Diaphragm Disease
Conditions
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.
Interventions
DIAGNOSTIC_TESTDiaphragm evaluation
Ultrasound and radiographic evaluation of diaphragm function
Sponsors
University of Aarhus
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diaphragm Function | during intervention, up to 1 hour | Movement of diaphragm measured with ultrasound Ultrasound measures: Diaphragm excursion in centimeters with M-mode. |
Countries
Denmark
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Participants Participants undergoing ultrasound and fluoroscopy assessment of diaphragm excursion.
Diaphragm evaluation: Ultrasound and radiographic evaluation of diaphragm function | 42 |
| Total | 42 |
Baseline characteristics
| Characteristic | Participants |
|---|---|
| Age, Continuous | 59.7 years STANDARD_DEVIATION 13.3 |
| Height, cm | 176.7 Centimeters STANDARD_DEVIATION 10.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 42 Participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 27 Participants |
| Weight. Kg | 81.9 kilograms STANDARD_DEVIATION 17.4 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 42 |
| other Total, other adverse events | 0 / 42 |
| serious Total, serious adverse events | 0 / 42 |
Outcome results
Primary
Diaphragm Function
Movement of diaphragm measured with ultrasound Ultrasound measures: Diaphragm excursion in centimeters with M-mode.
Time frame: during intervention, up to 1 hour
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants | Diaphragm Function | 4.25 centimeters | Standard Deviation 2.05 |
p-value: <0.0595% CI: [0.26, 1.04]Bland-Altman plots