What is the effect of wearing a surgical mask or an N95 mask on patients with stable chronic hypercapnic respiratory failure currently using non-invasive ventilation? A randomised cross-over trial

Not Applicable

Completed

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

• Registration Number: ACTRN12623001120662
• Lead Sponsor: Royal Prince Alfred Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-27
• Study Completion: 2024-07-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1.Patients established on non-invasive ventilation (NIV) for the treatment of chronic hypercapnia for at least 28 days
2.Aged 18 years or over
3.Clinically stable (no change to respiratory medications in past 28 days) at the time of randomisation.

Exclusion Criteria

1.Long-term oxygen therapy prescription with use during wakefulness.
2.NIV usage > 16 hrs / day
3.Normal lung function on spirometry
4.Unable to tolerate a surgical mask or N95 mask for more than 1 minute
5.Current inpatient
6.Current infection treated with antibiotics
7.Unable to provide consent due to significant mental health issues.
8. Patients who are unable to understand written or spoken English

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Oxygen saturation measured by a Pulse oximeter [ baseline and at 5 minute intervals for during each 20mins experimental arm, with the primary timepoint at 20 mins post commencement];Transcutaneous carbon dioxide measured by a Sentec Device[ baseline and at 5 minute intervals for during each 20mins experimental arm, with the primary timepoint at 20 mins post commencement]

Secondary Outcome Measures

Name	Time	Method
Breathing discomfort using the A1 scale from the Multidimensional Dyspnea Profile[ Baseline and the end of each experimental arm (20mins)];Heart Rate measured by pulse oximeter [ baseline and at 5 minute intervals for during each 20mins experimental arm ];Respiratory Rate measured by respiratory bands using Alice sleep system.[ baseline and at 5 minute intervals for during each 20mins experimental arm, with the primary timepoint at 20 mins post commencement];breathlessness as measured by Modified Borg Dyspnoea Scale[ baseline and at 5 minute intervals for during each 20mins experimental arm, with the primary timepoint at 20 mins post commencement]