Pleurostrain: Interest of Strain Ultrasound in the Diagnosis of Pneumothorax

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

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.

Study Overview

• Status: Completed
• Conditions: Pneumothorax
• Intervention / Treatment: Diagnostic test: Strain ultrasound

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 122

Contacts and Locations

Study Locations

• France
  • Marseille, France, 13005
    • Hôpital La Timone
  • Marseille, France, 13915
    • AP-HM - Hôpital Nord
  • Nimes, France, 30029
    • Nîmes University Hospital
  • Nîmes, France, 30029
    • CHU Nîmes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Emergency Department or critical care patient who had a chest CT within 2 hours

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pneumothorax	Diagnostic test: Strain ultrasound; Post-interpretation of recorded ultrasound loops
Normal; Normal lung	Diagnostic test: Strain ultrasound; Post-interpretation of recorded ultrasound loops

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pneumothorax diagnosis by an inexperienced physician in lung ultrasound	The main endpoint will be a binary qualitative value: diagnosis of pneumothorax (yes/no) judged by inexperienced physicians performing pleural strain.	May 1, 2021

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2019
• Primary Completion (Actual): June 20, 2020
• Study Completion (Actual): June 20, 2020

Study Registration Dates

• First Submitted: April 3, 2019
• First Submitted That Met QC Criteria: April 5, 2019
• First Posted (Actual): April 8, 2019

Study Record Updates

• Last Update Posted (Actual): July 13, 2020
• Last Update Submitted That Met QC Criteria: July 10, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Pont-of-Care Ultrasound
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Pleural Diseases; Pneumothorax
• Other Study ID Numbers: XBobbia/Pleurostrain

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No