A randomised, cross over, non-inferiority trial comparing a newly engineered non-invasive ventilator to a commercially available device in patients with respiratory failure

Not Applicable

Recruiting

• Conditions: Respiratory failure; Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12622001296729
• Lead Sponsor: Fisher and Paykel Healthcare

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-10-06
• Last Update Posted: 20 November 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

• Hospitalised patient currently receiving care in a high dependency unit, respiratory ward or medical ward
• Has received acute NIV therapy for at least 1 hour during their hospital admission.
• No longer dependent on continuous NIV therapy (i.e. able to tolerate at least 3 hours without NIV therapy)
• Had an appropriate indication for commencing acute NIV therapy as assessed by the study investigator
• Spontaneously breathing

Exclusion Criteria

•Any contraindication to NIV therapy (according to use instructions: UI-900887 – AirSpiral NIV tube and chamber kit)
- Cardiac or respiratory arrest, or severe hemodynamic instability
- Unconscious, unable to breathe spontaneously, uncooperative, unresponsive or unable to remove the mask
- Upper airway obstruction, or inability to clear secretions (impaired cough or swallow reflexes, excessive reflux, epistaxis, hiatal hernia)
- Have copious secretions, at risk of nausea/vomiting, or at high risk of aspiration emesis
- Head or facial surgery, trauma, or burns
- Severe upper gastrointestinal bleeding, or barotrauma (undrained pneumothorax)
•Pregnancy
•Any other condition which, at the investigators discretion, is believed may present a safety risk, or impact the feasibility of the study or study results
•Requires ventilatory assistance for life support

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean transcutaneous CO2 (PtCO2) measured using capnography compared between the two devices.[ The transcutaneous partial pressure of carbon dioxide (PtCO2) will be monitored continuously using capnography throughout the trial. End of treatment PtCO2 will be determined as the average of the final 5 minutes of the treatment period and will be adjusted for baseline, which will be determined as the 5-minute average preceding the treatment period.]