Evaluation of Diaphragm Movement

• Sponsor: University of Aarhus (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04098939
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 20
• Patients Per Site Per Month: 5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diaphragm Disease	Diagnostic Test: Diaphragm evaluation

Study Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Vurdering af Diafragmas Funktion. Et Metodestudie og et Klinisk Studie
• Anticipated Study Start Date: May 1, 2020
• Anticipated Primary Completion Date: Jun 1, 2021
• Anticipated Study Completion Date: Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Healthy participants Participants without any known cardiac or pulmonary disease.	Diagnostic Test: Diaphragm evaluation; Ultrasound and radiographic evaluation of diaphragm function
Heart disease participants Participants with heart disease.	Diagnostic Test: Diaphragm evaluation; Ultrasound and radiographic evaluation of diaphragm function
Lung disease participants Participants with lung disease.	Diagnostic Test: Diaphragm evaluation; Ultrasound and radiographic evaluation of diaphragm function

Outcome Measures

Primary Outcome Measures

1. Diaphragm function [immediately after intervention]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Søren Helbo Skaarup	Aarhus		Denmark	8200

Sponsors and Collaborators

• University of Aarhus

Investigators

• 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Aarhus
• ClinicalTrials.gov Identifier: NCT04098939
• Other Study ID Numbers: Diaphragm Study AUH
• First Posted: Sep 23, 2019
• Last Update Posted: Mar 27, 2020
• Last Verified: Sep 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Mar 27, 2020