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

NCT02383719 | Completed Results

• 1 other identifier: Conveng - 002
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Noninvasive Ventilation; Respiratory Insufficiency

Outcome Measures

Primary Outcomes (1)

• 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

  During non-invasive ventilation with the oro-nasal mask

Study Arms (1)

Oro-nasal mask

EXPERIMENTAL

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

Device: Oro-nasal Mask

Interventions

Oro-nasal Mask DEVICE

Oro-nasal mask

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patient requiring non-invasive ventilation in an intensive care unit

You may not qualify if:

• patient not stable for non-invasive ventilation
• patient with unprotected airway
• excessive secretions
• patient with facial surgery
• agitated patient

Sponsors & Collaborators

• Convergent Engineering, Inc.: lead

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Results Point of Contact

• Title: Study Coordinator
• Organization: Convergent Engineering

carl@conveng.com

3523784899

Study Officials

• Hassan Alnuaimat, M.D.

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2015
• First Posted: March 9, 2015
• Study Start: March 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: May 16, 2016
• Results First Posted: May 16, 2016

Record last verified: 2016-04