Sonographic Diaphragm Function in AECOPD (UNDATED)

October 2, 2024 updated by: Wytze de Boer, Isala

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

51

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Netherlands
    • Overijssel
      • Zwolle, Overijssel, Netherlands, 8025AB
        • Recruiting
        • Isala Klinieken
        • Contact:
        • Contact:
          • Wytze de Boer, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
- 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
from admission till hospital discharge (expected median of 5 days based on experience)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Isala

Investigators

  • Study Director: Marieke Duiverman, M.D. PhD., UMCG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 27, 2023

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

December 20, 2022

First Submitted That Met QC Criteria

December 20, 2022

First Posted (Actual)

January 4, 2023

Study Record Updates

Last Update Posted (Actual)

October 4, 2024

Last Update Submitted That Met QC Criteria

October 2, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Diaphragm 002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Copd

Clinical Trials on Ultrasound of the diaphragm

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kenya

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe