NCT03907150

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2019

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 13, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 3, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 8, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2020

Completed
Last Updated

July 13, 2020

Status Verified

July 1, 2020

Enrollment Period

1.4 years

First QC Date

April 3, 2019

Last Update Submit

July 10, 2020

Conditions

Pneumothorax

Keywords

Pont-of-Care Ultrasound

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Pneumothorax

Pneumothorax

Diagnostic Test: Strain ultrasound

Normal

Normal lung

Diagnostic Test: Strain ultrasound

Interventions

Strain ultrasoundDIAGNOSTIC_TEST

Post-interpretation of recorded ultrasound loops

NormalPneumothorax

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hôpital La Timone

Marseille, 13005, France

Location

AP-HM - Hopital Nord

Marseille, 13915, France

Location

CHU Nîmes

Nîmes, 30029, France

Location

Nimes University hospital

Nîmes, 30029, France

Location

MeSH Terms

Conditions

Pneumothorax

Condition Hierarchy (Ancestors)

Pleural DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 3, 2019

First Posted

April 8, 2019

Study Start

February 13, 2019

Primary Completion

June 20, 2020

Study Completion

June 20, 2020

Last Updated

July 13, 2020

Record last verified: 2020-07

Locations

FR(4)