Nurse-performed Lung Ultrasound Versus Chest Radiography... | NCT04678726

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

NCT04678726

Sponsor

University Health Network, Toronto

Status

Withdrawn

Last Update Posted

Mar 7, 2024Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Pneumothorax
Cardiac Surgery

Interventions

Lung ultrasound assessment for ruling out pneumothorax

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2022

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

COVID interference in the ability to initiate the study.

Expanded Access Info

Start Date

Jul 2023Estimated

Primary Completion Date

Jan 2024Estimated

Completion Date

Dec 2025Estimated

First Submitted Date

Dec 16, 2020

First Submission Date that Met QC Criteria

Dec 16, 2020

First Posted Date

Dec 22, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 5, 2024

Last Update Posted Date

Mar 7, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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).

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lung ultrasound assessment for ruling out pneumothorax	Diagnostic Test	Patients who have undergone heart surgery and have decided to enroll in our study, will have the standard chest x-ray and an additional lung ultrasound. Within a maximum of two hours of the chest tube removal, the standard chest x-ray will be performed, and then a different nurse will perform the lung ultrasound to check for pneumothorax.		Portable chest x-ray

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

CVICU patients after cardiac surgery

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jacobo Moreno Garijo, MD	Sunnybrook Health Science Centre	Principal Investigator
Azad Mashari, MD	University Health Network, Toronto	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011030	Pneumothorax

Ancestor Terms

ID	Term
D010995	Pleural Diseases
D012140	Respiratory Tract Diseases

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