Replaceability of Fluoroscopy and Ultrasound in the Evaluation of Hemidiaphragm Excursion

Completed

• Conditions: Diaphragm Disease
• Interventions: Diagnostic Test: Diaphragm evaluation

• Registration Number: NCT04098939
• Lead Sponsor: University of Aarhus

Brief Summary

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

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

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2019-09-17
• Study First Submitted QC: 2019-09-20
• Study First Posted: 2019-09-23
• Study Start: 2020-05-01
• Primary Completion: 2021-06-01
• Study Completion: 2021-12-31
• Status Verified: 2023-03
• Results First Submitted: 2023-03-17
• Results First Submitted QC: 2024-12-09
• Last Update Submitted: 2024-12-09
• Results First Posted: 2024-12-12
• Last Update Posted: 2024-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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.

Read More

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.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy participants	Diaphragm evaluation	Participants without any known cardiac or pulmonary disease.
Lung disease participants	Diaphragm evaluation	Participants with lung disease.
Heart disease participants	Diaphragm evaluation	Participants with heart disease.

Primary Outcome Measures

Name	Time	Method
Diaphragm Function	during intervention, up to 1 hour	Movement of diaphragm measured with ultrasound Ultrasound measures: Diaphragm excursion in centimeters with M-mode.

Trial Locations

Locations (1)

Søren Helbo Skaarup; 🇩🇰 Aarhus, Denmark