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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.
Fluoroscopy assessment of diaphragm motility is obtained and simultaneously correlated to sonographic assessments of motility.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants | Participants undergoing ultrasound and fluoroscopy assessment of diaphragm excursion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diaphragm evaluation | Diagnostic Test | Ultrasound and radiographic evaluation of diaphragm function |
|
| Measure | Description | Time Frame |
|---|---|---|
| Diaphragm Function | Movement of diaphragm measured with ultrasound Ultrasound measures: Diaphragm excursion in centimeters with M-mode. | during intervention, up to 1 hour |
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Inclusion Criteria:
Completed informed consent
one of the following conditions:
Healthy participants, control group
Lung disease group.
Heart disease group.
Heart disease that lead to:
Exclusion Criteria:
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Healthy participants. Participants with prior COVID-19 infection. Participants with lung diseases. Participants with heart diseases.
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Søren Helbo Skaarup | Aarhus | 8200 | Denmark |
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants | Participants undergoing ultrasound and fluoroscopy assessment of diaphragm excursion. Diaphragm evaluation: Ultrasound and radiographic evaluation of diaphragm function |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants | Participants undergoing ultrasound and fluoroscopy assessment of diaphragm excursion. Diaphragm evaluation: Ultrasound and radiographic evaluation of diaphragm function |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Diaphragm Function | Movement of diaphragm measured with ultrasound Ultrasound measures: Diaphragm excursion in centimeters with M-mode. | Posted | Mean | Standard Deviation | centimeters | during intervention, up to 1 hour |
|
|
Immediate after intervention, up to one hour.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Participants | Participants undergoing ultrasound and fluoroscopy assessment of diaphragm excursion. Diaphragm evaluation: Ultrasound and radiographic evaluation of diaphragm function |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Søren Helbo Skaarup | Aarhus University Hospital | +4528911869 | soeska@rm.dk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 15, 2019 | Jan 8, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 15, 2019 | Dec 9, 2024 | ICF_001.pdf |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Height, cm | Mean | Standard Deviation | Centimeters |
|
| Weight. Kg | Mean | Standard Deviation | kilograms |
|
|
|
| 0 |
| 42 |
| 0 |
| 42 |
| 0 |
| 42 |
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