Sonographic Diaphragm Function in AECOPD

NCT ID: NCT05671198

Last Updated: 2024-10-04

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 51 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-03-27
• Study Completion Date: 2025-08-31

Brief 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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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).

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Isala

OTHER

Sponsor Role: lead

Responsible Party

Wytze de Boer

Coördinating Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marieke Duiverman, M.D. PhD.

Role: STUDY_DIRECTOR

UMCG

Locations

Isala Klinieken

Zwolle, Overijssel, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

wytze s de Boer, m.d.

Role: CONTACT

w.s.de.boer@isala.nl

00316463120231

Facility Contacts

Wytze de Boer, MD

Role: primary

w.s.de.boer@isala.nl

+31646312031

Wytze de Boer, MD

Role: backup

Other Identifiers

Diaphragm 002

Identifier Type: -

Identifier Source: org_study_id