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Completed

NCT Number: NCT04098939

Replaceability of Fluoroscopy and Ultrasound in the Evaluation of Hemidiaphragm Excursion

Precise measurement of diaphragm function is difficult. Several methods exist. No are sufficiently validated.

With this study, the investigators wish to investigate the validity of different ultrasound and radiological methods and compare them with inspiratory pressure measurements.

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Key information

Conditions

Diaphragm Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Søren Helbo Skaarup

Aarhus, 8200, Denmark

About this study

Fluoroscopy assessment of diaphragm motility is obtained and simultaneously correlated to sonographic assessments of motility.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Completed informed consent
  • one of the following conditions:
  • Healthy participants, control group
  • Lung disease group.
  • COPD or
  • Ideopatic pulmonary fibrosis.
  • Heart disease group.

Heart disease that lead to:

  • heart transplantat or
  • left ventricular assist device.

Exclusion criteria

  • Known diaphragm dysfunction.
  • Neuromuscular disease.
  • Pleural effusion.
  • Pneumothorax.
  • In the healthy group: Significant comorbidity that affect heart og lung function (arterial hypertention, mild valve disease and COPD without symptoms are accepted).
  • In the healthy group and in the lung disease group: Previous thorax surgery.

Treatment and study plan

Diaphragm evaluation

Diagnostic Test

Ultrasound and radiographic evaluation of diaphragm function

Primary outcomes

  1. Diaphragm Function

    Time frame: during intervention, up to 1 hour

    Movement of diaphragm measured with ultrasound Ultrasound measures: Diaphragm excursion in centimeters with M-mode.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

Replaceability of Fluoroscopy and Ultrasound in the Evaluation of Hemidiaphragm Excursion"

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 23, 2019
Registry last updated
Dec 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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