Pleurostrain: Interest of Strain Ultrasound in the Diagno... | NCT03907150

Studies
Pleurostrain: Interest of Strain Ultrasound in the Diagnosis of Pneumothorax

NCT03907150

Sponsor

Centre Hospitalier Universitaire de Nīmes

Status

Completed

Last Update Posted

Jul 13, 2020Actual

Enrollment

122Actual

Phase

Not provided

Conditions

Pneumothorax

Interventions

Strain ultrasound

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 13, 2019Actual

Primary Completion Date

Jun 20, 2020Actual

Completion Date

Jun 20, 2020Actual

First Submitted Date

Apr 3, 2019

First Submission Date that Met QC Criteria

Apr 5, 2019

First Posted Date

Apr 8, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 10, 2020

Last Update Posted Date

Jul 13, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Xavier Bobbia, Principal Investigator, Centre Hospitalier Universitaire de NīmesPrincipal Investigator

Lead Sponsor

Centre Hospitalier Universitaire de NīmesOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

122Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pneumothorax		Pneumothorax	Diagnostic Test: Strain ultrasound
Normal		Normal lung	Diagnostic Test: Strain ultrasound

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Strain ultrasound	Diagnostic Test	Post-interpretation of recorded ultrasound loops	Normal Pneumothorax

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hôpital La Timone		Marseille		13005	France
AP-HM - Hopital Nord

ID	Term
D010995	Pleural Diseases
D012140	Respiratory Tract Diseases