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Replaceability of Fluoroscopy and Ultrasound in the Evaluation of Hemidiaphragm Excursion

NCT ID: NCT04098939

Last Updated: 2024-12-12

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

42 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-01

Study Completion Date

2021-12-31

Brief Summary

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Precise measurement of diaphragm function is difficult. Several methods exist. No are sufficiently validated.

With this study, the investigators wish to investigate the validity of different ultrasound and radiological methods and compare them with inspiratory pressure measurements.

Detailed Description

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Fluoroscopy assessment of diaphragm motility is obtained and simultaneously correlated to sonographic assessments of motility.

Conditions

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Diaphragm Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants

Participants undergoing ultrasound and fluoroscopy assessment of diaphragm excursion.

Diaphragm evaluation

Intervention Type DIAGNOSTIC_TEST

Ultrasound and radiographic evaluation of diaphragm function

Interventions

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Diaphragm evaluation

Ultrasound and radiographic evaluation of diaphragm function

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Completed informed consent
* one of the following conditions:

* Healthy participants, control group
* Lung disease group.

* COPD or
* Ideopatic pulmonary fibrosis.
* Heart disease group.

Heart disease that lead to:

* heart transplantat or
* left ventricular assist device.

Exclusion Criteria

* Known diaphragm dysfunction.
* Neuromuscular disease.
* Pleural effusion.
* Pneumothorax.
* In the healthy group: Significant comorbidity that affect heart og lung function (arterial hypertention, mild valve disease and COPD without symptoms are accepted).
* In the healthy group and in the lung disease group: Previous thorax surgery.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Søren H Skaarup

Role: STUDY_CHAIR

Aarhus University Hospital

Peter Juhl-Olsen

Role: STUDY_CHAIR

Aarhus University Hospital

Brian Løgstrup

Role: STUDY_CHAIR

Aarhus University Hospital

Thomas Birkelund

Role: STUDY_CHAIR

Aarhus University Hospital

Morten Bendixen

Role: STUDY_CHAIR

Aarhus University Hospital

Locations

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Søren Helbo Skaarup

Aarhus, , Denmark

Site Status

Countries

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Denmark

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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Diaphragm Study AUH

Identifier Type: -

Identifier Source: org_study_id