NCT03827538

Brief Summary

This prospective study aims at evaluating diaphragmatic function before and after endobronchial valves positioning in a COPD patients with lung hyperinflation.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 1, 2019

Completed
8 months until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

May 10, 2023

Status Verified

May 1, 2023

Enrollment Period

4.3 years

First QC Date

January 28, 2019

Last Update Submit

May 9, 2023

Conditions

Diaphragm

Outcome Measures

Primary Outcomes (4)

  • Diaphrgam function test modification after ELVR

    Ultrasound assessed ΔTdi values change after ELVR

    90 days

  • Diaphrgam fatigue test modification after ELVR

    Ultrasound assessed ΔTmax values change after ELVR

    90 days

  • Diaphrgam performance test modification after ELVR

    Ultrasound assessed PEEPiecho values change after ELVR

    90 days

  • Diaphrgam motion test modification after ELVR

    US assessed maximal diaphragmatic inspiratory excursion after ELVR

    90 days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

See inclusion criteria

You may qualify if:

  • age\> 18
  • patient admission for intervention for endobronchial valves positioning due to documented lung hyperinflation.

You may not qualify if:

  • previously documented diaphragmatic dysfunction
  • the presence of neuromuscular diseases or other forms of myopathy
  • pregnancy
  • lack of collaboration in performing functional diaphragmatic tests

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Modena Policlinico

Modena, 41125, Italy

RECRUITING

Central Study Contacts

Marchioni Alessandro

CONTACT

00390594225859marchioni.alessandro@unimore.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 28, 2019

First Posted

February 1, 2019

Study Start

October 1, 2019

Primary Completion

December 31, 2023

Study Completion

December 31, 2024

Last Updated

May 10, 2023

Record last verified: 2023-05

Locations

IT(1)