EMG measurements of respiratory muscles for the titration of nocturnal non-invasive ventilation in stable chronic obstructive pulmonary disease patients; a randomised cross-over trial.

Phase 3

Completed

• Conditions: longemfyseem; 10006436; COPD

• Registration Number: NL-OMON42530
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 12

Inclusion Criteria

- Chronic Obstructive Pulmonary Diseases GOLD stage III or IV (FEV1 < 50% predicted, FEV1/FVC < 70% predicted)
- Indication for the initiation of chronic NIV: PaCO2 > 6.0 kPa at rest during daytime, in stable condition
- Stable COPD (pH < 7,35 and no exacerbation in the past two weeks)
- Age > 18 years

Exclusion Criteria

- Respiratory failure of any other cause, for example concomitant neuromuscular disease.
- Already initiated chronic NIV

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Our primary outcome is nocturnal gas exchange after 6 weeks NIV. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes will be better patient comfort, health-realted quality of<br /><br>life, lung function, and compliance with the ventilator after 6 weeks.<br /><br>Furthermore, patient-ventilator asynchrony will be assessed. </p><br>