NCT03397290

Brief Summary

Currently chest X-ray (CXR) is the modality used to assess for pneumothorax after transthoracic lung biopsy at the Ottawa Hospital. Recently bedside Ultrasound (US) has become a useful rapid imaging modality to assess chest for pneumothorax in emergency rooms with reported sensitivity, specificity and diagnostic accuracy were 88%, 97% and 97%, respectively (ref. 2). Our team will be comparing the diagnostic accuracy of US to CXR in diagnoses of pneumothorax post transthoracic lung biopsy. The purpose of the study is to compare the diagnostic accuracy of US to CXR post-biopsy to confirm the presence of a pneumothorax.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

October 31, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 11, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

May 25, 2018

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 26, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 26, 2021

Completed
Last Updated

September 5, 2021

Status Verified

September 1, 2021

Enrollment Period

2.8 years

First QC Date

October 31, 2017

Last Update Submit

September 1, 2021

Conditions

Keywords

Chest X-rayUltrasound

Outcome Measures

Primary Outcomes (1)

  • Diagnostic Accuracy

    To determine if the sensitivity and specificity of US is equal or better than routine CXR in diagnosing pneumothorax post lung biopsy.

    One year

Study Arms (1)

Ultrasound Imaging

EXPERIMENTAL

A Single Ultrasound Imaging to diagnose of pneumothorax post transthoracic lung biopsy.

Device: Ultrasound (US) Imaging

Interventions

Ultrasound (US) Imaging will be compared to the chest X-ray for diagnostic accuracy (sensitivity and specificity) in diagnoses of pneumothorax post transthoracic lung biopsy

Ultrasound Imaging

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who are booked and coming for image-guided transthoracic biopsy of a lung lesion to the Ottawa Hospital, General Campus, will be consented and those who agree to added US will be included

You may not qualify if:

  • Other patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hamid Bayanati

Ottawa, Ontario, K1Y 4E9, Canada

Location

Related Publications (3)

  • Quick JA, Uhlich RM, Ahmad S, Barnes SL, Coughenour JP. In-flight ultrasound identification of pneumothorax. Emerg Radiol. 2016 Feb;23(1):3-7. doi: 10.1007/s10140-015-1348-z. Epub 2015 Sep 25.

    PMID: 26407979BACKGROUND
  • Shostak E, Brylka D, Krepp J, Pua B, Sanders A. Bedside sonography for detection of postprocedure pneumothorax. J Ultrasound Med. 2013 Jun;32(6):1003-9. doi: 10.7863/ultra.32.6.1003.

    PMID: 23716522BACKGROUND
  • Boskovic T, Stanic J, Pena-Karan S, Zarogoulidis P, Drevelegas K, Katsikogiannis N, Machairiotis N, Mpakas A, Tsakiridis K, Kesisis G, Tsiouda T, Kougioumtzi I, Arikas S, Zarogoulidis K. Pneumothorax after transthoracic needle biopsy of lung lesions under CT guidance. J Thorac Dis. 2014 Mar;6 Suppl 1(Suppl 1):S99-S107. doi: 10.3978/j.issn.2072-1439.2013.12.08.

    PMID: 24672704BACKGROUND

MeSH Terms

Conditions

Pneumothorax

Interventions

UltrasonographyDiagnostic Imaging

Condition Hierarchy (Ancestors)

Pleural DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Betty Anne Schwarz, Ph.D.

    Ottawa Hospital Research Institute

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2017

First Posted

January 11, 2018

Study Start

May 25, 2018

Primary Completion

February 26, 2021

Study Completion

February 26, 2021

Last Updated

September 5, 2021

Record last verified: 2021-09

Locations