To investigate the change in exercise physiology during daily activities after EBV treatment.
ID
Source
Brief title
Condition
- Respiratory disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The change in task-related oxygen uptake measured with a mobile oxygen device
during activities of daily life 6 months after EBV treatment.
Secondary outcome
To investigate the change between baseline and 6 months of follow-up after EBV
treatment in:
- task completion time.
- ventilation during rest.
- ventilation during activities of daily life.
- dyspnoea sensation during activities of daily life
- oxygen saturation during activities of daily life
- diaphragmatic neuromechanical coupling during rest and activities of daily
life
- dynamic hyperinflation during activities of daily life
- oxygen pulse during activities of daily life.
- ventilatory efficiency during activities of daily life
Background summary
Bronchoscopic lung volume reduction using endobronchial valves (EBV) has
emerged as a viable treatment option for eligible patients with severe
emphysema. In all studies conducted so far, exercise capacity has only been
measured using the 6-minute walk distance test (6MWT). The 6MWT is conducted
under laboratory conditions, which weakly correspond to activities of daily
living (ADL). It is known that patients with COPD frequently experience
problems during ADL, which can lead to avoidance of or care dependency for
performing certain tasks and have a significant social impact on their lives.
Patients report that it is easier to perform ADLs after EBV treatment. We also
found that it was easier for patient to perform these activities after the EBV
treatment. However, we did not investigate the physiological load during these
ADLs. This could be measured with a mobile oxygen device which can measure
oxygen uptake (VO2) and carbon dioxide production (VCO2) under more functional
conditions and thus measure the metabolic load of these activities.
Potentially, EBV treatment could improve the metabolic load and consequently
symptom perception, thus enhancing the execution of ADLs, which is an important
patient-centred outcome. However, this has not been investigated so far.
Study objective
To investigate the change in exercise physiology during daily activities after
EBV treatment.
Study design
Observational study in which the study population will be asked to perform some
additional test during regular visits for the bronchoscopic lung volume
reduction treatment with valves.
Study burden and risks
This study has no specific benefits for the participating patients and the
study also has no major risks.
Hanzeplein 1
Groningen 9713GZ
NL
Hanzeplein 1
Groningen 9713GZ
NL
Listed location countries
Age
Inclusion criteria
1) Patient is scheduled for a bronchoscopic lung volume treatment using Pulmonx
Zephyr
Endobronchial Valves;
2) Patient read, understood and signed the Informed Consent Form.
Exclusion criteria
1) De patiënt staat gepland voor een bronchoscopische longvolumebehandeling met
behulp van Pulmonx Zephyr endobronchiale kleppen.
2) De patiënt heeft het toestemmingsformulier gelezen, begrepen en ondertekend.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT06702072 |
| CCMO | NL88372.042.24 |