Assessing the DIAphragM Before ANd After Endobronchial Valve Treatment

NCT ID: NCT04735731

Last Updated: 2024-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-28

Study Completion Date

2024-02-13

Brief Summary

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Rationale:

The diaphragm is the principal respiratory muscle, which separates the thorax from the abdomen. Hyperinflation of the lung places the diaphragm at a mechanical disadvantage, shortens its operating length and changes the mechanical arrangement of costal and crural components of the diaphragm and consequently decrease the tension that can be developed and the amount of transdiaphragmatic pressure that can be produced. Reducing the lung hyperinflation could improve the diaphragm function mechanically. One of the treatments to reduces lung hyperinflation is the bronchoscopic treatment using endobronchial valves. To our knowledge the change in diaphragm function after bronchoscopic endobronchial valve treatment was never investigated.

Objective:

To investigate the change in diaphragm function after bronchoscopic lung volume reduction treatment with endobronchial valves (EBV).

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.

Main study parameters: Change in diaphragm function 6 week after EBV treatment measured by ultrasound. The main outcome will be diaphragm motion (difference between maximum in- and expiration).

Detailed Description

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Conditions

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Emphysema

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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EBV-patients

Patients who are scheduled for a bronchoscopic lung volume reduction treatment using endobronchial valves

Echography

Intervention Type DIAGNOSTIC_TEST

Echography of diaphragma and other respiratory muscles

Interventions

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Echography

Echography of diaphragma and other respiratory muscles

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

1. Patient is scheduled for a bronchoscopic lung volume treatment using one-way valves
2. Patient read, understood and signed the Informed Consent Form
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Medical Center Groningen

OTHER

Sponsor Role lead

Responsible Party

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Dirk-Jan Slebos

MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dirk-Jan Slebos, PhD

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Groningen

Locations

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UMCG Groningen

Groningen, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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DIAMANT-study

Identifier Type: -

Identifier Source: org_study_id

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