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

Not Applicable

Completed

• Conditions: Noninvasive Ventilation; Respiratory Insufficiency
• Interventions: Device: Oro-nasal Mask

• 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

Study Timeline

• Study First Submitted: 2015-02-27
• Study Start: 2015-03
• Study First Submitted QC: 2015-03-03
• Study First Posted: 2015-03-09
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Results First Submitted: 2016-01-13
• Status Verified: 2016-04
• Results First Submitted QC: 2016-04-11
• Last Update Submitted: 2016-04-11
• Results First Posted: 2016-05-16
• Last Update Posted: 2016-05-16

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

Arm && Interventions

Group	Intervention	Description
Oro-nasal mask	Oro-nasal Mask	All patients are included in this arm. Patients in this group receive the experimental oro-nasal mask during non-invasive ventilation

Primary Outcome Measures

Name	Time	Method
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