CopdUNDATEDNCT05671198
Sonographic Diaphragm Function in AECOPD
An observational study of Copd, run by Isala at 1 site in Netherlands.
Trial summary
The study will be conducted as a single-center, prospective cohort study. The primary objective of this study is to investigate the responsiveness of sonographic parameters of diaphragm to detect change in Borg score for dyspnea during hospitalisation for AECOPD without respiratory acidosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Copd
- What is being tested?
- Ultrasound of the diaphragm
- How many people
- 51 participants
- Where
- 1 siteNetherlands
- Study dates
- 27 Mar 2023to Aug 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: Our population consists of 18-years or older patients who are hospitalised primarily due to AECOPD without respiratory acidosis.
Who may be able to join
- Hospitalisation primarily because of severe acute exacerbation of COPD
- COPD, according to GOLD 2018 definition
- Post-bronchodilator FEV1/FVC < 0,70 and FEV1% < 80%pred. within last 5 years
Who cannot join
- Respiratory acidosis (pH < 7.35 ánd PaCO2 > 6 kPA)
- Need for (non-)invasive ventilation based on other criteria (e.g. severe hypoxia) upon presentation.
- Established diagnosis of diaphragm diaphragm paralysis.
- Inability for diaphragm imaging (e.g. mechanical ventilation, or unable to follow vocal instructions).
- Those not able or unwilling to give written informed consent.
- Pregnant women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Isala Klinieken
Zwolle, Overijssel, 8025AB
Wytze de Boer, MD, +31646312031, w.s.de.boer@isala.nl
Wytze de Boer, MD
About this study
Official title: Ultrasound of the Diaphragm As Physiological Biomarker in Acute Exacerbations of Chronic Obstructive Pulmonary Disease
The study will be conducted as a single-center, prospective cohort study. The primary objective of this study is to investigate the responsiveness of sonographic parameters of diaphragm to detect change in Borg score for dyspnea during hospitalisation for AECOPD without respiratory acidosis.
Read the detailed description
To investigate the responsiveness of sonographic parameters to detect change in Borg score for dyspnea during hospitalisation for AECOPD without respiratory acidosis, we propose a prospective cohort design.
After inclusion, participants will have assessment of diaphragm function (excursion, thickness, thickening fraction) using ultrasound within 48 hours of admission to the emergency ward, striving to assessment within 24 hours of admission. Additionally, dyspnea grade will be assessed using validated questionnaires.
Further diagnostic work-up and treatment for AECOPD is performed at the discretion of the treating physician.
Both ultrasound measurements and dyspnea grade questionnaires will be repeated when the participant is reported suitable for hospital discharge by the treating physician.
- Conditions
- Copd
- Being tested
- Ultrasound of the diaphragm
- Keywords
- diaphragm, COPD, thoracic ultrasound
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound of the diaphragmDiagnostic test
Sonographic parameters of the diaphragm:
- Thickening Fraction (TF); (Diaphragm thickness end-inspiration- Diaphragm thickness end-expiration) / Diaphragm thickness end-expiration. (continuous variable).
- Diaphragm end-expiratory thickness: Diaphragm thickness at end-expiration (continuous variable)
- Diaphragm excursion (DE): diaphragm inspiratory amplitude during deep breathing (continuous variable).
What is being measured
The primary outcome is the main question the study is designed to answer.
- To investigate the responsiveness of sonographic parameters to detect change in Borg score for dyspnea during hospitalisation for AECOPD without respiratory acidosis.
Correlation between:
- Change in Borg score for dyspnea; defined as score at discharge minus score at admission
- Change in sonographic parameters; defined as score at discharge minus score at admission
Measured: from admission till hospital discharge (expected median of 5 days based on experience)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2023
- Study start27 Mar 2023
- Primary completionMar 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CopdStudies of the same condition, open and under way.
- 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
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Isala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wytze de Boer, Isala
- Investigators
- Marieke Duiverman, M.D. PhD., Study director, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05671198
- Sponsor's protocol ID
- Diaphragm 002
- Acronym
- UNDATED
- Status last verified
- Oct 2024
- First submitted
- 20 Dec 2022
- Last updated
- 4 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound of the Diaphragm As Physiological Biomarker in Acute Exacerbations of Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT05671198
- Acronym / sponsor ID
- UNDATED / Diaphragm 002
- Conditions
- Copd
- Keywords
- diaphragm, COPD, thoracic ultrasound
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- IsalaUniversity, hospital or other
- Study start
- 27 Mar 2023 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 4 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will be conducted as a single-center, prospective cohort study. The primary objective of this study is to investigate the responsiveness of sonographic parameters of diaphragm to detect change in Borg score for dyspnea during hospitalisation for AECOPD without respiratory acidosis.
Detailed description
To investigate the responsiveness of sonographic parameters to detect change in Borg score for dyspnea during hospitalisation for AECOPD without respiratory acidosis, we propose a prospective cohort design.
After inclusion, participants will have assessment of diaphragm function (excursion, thickness, thickening fraction) using ultrasound within 48 hours of admission to the emergency ward, striving to assessment within 24 hours of admission. Additionally, dyspnea grade will be assessed using validated questionnaires.
Further diagnostic work-up and treatment for AECOPD is performed at the discretion of the treating physician.
Both ultrasound measurements and dyspnea grade questionnaires will be repeated when the participant is reported suitable for hospital discharge by the treating physician.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Our population consists of 18-years or older patients who are hospitalised primarily due to AECOPD without respiratory acidosis.
Key inclusion criteria (3 listed)
- Hospitalisation primarily because of severe acute exacerbation of COPD
- COPD, according to GOLD 2018 definition
- Post-bronchodilator FEV1/FVC < 0,70 and FEV1% < 80%pred. within last 5 years
Key exclusion criteria (6 listed)
- Respiratory acidosis (pH < 7.35 ánd PaCO2 > 6 kPA)
- Need for (non-)invasive ventilation based on other criteria (e.g. severe hypoxia) upon presentation.
- Established diagnosis of diaphragm diaphragm paralysis.
- Inability for diaphragm imaging (e.g. mechanical ventilation, or unable to follow vocal instructions).
- Those not able or unwilling to give written informed consent.
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 |
|---|---|---|
| Ultrasound of the diaphragmSonographic parameters of the diaphragm: * Thickening Fraction (TF); (Diaphragm thickness end-inspiration- Diaphragm thickness end-expiration) / Diaphragm thickness end-expiration. (continuous variable). * Diaphragm end-expiratory thickness: Diaphragm thickness at end-expiration (continuous variable) * Diaphragm excursion (DE): diaphragm inspiratory amplitude during deep breathing (continuous variable). | Diagnostic test | – |
Primary outcome
- To investigate the responsiveness of sonographic parameters to detect change in Borg score for dyspnea during hospitalisation for AECOPD without respiratory acidosis.
Time frame: from admission till hospital discharge (expected median of 5 days based on experience)
Correlation between: * Change in Borg score for dyspnea; defined as score at discharge minus score at admission * Change in sonographic parameters; defined as score at discharge minus score at admission
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2024.
- Individual participant dataSharing planned: Undecided
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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.
Marieke Duiverman, M.D. PhD. study director
University Medical Center Groningen
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 Copd, run by Isala at 1 site in Netherlands.
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 3 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: looking for participants now, as of the sponsor's last update on 4 Oct 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 Netherlands. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact wytze s de Boer, m.d. (00316463120231, w.s.de.boer@isala.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
- To investigate the responsiveness of sonographic parameters to detect change in Borg score for dyspnea during hospitalisation for AECOPD without respiratory acidosis. (time frame: from admission till hospital discharge (expected median of 5 days based on experience)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Oct 2024.