Bedside Ultrasound in Detection of Pneumothorax Post Transthoracic Lung Biopsy
Primary Purpose
Pneumothorax
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Ultrasound (US) Imaging
Sponsored by
About this trial
This is an interventional screening trial for Pneumothorax focused on measuring Chest X-ray, Ultrasound
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Other patients.
Sites / Locations
- Hamid Bayanati
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ultrasound Imaging
Arm Description
A Single Ultrasound Imaging to diagnose of pneumothorax post transthoracic lung biopsy.
Outcomes
Primary Outcome Measures
Diagnostic Accuracy
To determine if the sensitivity and specificity of US is equal or better than routine CXR in diagnosing pneumothorax post lung biopsy.
Secondary Outcome Measures
Full Information
NCT ID
NCT03397290
First Posted
October 31, 2017
Last Updated
September 1, 2021
Sponsor
Ottawa Hospital Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT03397290
Brief Title
Bedside Ultrasound in Detection of Pneumothorax Post Transthoracic Lung Biopsy
Official Title
Usefulness of Bedside Ultrasound in Detection of Pneumothorax Post Transthoracic Lung
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
May 25, 2018 (Actual)
Primary Completion Date
February 26, 2021 (Actual)
Study Completion Date
February 26, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ottawa Hospital Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Hypothesis:
US have sensitivity and specificity equal or better than CXR to exclude pneumothorax after transthoracic lung biopsy.
Clinical relevance:
Pneumothorax is a well-known complication of image-guided transthoracic biopsy of lung lesions. The incidence of pneumothorax in patients undergoing TTNB has been reported to be from 9% to 54% (ref. 3). Most of the time, the pneumothorax is small and requires no further intervention other than observation and a repeat CXR to ensure stability or resolution of the pneumothorax. In small group of patients with detected pneumothorax after biopsy, the pneumothorax is either large or becomes larger (more than 2 cm width at the level of the hilum) during observation. In these cases, a small pleural drainage catheter will be inserted to prevent the lung from collapsing. The catheter will be removed in 2 days. Detection of pneumothorax post biopsy is important to prevent possible lung collapse after discharge and currently is done by obtaining a CXR, 30 minutes after the biopsy.
Obtaining a CXR, requires moving the patient on stretcher to the X-ray room, bringing the patient to upright position, patient holds breath. An X-ray technologist obtains the CXR which will be reviewed by a Radiologist when it becomes available on work station. Then the Radiologist revisits the patient and orders the discharge.
Detection of pneumothorax by US is feasible and compare to current practice with CXR, is faster and do not need moving and repositioning the patient, therefore, more convenient. It can be easily performed at the time of clinical assessment prior to discharge.
Study design/ Methodology:
All patients coming for lung biopsy will be invited to participate in this study. Information about the one additional US at the time of their biopsy and routine CXR will be explained to the patient by either thoracic radiology fellow or staff radiologist.
For those who agree to participate, informed Consent will be obtained by the same people mentioned above.
There will be no change in clinical assessment or decision to discharge the patient after biopsy.
US will be performed by a trained staff radiologist or thoracic fellow.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumothorax
Keywords
Chest X-ray, Ultrasound
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ultrasound Imaging
Arm Type
Experimental
Arm Description
A Single Ultrasound Imaging to diagnose of pneumothorax post transthoracic lung biopsy.
Intervention Type
Device
Intervention Name(s)
Ultrasound (US) Imaging
Intervention Description
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
Primary Outcome Measure Information:
Title
Diagnostic Accuracy
Description
To determine if the sensitivity and specificity of US is equal or better than routine CXR in diagnosing pneumothorax post lung biopsy.
Time Frame
One year
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Other patients.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Betty Anne Schwarz, Ph.D.
Organizational Affiliation
Ottawa Hospital Research Institute
Official's Role
Study Director
Facility Information:
Facility Name
Hamid Bayanati
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4E9
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
26407979
Citation
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.
Results Reference
background
PubMed Identifier
23716522
Citation
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.
Results Reference
background
PubMed Identifier
24672704
Citation
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.
Results Reference
background
Learn more about this trial
Bedside Ultrasound in Detection of Pneumothorax Post Transthoracic Lung Biopsy
We'll reach out to this number within 24 hrs