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NCT Number: NCT05671198

Sonographic Diaphragm Function in AECOPD

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Isala Klinieken

Zwolle, Overijssel, 8025AB, Netherlands

Location status: Recruiting

Location contact

Wytze de Boer, MD

CONTACT

[email protected]

+31646312031

Wytze de Boer, MD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Ultrasound of the diaphragm

Diagnostic 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).

Primary outcomes

  1. - 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

Study contacts

Contact information is provided by the study sponsor or research team.

wytze s de Boer, m.d.

CONTACT

[email protected]

00316463120231

Sponsors and collaborators

Lead sponsor

Isala

Other

Registry information

Official study title

Ultrasound of the Diaphragm As Physiological Biomarker in Acute Exacerbations of Chronic Obstructive Pulmonary Disease

Acronym: UNDATED

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 4, 2023
Registry last updated
Oct 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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