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

Primary Purpose

Noninvasive Ventilation, Respiratory Insufficiency

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Oro-nasal Mask
Sponsored by
Convergent Engineering, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Noninvasive Ventilation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Oro-nasal mask

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Full Information

    First Posted
    February 27, 2015
    Last Updated
    April 11, 2016
    Sponsor
    Convergent Engineering, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02383719
    Brief Title
    A Feasibility Study Evaluating the Use of a Non-invasive Ventilation Mask
    Acronym
    mask
    Official Title
    Oro-nasal Mask Patient Comfort Evaluation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2015 (undefined)
    Primary Completion Date
    January 2016 (Actual)
    Study Completion Date
    January 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Convergent Engineering, Inc.

    4. Oversight

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Noninvasive Ventilation, Respiratory Insufficiency

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    18 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Oro-nasal mask
    Arm Type
    Experimental
    Arm Description
    All patients are included in this arm. Patients in this group receive the experimental oro-nasal mask during non-invasive ventilation
    Intervention Type
    Device
    Intervention Name(s)
    Oro-nasal Mask
    Primary Outcome Measure Information:
    Title
    Clinician Assessment of Use With a Questionnaire
    Description
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hassan Alnuaimat, M.D.
    Organizational Affiliation
    University of Florida
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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