Evaluation of Diaphragm Movement

Vurdering af Diafragmas Funktion. Et Metodestudie og et Klinisk Studie

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.

Study Overview

• Status: Unknown
• Conditions: Diaphragm Disease
• Intervention / Treatment: Diagnostic test: Diaphragm evaluation

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Søren H Skaarup; Phone Number: 28911869; Email: soeska@rm.dk

Study Locations

• Denmark
  • Aarhus, Denmark, 8200
    • Recruiting
    • Søren Helbo Skaarup
    • Contact: Søren H Skaarup; Phone Number: 28911869; Email: soeska@rm.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Group 1: Healthy participants. Group 2: Lung disease. Group 3: Heart disease.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: 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 record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2020
• Primary Completion (Anticipated): June 1, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: September 17, 2019
• First Submitted That Met QC Criteria: September 20, 2019
• First Posted (Actual): September 23, 2019

Study Record Updates

• Last Update Posted (Actual): March 27, 2020
• Last Update Submitted That Met QC Criteria: March 26, 2020
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: Diaphragm Study AUH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No