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Completed

NCT Number: NCT03907150

Pleurostrain: Interest of Strain Ultrasound in the Diagnosis of Pneumothorax

The objective of this study is to investigate whether the use of strain ultrasound can improve the lung ultrasound accuracy for the diagnosis of pneumothorax, particularly for inexperienced physicians.

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Key information

Conditions

Pneumothorax Pleural Diseases Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AP-HM - Hopital Nord, Marseille, France

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About this study

Prospective multi-centre diagnostic study based on the post-interpretation of recorded ultrasound loops as part of standard patient management.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age over 17 years old
  • Management in an investigative centre
  • Presenting a suspicion of pneumothorax
  • Having had a pulmonary ultrasound scan
  • Having had a CT scan within 2 hours after or before the pulmonary ultrasound

Exclusion criteria

  • Pregnant or breastfeeding women
  • Persons not covered by a social security scheme
  • Persons deprived of their liberty
  • The patient is participating in another study
  • The patient is in an exclusion period determined by a previous study
  • The patient is under the protection of justice, guardianship or curatorship
  • Patient refuses to participate
  • It is impossible to give informed information about
  • The patient does not read French fluently
  • Patient with any known pulmonary pathology pre-existing prior to the hospitalization episode
  • Patient with a lung condition other than pneumothorax on a scanner

Treatment and study plan

Strain ultrasound

Diagnostic Test

Post-interpretation of recorded ultrasound loops

Primary outcomes

  1. Pneumothorax diagnosis by an inexperienced physician in lung ultrasound

    Time frame: May 1, 2021

    The main endpoint will be a binary qualitative value: diagnosis of pneumothorax (yes/no) judged by inexperienced physicians performing pleural strain.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

Interest of Strain Ultrasound in the Diagnosis of Pneumothorax: Prospective Multicenter Observational Study

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 8, 2019
Registry last updated
Jul 13, 2020

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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