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

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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Key information

Conditions

Noninvasive Ventilation Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oro-nasal Mask

Device

Primary outcomes

Clinician Assessment of Use With a Questionnaire

Time frame: 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

Sponsors and collaborators

Lead sponsor

Convergent Engineering, Inc.

Industry

Registry information

Official study title

Oro-nasal Mask Patient Comfort Evaluation

Acronym: mask

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: Mar 9, 2015
Registry last updated: May 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed