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

NCT05964244 | Unknown

• 1 other identifier: FisherPaykel
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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

Conditions

Noninvasive Ventilation

Outcome Measures

Primary Outcomes (1)

• Change in respiratory rate

  The change in patient's respiratory rate over the 1 hour of the study arm

  1 hour

Study Arms (2)

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

EXPERIMENTAL

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

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

ACTIVE COMPARATOR

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

Interventions

Vela Investigational Mask DEVICE

Wear mask to enable the delivery of noninvasive ventilation (CPAP or bilevel) therapy.

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

Nivairo Standard Mask DEVICE

Wear mask to enable the delivery of noninvasive ventilation (CPAP or bilevel) therapy.

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

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fisher and Paykel Healthcare: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: NIV masks can not be masked during the treatments. Only the analysis will be masked.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Crossover study where each participant receives NIV on the Vela investigational mask and the Nivairo standard mask for one hour each in random order.

Study Record Dates

• First Submitted: July 11, 2023
• First Posted: July 27, 2023
• Study Start: November 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share