Nurse-performed Lung Ultrasound Versus Chest Radiography for Detection of Pneumothorax.

Nurse-performed Lung Ultrasound Versus Chest Radiography for Detection of Pneumothorax After Mediastinal Drainage Removal Post Cardiac Surgery.

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).

Study Overview

• Status: Withdrawn
• Conditions: Pneumothorax; Cardiac Surgery
• Intervention / Treatment: Diagnostic test: Lung ultrasound assessment for ruling out pneumothorax

Detailed 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.

• Study Type: Observational

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

CVICU patients after cardiac surgery

Description

Inclusion Criteria:

• Patients older than 18 years in the cardiovascular intensive care unit post cardiac surgery, with a chest tube removed within the past 2 hours.

Exclusion Criteria:

• Patients who were mechanically ventilated or with subcutaneous emphysema due to impaired pleural line visualization.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnosis of Pneumothorax	Assess the accuracy of nurse-performed lung ultrasound in the diagnosis of pneumothorax post chest tube removal after cardiac surgery compared to chest x-ray.	24 months

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Investigators: Principal Investigator: Jacobo Moreno Garijo, MD, Sunnybrook Health Science Centre; Principal Investigator: Azad Mashari, MD, University Health Network, Toronto

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2023
• Primary Completion (Estimated): January 1, 2024
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: December 16, 2020
• First Submitted That Met QC Criteria: December 16, 2020
• First Posted (Actual): December 22, 2020

Study Record Updates

• Last Update Posted (Actual): March 7, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Chest tube removal
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Pleural Diseases; Pneumothorax
• Other Study ID Numbers: 17-6203

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No