Pleurostrain: Interest of Strain Ultrasound in the Diagnosis of Pneumothorax

Pneumothorax Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03907150
• Other study ID #: XBobbia/Pleurostrain
• Status: Completed
• Start date: February 13, 2019
• Est. completion date: June 20, 2020

Study information

• Verified date: July 2020
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: June 20, 2020
• Est. primary completion date: June 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pneumothorax

Intervention

Diagnostic Test:
• Strain ultrasound
Post-interpretation of recorded ultrasound loops

Locations

Country	Name	City	State
France	AP-HM - Hopital Nord	Marseille
France	Hôpital La Timone	Marseille
France	Nimes University hospital	Nimes
France	CHU Nîmes	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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