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

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.

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;

1. NIV for one hour with the investigational mask (Vela)
2. NIV for one hour with the standard mask (Nivairo).

Participants will have their physiological respiratory parameters recorded.

Study Overview

• Status: Not yet recruiting
• Conditions: Noninvasive Ventilation
• Intervention / Treatment: Device: Vela Investigational Mask; Device: Nivairo Standard Mask

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Noninvasive ventilation (CPAP or bilevel) with the Vela investigational mask for 1 hour; 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; Wear mask to enable the delivery of noninvasive ventilation (CPAP or bilevel) therapy.
Active Comparator: Noninvasive ventilation (CPAP or bilevel) with the standard mask (Nivairo) for 1 hour; 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; Wear mask to enable the delivery of noninvasive ventilation (CPAP or bilevel) therapy.

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

Collaborators and Investigators

• Sponsor: Fisher and Paykel Healthcare

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2023
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: July 11, 2023
• First Submitted That Met QC Criteria: July 26, 2023
• First Posted (Actual): July 27, 2023

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 26, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: FisherPaykel

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No IPD will be shared with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No