A study to investigate the effect of a new nasal mask on breathing and comfort while using non-invasive ventilation in adults with chronic respiratory failure.

Not Applicable

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

• Registration Number: ACTRN12623000926639
• Lead Sponsor: Fisher & Paykel Healthcare Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-08-29
• Last Update Posted: 13 November 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

A doctor’s diagnosis of a chronic respiratory and/or cardiovascular disease
AND
Oxygen saturation measured by pulse oximetry (SpO2) of less than or equal to 90% while breathing room air
OR
PtcCO2 greater than or equal to 45mmHg on transcutaneous monitor at baseline measurement

Exclusion Criteria

•Age < 18 years
•Unable to tolerate oxygen saturations on room air if on long term oxygen therapy
•Evidence of respiratory infection or colonization with multidrug resistant bacteria, Pseudomonas species, Burkholderia Cepacia or mycobacteria
•Suspected or proven infection with SARS-CoV-2 (COVID-19)
•Risk of barotrauma, as assessed by the investigator
•Nasal or facial conditions precluding use of NIV with nasal pillow or oronasal mask
•Failure of mask fitting test
•Intracranial trauma or trans-nasal neurosurgery (within 6 weeks)
•Failure of PulmoVista 500 IET electrode belt fitting (low signal quality, poor skin integrity)
•BMI >50
•Weight <50kg
•Cardiac pacemaker, an implantable cardioverter-defibrillator (ICD) or any other active implants
•Self-reported current pregnancy
•Any other condition which, at the investigator’s discretion, is believed may present a safety risk or impact the feasibility of the study or the study results

Study & Design

• Study Type: Interventional
• Study Design: Not specified