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NCT Number: NCT06702072

Change in Task-related Oxygen Uptake After EBV Treatment

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Center Groningen

Groningen, 9713 GZ, Netherlands

Location status: Recruiting

Location contact

Jorine E. Hartman, PhD

CONTACT

[email protected]

0031503619194

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient is scheduled for a bronchoscopic lung volume treatment using Pulmonx Zephyr Endobronchial Valves;
  • Patient read, understood and signed the Informed Consent Form.

Exclusion criteria

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

Treatment and study plan

Endobronchial valve treatment

Device

Endobronchial valve treatment

Primary outcomes

  1. Task-related oxygen uptake

    Time frame: 6 months follow up

    The change between baseline and 6 months of follow up after EBV treatment in task-related oxygen uptake (VO2) during a set-up daily life activity trail.

Study contacts

Contact information is provided by the study sponsor or research team.

Jorine E Hartman, PhD

CONTACT

[email protected]

0031503619194

Marlies van DIjk, MD PhD

CONTACT

0031503619194

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Official study title

Change in Task-related Oxygen Uptake After Bronchoscopic Lung Volume Reduction With Endobronchial Valves

Acronym: CROCODILE

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Nov 22, 2024
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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