Pleurostrain: Interest of Strain Ultrasound in the Diagnosis of Pneumothorax

Completed

• Conditions: Pneumothorax
• Interventions: Diagnostic Test: Strain ultrasound

• Registration Number: NCT03907150
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief 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.

Detailed Description

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

Study Timeline

• Study Start: 2019-02-13
• Study First Submitted: 2019-04-03
• Study First Submitted QC: 2019-04-05
• Study First Posted: 2019-04-08
• Primary Completion: 2020-06-20
• Study Completion: 2020-06-20
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-10
• Last Update Posted: 2020-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pneumothorax	Strain ultrasound	Pneumothorax
Normal	Strain ultrasound	Normal lung

Primary Outcome Measures

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

Trial Locations

Locations (4)

AP-HM - Hopital Nord; 🇫🇷 Marseille, France

CHU Nîmes; 🇫🇷 Nîmes, France

Hôpital La Timone; 🇫🇷 Marseille, France

Nimes University hospital; 🇫🇷 Nimes, France