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

Convergent Engineering

Status: Completed

Conditions: Noninvasive Ventilation; Respiratory Insufficiency

Treatments: Device: Oro-nasal Mask

Study type: Interventional

Funder types: Industry

Identifiers

NCT02383719

Conveng - 002

Details and patient eligibility

About

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

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

Oro-nasal mask

Experimental group

Description:

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

Treatment:

Device: Oro-nasal Mask