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

Not Applicable

Not yet recruiting

• Conditions: Noninvasive Ventilation
• Interventions: Device: Vela Investigational Mask; Device: Nivairo Standard Mask

• Registration Number: NCT05964244
• Lead Sponsor: Fisher and Paykel Healthcare

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;

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.

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 Timeline

• Status Verified: 2023-07
• Study First Submitted: 2023-07-11
• Study First Submitted QC: 2023-07-26
• Last Update Submitted: 2023-07-26
• Study First Posted: 2023-07-27
• Last Update Posted: 2023-07-27
• Study Start: 2023-11
• Primary Completion: 2024-05
• Study Completion: 2024-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Noninvasive ventilation (CPAP or bilevel) with the Vela investigational mask for 1 hour	Vela Investigational Mask	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.
Noninvasive ventilation (CPAP or bilevel) with the standard mask (Nivairo) for 1 hour	Nivairo Standard Mask	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.

Primary Outcome Measures

Name	Time	Method
Change in respiratory rate	1 hour	The change in patient's respiratory rate over the 1 hour of the study arm