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Evaluate the clinicians assessment of the use of an oro-nasal mask during non-invasive ventilation (non-intubated) with a feasibility study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oro-nasal mask | Experimental | All patients are included in this arm. Patients in this group receive the experimental oro-nasal mask during non-invasive ventilation |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oro-nasal Mask | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | During non-invasive ventilation with the oro-nasal mask |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hassan Alnuaimat, M.D. | University of Florida | Principal Investigator |
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Comfort of mask fit for patients receiving non-invasive ventilation at Shands hospital in Gainesville Florida
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| ID | Title | Description |
|---|---|---|
| FG000 | Oro-nasal Mask | Oro-nasal Mask |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Oro-nasal Mask | Oro-nasal Mask |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Median | Inter-Quartile Range | units on a scale | During non-invasive ventilation with the oro-nasal mask |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Oro-nasal Mask | Oro-nasal Mask |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Coordinator | Convergent Engineering | 3523784899 | 113 | carl@conveng.com |
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| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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All patients in this group received the experimental oro-nasal mask for evaluation of use. Patient's received non-invasive ventilation were switched to this mask upone study initiation.
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| 0 |
| 18 |
| 0 |
| 18 |
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