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NCT02383719 Clinical Trial

Mask Comfort Feasibility

Respiratory Insufficiency Clinical Trial

— mask  

Official title:
Oro-nasal Mask Patient Comfort Evaluation

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT02383719
Other study ID # Conveng - 002
Secondary ID
Status Not yet recruiting
Phase N/A
First received February 27, 2015
Last updated March 3, 2015
Start date March 2015

Study information
Verified date March 2015
Source Convergent Engineering, Inc.
Contact Carl Tams, B.S.
Phone 3525147459
Email carl@conveng.com
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 100
Est. completion date
Est. primary completion date January 2017
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Intervention

Device:
• Oro-nasal Mask

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Convergent Engineering, Inc.

Outcome
Type Measure Description Time frame Safety issue
Primary Clinician assessment of patient comfort with a comfort questionnaire During non-invasive ventilation No
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