questionnaire featured the ease of installation, the ease of use, and the perceived comfort of the patient. Each of the scores were on a scale from 1-5 and each were recorded to be used for individual assessment. Thus each patient has multiple assessment scores individually reported as outcomes. The clinicians were asked on a scale of 1-5 please rate their agreement with the statements The mask was easy to use. 1 strongly disagree, 2 somewhat disagree, 3 neutral, 4 somewhat agree, 5 strongly agree Your perception of patient comfort was acceptable. 1 strongly disagree, 2 somewhat disagree, 3 neutral, 4 somewhat agree, 5 strongly agree |
Participant flow
Recruitment details
Comfort of mask fit for patients receiving non-invasive ventilation at Shands hospital in Gainesville Florida
Participants by arm
| Arm | Count |
|---|---|
| Oro-nasal Mask Oro-nasal Mask | 18 |
| Total | 18 |
Baseline characteristics
| Characteristic | Oro-nasal Mask |
|---|---|
| Age, Continuous | 62 years STANDARD_DEVIATION 11 |
| Region of Enrollment United States | 18 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 18 |
| serious Total, serious adverse events | 0 / 18 |
Outcome results
Primary
Clinician Assessment of Use With a Questionnaire
With the questionnaire we desired to discern the clinicians perception of use of the experimental oro-nasal mask. The questionnaire featured the ease of installation, the ease of use, and the perceived comfort of the patient. Each of the scores were on a scale from 1-5 and each were recorded to be used for individual assessment. Thus each patient has multiple assessment scores individually reported as outcomes. The clinicians were asked on a scale of 1-5 please rate their agreement with the statements The mask was easy to use. 1 strongly disagree, 2 somewhat disagree, 3 neutral, 4 somewhat agree, 5 strongly agree Your perception of patient comfort was acceptable. 1 strongly disagree, 2 somewhat disagree, 3 neutral, 4 somewhat agree, 5 strongly agree
Time frame: During non-invasive ventilation with the oro-nasal mask
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Oro-nasal Mask | Clinician Assessment of Use With a Questionnaire | Ease of Use | 5 units on a scale |
| Oro-nasal Mask | Clinician Assessment of Use With a Questionnaire | Patient Comfort | 4 units on a scale |