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A Feasibility Study Evaluating the Use of a Non-invasive Ventilation Mask

Not Applicable
Completed
Conditions
Noninvasive Ventilation
Respiratory Insufficiency
Registration Number
NCT02383719
Lead Sponsor
Convergent Engineering, Inc.
Brief Summary

Evaluate the clinicians assessment of the use of an oro-nasal mask during non-invasive ventilation (non-intubated) with a feasibility study.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
18
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Clinician Assessment of Use With a QuestionnaireDuring 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

Secondary Outcome Measures
NameTimeMethod

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