Replaceability of Fluoroscopy and Ultrasound in the Evaluation of Hemidiaphragm Excursion
1 other identifier
observational
42
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 17, 2019
CompletedFirst Posted
Study publicly available on registry
September 23, 2019
CompletedStudy Start
First participant enrolled
May 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedResults Posted
Study results publicly available
December 12, 2024
CompletedDecember 12, 2024
March 1, 2023
1.1 years
September 17, 2019
March 17, 2023
December 9, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Diaphragm Function
Movement of diaphragm measured with ultrasound Ultrasound measures: Diaphragm excursion in centimeters with M-mode.
during intervention, up to 1 hour
Study Arms (1)
Participants
Participants undergoing ultrasound and fluoroscopy assessment of diaphragm excursion.
Interventions
Ultrasound and radiographic evaluation of diaphragm function
Eligibility Criteria
Healthy participants. Participants with prior COVID-19 infection. Participants with lung diseases. Participants with heart diseases.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Søren Helbo Skaarup
Aarhus, 8200, Denmark
Results Point of Contact
- Title
- Søren Helbo Skaarup
- Organization
- Aarhus University Hospital
Study Officials
- STUDY CHAIR
Søren H Skaarup
Aarhus University Hospital
- STUDY CHAIR
Peter Juhl-Olsen
Aarhus University Hospital
- STUDY CHAIR
Brian Løgstrup
Aarhus University Hospital
- STUDY CHAIR
Thomas Birkelund
Aarhus University Hospital
- STUDY CHAIR
Morten Bendixen
Aarhus University Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 17, 2019
First Posted
September 23, 2019
Study Start
May 1, 2020
Primary Completion
June 1, 2021
Study Completion
December 31, 2021
Last Updated
December 12, 2024
Results First Posted
December 12, 2024
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share