NIV With Airway Washout for Dual Limb Ventilation: Improvement in Minute Ventilation

NCT06939920 | Not Yet Recruiting

• 1 other identifier: Fisher and Paykel Healthcare
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a prospective, non-randomized, non-blinded, crossover feasibility investigation to assess the safety, usability, and efficacy of the investigational mask in the hospital environment. Eligible patients that are stable in NIV and able to give informed consent will be approached and if they consent the patient will be included in the study. If potential participants decline, normal hospital care will be continued. The enrolled participant will receive NIV on the commercially available Visairo mask for one hour during which their ventilatory parameters will be logged. Then the participant will be switched to the investigational mask for another hour. The ventilator data will be collected for these two hours. At the end of the intervention the participant will be reverted to their original mask. The medical staff will be asked to fill out the case report form pertaining to the function and usability of the investigational mask compared to the conventional mask.

Conditions

Respiratory Failure Requiring Non Invasive Ventilation

Keywords

Non-invasive ventilation; OptiNIV; Airway washout

Outcome Measures

Primary Outcomes (1)

• minute ventilation

  To establish that the performance of the investigational mask is on par or better than a conventional NIV. Comparing the Visairo and the investigational masks for a reduction in minute ventilation over the 1 hour study period. We anticipate a reduction in minute ventilation that is 2L/min less than in the comparator mask. This will be established with a paired T test over the first 5 and last 5 min of data extracted from the ventilator.

  The first 5 minutes on each mask will be compared to the last 5 minutes on the same mask and the differences compared by paired T-test.

Secondary Outcomes (5)

• Ventilator data (pressure)

  Ventilator data can be logged in 5 min intervals the study data ie 1h on visairo and 1h on optiniv dual will be exported to USB after the participant has concluded both arms.

• Ventilator data (flow)

  Ventilator data can be logged in 5 min intervals the study data ie 1h on visairo and 1h on optiniv dual will be exported to USB after the participant has concluded both arms.

• user feedback

  once both arms are completed, right after the 2 hours on NIV

• Ventilator data (leak)

  Ventilator data can be logged in 5 min intervals the study data ie 1h on visairo and 1h on optiniv dual will be exported to USB after the participant has concluded both arms.

• Ventilator data (alarms)

  Ventilator data can be logged in 5 min intervals the study data ie 1h on visairo and 1h on optiniv dual will be exported to USB after the participant has concluded both arms.

Study Arms (2)

Visairo

ACTIVE COMPARATOR

Visairo is a commercially available sub nasal oronasal mask that has a similar design as the interventional OptiNIV Dual Mask

Other: non-invasive ventilation

OptiNIV Dual

EXPERIMENTAL

Like the commercially available OptiNIV mask, this mask provides NIV with airway washout but now for dual limb ventilators.

Other: Non-invasive ventilation mask with airway washout

Interventions

Non-invasive ventilation mask with airway washout OTHER

Non-invasive ventilation mask with airway washout for dual limb ventilators

OptiNIV Dual

non-invasive ventilation OTHER

standard state of the art non-invasive ventilation

Visairo

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults admitted to the ICU prescribed NIV and stable
• Able to receive therapy on a sub-nasal (under-the-nose) mask
• Are 18 years old or older

You may not qualify if:

• Contraindicated for NIV
• NIV is likely to fail and/or intubation be required, at the medical staff's discretion
• Bilevel pressure of ≥ 30 cmH2O required
• Do not fit the investigational mask or the standard mask
• Pregnancy (tested under standard care)
• Unable to tolerate NIV for the duration of the investigation
• Agitated
• Unable to understand the consent process

Sponsors & Collaborators

• Fisher and Paykel Healthcare: lead

MeSH Terms

Interventions

Noninvasive Ventilation

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: prospective, non-randomized, non-blinded, crossover pilot investigation

Study Record Dates

• First Submitted: March 31, 2025
• First Posted: April 23, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: May 22, 2025

Record last verified: 2025-05