Sonographic Diaphragm Function in AECOPD

Copd Clinical Trial

— UNDATED  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05671198
• Other study ID #: Diaphragm 002
• Status: Recruiting
• Start date: March 27, 2023
• Est. completion date: August 2024

Study information

• Verified date: April 2023
• Source: Isala
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 51
• Est. completion date: August 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Copd

Intervention

Diagnostic Test:
• Ultrasound of the diaphragm
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).

Locations

Country	Name	City	State
Netherlands	Isala Klinieken	Zwolle	Overijssel

Sponsors (1)

Lead Sponsor	Collaborator
Isala

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	- 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	from admission till hospital discharge (expected median of 5 days based on experience)