Change in Task-related Oxygen Uptake After EBV Treatment

NCT ID: NCT06702072

Last Updated: 2024-11-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2026-08-01

Brief Summary

Rationale: 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). 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. Previously it was found that it was easier for patient to perform these activities after the EBV treatment. However, the physiological load during these ADLs has never been investigated before.

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.

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 population: Patients with emphysema who are scheduled for a bronchoscopic lung volume reduction treatment using endobronchial valves.

Intervention: Not applicable Main study parameters: The change in task-related oxygen uptake measured with a mobile oxygen device during activities of daily life 6 months after EBV treatment.

Detailed Description

Rationale: 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. Previously, it was found that it was easier for patient to perform these activities after the EBV treatment. However, the physiological load during these ADLs was not investigated before. 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.

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 population: Patients with emphysema who are scheduled for a bronchoscopic lung volume reduction treatment using endobronchial valves.

Intervention: Not applicable Main study parameters: The change in task-related oxygen uptake measured with a mobile oxygen device during activities of daily life 6 months after EBV treatment.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: This study has no specific benefits for the participating patients and the study also has no major risks.

Conditions

COPD

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Endobronchial valve treatment

Patients who are undergo a bronchoscopic treatment using endobronchial valves.

Endobronchial valve treatment

Intervention Type: DEVICE

Endobronchial valve treatment

Interventions

Endobronchial valve treatment

Endobronchial valve treatment

Intervention Type: DEVICE

Eligibility Criteria

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) Patients who cannot perform ADL activities without the use of Long Term Oxygen Therapy (LTOT).

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dirk-Jan Slebos

OTHER

Sponsor Role: lead

Responsible Party

Dirk-Jan Slebos

MD PhD

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

University Medical Center Groningen

Groningen, , Netherlands

Countries

Netherlands

Central Contacts

Jorine E Hartman, PhD

Role: CONTACT

j.hartman@umcg.nl

0031503619194

Marlies van DIjk, MD PhD

Role: CONTACT

0031503619194

Facility Contacts

Jorine E. Hartman, PhD

Role: primary

j.hartman@umcg.nl

0031503619194

Other Identifiers

CROCODILE

Identifier Type: -

Identifier Source: org_study_id