Impact of Noninvasive With Expiratory Washout on Respiratory Rate of Patients With Acute Hypercapnic Respiratory Failure

Study Overview
=================
Brief Summary
-----------------
This study will determine if NIV using the Vela investigational mask with expiratory washout of the upper airway more effectively reduces respiratory rate in acute patients with hypercapnic respiratory failure. Patients admitted to hospital with acute respiratory failure (ARF) will be assessed for hypercapnic ARF by normal hospital protocols. Patients requiring noninvasive ventilation (NIV) will be set up on NIV as prescribed per standard of care. Enrollment onto the investigation will occur after the patient has been allowed to stabilize on NIV . Patients that meet the inclusion/exclusion criteria will be approached for consent. Investigation participants will receive two masks in random order; NIV for one hour with the investigational mask (Vela) NIV for one hour with the standard mask (Nivairo). Participants will have their physiological respiratory parameters recorded.

Detailed Description
-----------------
This is a simple study. Patients who are already on noninvasive ventilation (NIV) for acute respiratory failure will be approached for the study within the first 24 hours on NIV therapy. The study will be conducted as described above. After the study patients will be able to choose which mask they continue their NIV on. They will continue NIV as part of their normal hospital care.

Official Title
-----------------
Evaluate the Impact of Noninvasive (NIV) With Expiratory Washout on Respiratory Rate of Patients With Acute Hypercapnic Respiratory Failure. A Prospective, Randomized Cross Over Pilot Investigation.

Conditions
-----------------
Noninvasive Ventilation

Intervention / Treatment
-----------------
* Device: Vela Investigational Mask
* Device: Nivairo Standard Mask


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have type II acute respiratory failure (ARF) and have been prescribed NIV Arterial blood gas (ABG) Partial pressure of arterial carbon dioxide greater or equal to 6.0 kilopascals (45 millimeters of mercury) Arterial blood gas acidity greater or equal to 7.35 prior to bilevel commencement On NIV for 24 hours or less Negative Covid-19 test Are 18 years or older Exclusion Criteria: Contraindicated for NIV On NIV in Emergency Department/ ward for more than 24 hours, within the last 48 hours NIV is likely to fail and/or intubation be required, at the doctor's discretion CPAP or bilevel pressure of 25 centimeters of water or more is required Unable to tolerate NIV for the duration of the investigation Do not fit the investigational mask or the standard mask Pregnancy (tested under standard care) Agitated Unable to understand the consent process

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Crossover study where each participant receives NIV on the Vela investigational mask and the Nivairo standard mask for one hour each in random order.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Noninvasive ventilation (CPAP or bilevel) with the Vela investigational mask for 1 hour<br>Pressure settings for noninvasive ventilation to be set as required to provide optimal respiratory support for each patient. Not to be changed during the 2 hours of the study. | Device: Vela Investigational Mask<br>* Wear mask to enable the delivery of noninvasive ventilation (CPAP or bilevel) therapy.<br>|
| Active Comparator: Noninvasive ventilation (CPAP or bilevel) with the standard mask (Nivairo) for 1 hour<br>Pressure settings for noninvasive ventilation to be set as required to provide optimal respiratory support for each patient. Not to be changed during the 2 hours of the study. | Device: Nivairo Standard Mask<br>* Wear mask to enable the delivery of noninvasive ventilation (CPAP or bilevel) therapy.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in respiratory rate | The change in patient's respiratory rate over the 1 hour of the study arm | 1 hour |