Evaluation of Diaphragm Movement

Diaphragm Disease Clinical Trial

Official title:

Vurdering af Diafragmas Funktion. Et Metodestudie og et Klinisk Studie

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04098939
• Other study ID #: Diaphragm Study AUH
• Status: Recruiting
• Start date: May 1, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: September 2019
• Source: University of Aarhus
• Contact: Søren H Skaarup
• Phone: 28911869
• Email: soeska[@]rm.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diaphragm Disease

Intervention

Diagnostic Test:
• Diaphragm evaluation
Ultrasound and radiographic evaluation of diaphragm function

Locations

Country	Name	City	State
Denmark	Søren Helbo Skaarup	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diaphragm function	Movement of diaphragm measured with ultrasound and radiography. Ultrasound measures: Diaphragm excursion in centimeters with M-mode, in B-mode and with the area method.; Radiographic measures: Craio-caudal movement in centimeters with flouroscopy.	immediately after intervention