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

• Sponsor: Fisher and Paykel Healthcare (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05964244
• Collaborator: (none)
• Enrollment: 20
• Arms: 2
• Anticipated Duration (Months): 6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Noninvasive Ventilation	Device: Vela Investigational Mask; Device: Nivairo Standard Mask	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention 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.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 (Outcomes Assessor)
• Masking Description: NIV masks can not be masked during the treatments. Only the analysis will be masked.
• Primary Purpose: Treatment
• 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.
• Anticipated Study Start Date: Nov 1, 2023
• Anticipated Primary Completion Date: May 1, 2024
• Anticipated Study Completion Date: May 1, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Change in respiratory rate [1 hour]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Fisher and Paykel Healthcare

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fisher and Paykel Healthcare
• ClinicalTrials.gov Identifier: NCT05964244
• Other Study ID Numbers: FisherPaykel
• First Posted: Jul 27, 2023
• Last Update Posted: Jul 27, 2023
• Last Verified: Jul 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Respiratory Insufficiency

Study Results

No Results Posted as of Jul 27, 2023