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Sonographic Diaphragm Function in AECOPD (UNDATED)

I

Isala

Status

Enrolling

Conditions

Copd

Treatments

Diagnostic Test: Ultrasound of the diaphragm

Study type

Observational

Funder types

Other

Identifiers

NCT05671198
Diaphragm 002

Details and patient eligibility

About

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.

Full 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.

Enrollment

51 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Central trial contact

wytze s de Boer, m.d.

Data sourced from clinicaltrials.gov

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