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NCT02726048 Clinical Trial

Simplus and Eson Non-Invasive Ventilation (NIV) Evaluation - Germany

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:
Simplus and Eson Non-Invasive Ventilation (NIV) Evaluation - Germany

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT02726048
Other study ID # CIA178
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date April 2016
Est. completion date July 2017

Study information
Verified date July 2018
Source Fisher and Paykel Healthcare
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This investigation is designed to evaluate the performance, comfort and ease of use of the Simplus and Eson masks amongst NIV patients who are currently on Bi-level therapy

Description:

Up to 40 NIV patients who currently use a full face mask or a nasal mask will be recruited. They will be issued a Simplus (if they are existing full face users) or Eson (if they are existing nasal users) to use in-home for 2 weeks. This will consists of male and female participants who have been prescribed with NIV therapy for at least 3 months.

Recruitment information / eligibility
Status Terminated
Enrollment 4
Est. completion date July 2017
Est. primary completion date July 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Aged 18+

- Existing full face mask user or a nasal mask user

- Prescribed NIV therapy for at least 3 months

Exclusion Criteria:

- Inability to give informed consent

- Pregnant or think they may be pregnant

- Anatomical or physiological conditions making NIVtherapy inappropriate

- Patients who are in a coma or decreased level of consciousness

- Existing Simplus and Eson users

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Simplus/Eson
Released product Simplus and Eson masks

Locations
Country Name City State
Germany Charité - Universitätsmedizin Berlin Berlin

Sponsors (1)
Lead Sponsor Collaborator
Fisher and Paykel Healthcare

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Objective Leak data Obtained from the participant's device 2 weeks
Secondary Subjective measurement of Leak Questionnaire 2 weeks
Secondary Subjective measurement of Comfort Questionnaire 2 weeks
Secondary Subjective measurement of Ease of Use Questionnaire 2 weeks
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