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

Fisher & Paykel Healthcare

Status: Not yet enrolling

Conditions: Noninvasive Ventilation

Treatments: Device: Vela Investigational Mask; Device: Nivairo Standard Mask

Study type: Interventional

Funder types: Industry

Identifiers

NCT05964244

FisherPaykel

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

20 participants in 2 patient groups

Noninvasive ventilation (CPAP or bilevel) with the Vela investigational mask for 1 hour

Experimental group

Description:

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.

Treatment:

Device: Vela Investigational Mask

Noninvasive ventilation (CPAP or bilevel) with the standard mask (Nivairo) for 1 hour

Active Comparator group

Description:

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.

Treatment:

Device: Nivairo Standard Mask