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

NCT ID: NCT02383719

Last Updated: 2016-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2016-01-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Oro-nasal mask

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

Group Type: EXPERIMENTAL

Oro-nasal Mask

Intervention Type: DEVICE

Interventions

Oro-nasal Mask

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Convergent Engineering, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hassan Alnuaimat, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Other Identifiers

Conveng - 002

Identifier Type: -

Identifier Source: org_study_id