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

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

Sponsors

Lead sponsor: Fisher and Paykel Healthcare

Source Fisher and Paykel Healthcare
Brief 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

Detailed 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.

Overall Status Terminated
Start Date April 2016
Completion Date July 2017
Primary Completion Date July 2017
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Objective Leak data 2 weeks
Secondary Outcome
Measure Time Frame
Subjective measurement of Leak 2 weeks
Subjective measurement of Comfort 2 weeks
Subjective measurement of Ease of Use 2 weeks
Enrollment 4
Condition
Intervention

Intervention type: Device

Intervention name: Simplus/Eson

Description: Released product Simplus and Eson masks

Arm group label: Full face/Nasal masks

Eligibility

Criteria:

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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Ingo Fietze, Professor Principal Investigator Charite University, Berlin, Germany
Location
facility
Charité - Universitätsmedizin Berlin
Location Countries

Germany

Verification Date

July 2018

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Arm group label: Full face/Nasal masks

Arm group type: Experimental

Description: Simplus/Eson

Patient Data No
Study Design Info

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov