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

Convergent Engineering, Inc.18 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Noninvasive Ventilation Respiratory Insufficiency

Interventions

Oro-nasal MaskDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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