Assessing the DIAphragM Before ANd After Endobronchial Valve Treatment

NCT04735731 | Completed

• 1 other identifier: DIAMANT-study
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Emphysema

Outcome Measures

Primary Outcomes (1)

• Change in diaphragm motion measured by ultrasound

  Change in diaphragm motion 6 week after EBV treatment measured by ultrasound.

  6 weeks

Study Arms (1)

EBV-patients

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

Diagnostic Test: Echography

Interventions

Echography DIAGNOSTIC_TEST

Echography of diaphragma and other respiratory muscles

EBV-patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with severe emphysema who undergo a bronchoscopic lung volume reduction treatment with one-way endobronchial valves.

You may qualify if:

• Patient is scheduled for a bronchoscopic lung volume treatment using one-way valves
• Patient read, understood and signed the Informed Consent Form

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

UMCG Groningen

Groningen, 9713 GZ, Netherlands

Location

MeSH Terms

Conditions

Emphysema

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Dirk-Jan Slebos, PhD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: January 29, 2021
• First Posted: February 3, 2021
• Study Start: January 28, 2023
• Primary Completion: February 13, 2024
• Study Completion: February 13, 2024
• Last Updated: February 15, 2024

Record last verified: 2024-02

Locations

NL (1)