Sonographic Diaphragm Function in AECOPD

NCT05671198 | Recruiting DMC

• 1 other identifier: Diaphragm 002
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Copd

Keywords

diaphragm; COPD; thoracic ultrasound

Outcome Measures

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.

  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)

Interventions

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Our population consists of 18-years or older patients who are hospitalised primarily due to AECOPD without respiratory acidosis.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Isala: lead

Study Sites (1)

Isala Klinieken

Zwolle, Overijssel, 8025AB, Netherlands

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marieke Duiverman, M.D. PhD.

  University Medical Center Groningen

  STUDY DIRECTOR

Central Study Contacts

wytze s de Boer, m.d.

CONTACT

00316463120231; w.s.de.boer@isala.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coördinating Investigator

Study Record Dates

• First Submitted: December 20, 2022
• First Posted: January 4, 2023
• Study Start: March 27, 2023
• Primary Completion: March 1, 2025
• Study Completion: August 1, 2025
• Last Updated: October 4, 2024

Record last verified: 2024-10

Locations

NL (1)