NCT04678726

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).

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2023

Typical duration for all trials

Status
withdrawn

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

December 16, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 22, 2020

Completed
2.5 years until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

March 7, 2024

Status Verified

November 1, 2022

Enrollment Period

6 months

First QC Date

December 16, 2020

Last Update Submit

March 5, 2024

Conditions

Keywords

Chest tube removal

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

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.

Also known as: Portable chest x-ray

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

CVICU patients after cardiac surgery

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pneumothorax

Condition Hierarchy (Ancestors)

Pleural DiseasesRespiratory Tract Diseases

Study Officials

  • Jacobo Moreno Garijo, MD

    Sunnybrook Health Science Centre

    PRINCIPAL INVESTIGATOR
  • Azad Mashari, MD

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2020

First Posted

December 22, 2020

Study Start

July 1, 2023

Primary Completion

January 1, 2024

Study Completion

December 1, 2025

Last Updated

March 7, 2024

Record last verified: 2022-11