Clinical Trial Details
— Status: Withdrawn
Administrative data
NCT number |
NCT04678726 |
Other study ID # |
17-6203 |
Secondary ID |
|
Status |
Withdrawn |
Phase |
|
First received |
|
Last updated |
|
Start date |
July 2023 |
Est. completion date |
December 2025 |
Study information
Verified date |
November 2022 |
Source |
University Health Network, Toronto |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
This is a prospective, single-center, observational, cross-sectional cohort study, comparing
nurse-performed bedside lung ultrasound to standard portable CXR, for the detection of
pneumothorax in the cardiac surgery patient population, following chest tube removal. This
study aims to be conducted at an academic, tertiary adult center cardio-vascular intensive
care unit (CVICU at TGH).
Description:
To avoid the accumulation of blood and fluids in the mediastinum or pleural cavities after
cardiac surgery, mediastinal and pleural drains are routinely used. The rate of pneumothorax
following chest drain removal is approximately 1.5-13%, resulting in increased patient
morbidity and hospital stay. The standard method for the determination of pneumothorax (PNX)
in most institutions is to obtain a chest radiography (CXR) following chest tube removal, but
the reliability of the supine anteroposterior chest radiography is not utter, with up to 30%
of pneumothoraxes misdiagnosis. The delay of ordering, performing and interpreting a CXR post
mediastinal tube removal, results in potential delay in patients transfers, with an estimated
cost savings of omitting an additional chest radiography, of approximately $10 000 per year.
Lung ultrasound (LUS) is recommended for detection of pneumothorax as per evidence-based
guidelines and expert consensus. Lung ultrasound is a safe technique due to minimal
radiation, with the potential for immediate results when compared with the standard CXR. LUS
has high accuracy for PNX detection, with better pooled sensitivities (78.6%) when compared
to CXR (39.8%) and equal specificity (98.4 vs 99.3%). In intensive care units, those results
have been reproducible, with LUS having greater sensitivity than CXR for PNX diagnosis (0.87
vs 0.46) and equal specificity, 0.99 vs 1.00. LUS is more accurate and faster than chest
radiography.