Diaphragm DiseaseNCT04098939

Replaceability of Fluoroscopy and Ultrasound in the Evaluation of Hemidiaphragm Excursion

An observational study of Diaphragm Disease, run by University of Aarhus at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Diaphragm Disease
What is being tested?: Diaphragm evaluation
How many people: 42 participants
Where: 1 siteDenmark
Study dates: 1 May 2020to 31 Dec 2021
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Study population: Healthy participants. Participants with prior COVID-19 infection. Participants with lung diseases. Participants with heart diseases.

Who may be able to join

Completed informed consent
one of the following conditions:
Healthy participants, control group
Lung disease group.
COPD or
Ideopatic pulmonary fibrosis.

Show all 10Show fewer

Heart disease group.
Heart disease that lead to:
heart transplantat or
left ventricular assist device.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Denmark1 site

Søren Helbo Skaarup
Aarhus, 8200

Other trials in Denmark

About this study

Official title: Replaceability of Fluoroscopy and Ultrasound in the Evaluation of Hemidiaphragm Excursion"

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.

Read the detailed description

Fluoroscopy assessment of diaphragm motility is obtained and simultaneously correlated to sonographic assessments of motility.

Conditions: Diaphragm Disease
Being tested: Diaphragm evaluation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Diaphragm evaluationDiagnostic test
Ultrasound and radiographic evaluation of diaphragm function

Study groups in NCT04098939
Study group	Role	What they receive
Participants		Participants undergoing ultrasound and fluoroscopy assessment of diaphragm excursion. Receives: Diagnostic Test: Diaphragm evaluation

What is being measured

The primary outcome is the main question the study is designed to answer.

Diaphragm Function
Movement of diaphragm measured with ultrasound Ultrasound measures: Diaphragm excursion in centimeters with M-mode.
Measured: during intervention, up to 1 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 May 202031 Dec 2021

First posted23 Sep 2019
Study start1 May 2020
Primary completion1 Jun 2021
Study completion31 Dec 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Diaphragm DiseaseStudies of the same condition, open and under way.
More trials run by University of AarhusThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 42 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04098939
Sponsor's protocol ID: Diaphragm Study AUH
Status last verified: Mar 2023
First submitted: 17 Sep 2019
Last updated: 12 Dec 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Diaphragm Mobilization in Adolescent Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis
Enrolling by invitationObservational study
North American Fetal Therapy Network Prospective Registry for Long-term Outcome Following Fetoscopic Endoluminal Tracheal Occlusion in Severe Left and Right Congenital Diaphragmatic Hernia
Congenital Diaphragmatic Hernia
Active, not recruiting
Fetoscopic Endoluminal Tracheal Occlusion in Severe Left Congenital Diaphragmatic Hernia
Congenital Diaphragmatic Hernia, Pulmonary Hypoplasia
Recruiting
Inspiratory Muscle Training and Diaphragmatic Breathing in GAD
Generalized Anxiety Disorder (GAD)
Not yet recruiting
Abdominal Air-Pressure Resistance Versus Abdominal Weight Training for Improving Diaphragm Function in Healthy Young Adults
Diaphragm Thickness, Dyspnoea

All Diaphragm Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Replaceability of Fluoroscopy and Ultrasound in the Evaluation of Hemidiaphragm Excursion"
ClinicalTrials.gov ID: NCT04098939
Acronym / sponsor ID: Diaphragm Study AUH
Conditions: Diaphragm Disease
Study type: Observational
Recruitment status: Completed
Enrolment: 42 participants (actual)
Lead sponsor: University of AarhusUniversity, hospital or other
Study start: 1 May 2020 (actual)
Primary completion: 1 Jun 2021 (actual)
Study completion: 31 Dec 2021 (actual)
First posted: 23 Sep 2019 (actual)
Results: Posted 12 Dec 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Participants	–	Diagnostic Test: Diaphragm evaluationParticipants undergoing ultrasound and fluoroscopy assessment of diaphragm excursion.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: Healthy participants. Participants with prior COVID-19 infection. Participants with lung diseases. Participants with heart diseases.

Key inclusion criteria (10 listed)

Completed informed consent
one of the following conditions:
heart transplantat or
left ventricular assist device.

Key exclusion criteria (6 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Diaphragm evaluationUltrasound and radiographic evaluation of diaphragm function	Diagnostic test	Participants

Primary outcome

Diaphragm Function
Time frame: during intervention, up to 1 hour
Movement of diaphragm measured with ultrasound Ultrasound measures: Diaphragm excursion in centimeters with M-mode.

Results and safety

Results posted to the registry on 12 Dec 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Participants	42	42

Primary outcome: Diaphragm Function

Time frame: during intervention, up to 1 hour. Mean (Standard Deviation). Unit: centimeters

Measure	Participants n = 42
Value	4.25 (2.05)

Participants: Bland-Altman plots: 0.39 (95% CI 0.26 to 1.04), p <0.05, Bland-Altman plots

Adverse events

Time frame: Immediate after intervention, up to one hour.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Participants	0 of 42 (0%)	0 of 42 (0%)	0 of 42

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Diaphragm Disease

Active, not recruiting
Diaphragm Mobilization in Adolescent Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis
Enrolling by invitationObservational study
North American Fetal Therapy Network Prospective Registry for Long-term Outcome Following Fetoscopic Endoluminal Tracheal Occlusion in Severe Left and Right Congenital Diaphragmatic Hernia
Congenital Diaphragmatic Hernia
Active, not recruiting
Fetoscopic Endoluminal Tracheal Occlusion in Severe Left Congenital Diaphragmatic Hernia
Congenital Diaphragmatic Hernia, Pulmonary Hypoplasia
Recruiting
Inspiratory Muscle Training and Diaphragmatic Breathing in GAD
Generalized Anxiety Disorder (GAD)
Not yet recruiting
Abdominal Air-Pressure Resistance Versus Abdominal Weight Training for Improving Diaphragm Function in Healthy Young Adults
Diaphragm Thickness, Dyspnoea

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Søren H Skaarup study chair

Aarhus University Hospital

Peter Juhl-Olsen study chair

Aarhus University Hospital

Brian Løgstrup study chair

Aarhus University Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Diaphragm Disease, run by University of Aarhus at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diaphragm Function (time frame: during intervention, up to 1 hour). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04098939.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2024.