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Assessing the DIAphragM Before ANd After Endobronchial Valve Treatment (DIAMANT)

U

University Medical Center Groningen (UMCG)

Status

Completed

Conditions

Emphysema

Treatments

Diagnostic Test: Echography

Study type

Observational

Funder types

Other

Identifiers

NCT04735731
DIAMANT-study

Details and patient eligibility

About

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).

Enrollment

25 patients

Sex

All

Volunteers

No Healthy Volunteers

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

Exclusion criteria

There are no exclusion criteria for this study.

Trial design

25 participants in 1 patient group

EBV-patients
Description:
Patients who are scheduled for a bronchoscopic lung volume reduction treatment using endobronchial valves
Treatment:
Diagnostic Test: Echography

Trial contacts and locations

1

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Central trial contact

Jorine Hartman, PhD

Data sourced from clinicaltrials.gov

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