Evaluation of Thoracic Ultrasound in Monitoring Pleural Drainage in Postoperative Thoracic Surgery (EchTHor)

March 15, 2023 updated by: University Hospital, Limoges
The investigator would like to conduct a study in patients undergoing thoracic surgery to evaluate the effectiveness of thoracic ultrasound in the decision to discharge the patient after pleural drain removal.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Thoracic drainage is a common and almost systematic practice after thoracic surgery requiring daily management and monitoring until and after its removal.

It allows, after opening the pleura, the evacuation of liquid and/or air retained in the pleural cavity.

The overall monitoring of the patient after thoracic surgery is based on clinical vigilance combined with thoracic imaging, in particular the chest X-ray which remains the Gold Standard (reference examination).

The removal of the drain is decided according to the quantity and appearance of the evacuated fluid, the persistence of air leaks, etc… A few hours after the removal of the drain, it is routine to perform a chest X-ray before authorizing a possible discharge from the department.

This practice does not correspond to an established scientific protocol but is systematically performed in our department before discharge.

Several studies have defended the place of ultrasound in thoracic imaging and its contribution to the detection of postoperative and intensive care complications.

Unlike radiography, this technique is non-irradiating, less expensive and more readily available. It allows the detection of pneumothorax, pleural effusions and other complications detectable on X-ray.

To our knowledge, the contribution of thoracic ultrasound has not been studied in the decision to authorize the discharge of the patient after removal of the thoracic drain.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Limoges, France, 87042
        • Limoges Univesity Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Patients undergoing thoracic surgery (lung resection, pleural symphysis, biopsy or resection of a mediastinal tumor or ganglion, pleural decortication/decalcification) admitted immediately after surgery in the thoracic surgery department (standard care or continuous care) of the University Hospital of Limoges.

Exclusion Criteria:

  • Admission to the intensive care unit after thoracic surgery.
  • Pneumonectomy
  • Chest wall surgery
  • Patients <18 years old
  • Not affiliated to social security
  • Under guardianship or curatorship
  • Pregnant women
  • Not knowing the French language

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: All patients
Procedure: Thoracic ultrasound versus chest X-ray

Perform un ultrasound test, in addition to Chest X-Ray (usual practice), few hours after the surgery (D0), the next day (D1) and 4 to 6 hours after drain removal.

The data are collected in the standardized protocol for the two type of imaging.

The thoracic ultrasound and the Chest X-Ray are performed, blindly each other, in the same position for the patient and the same suction level of drain.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Theoretical patient discharge
Time Frame: At the study completion, an average of 10 days

Theoretical patient discharge based on imaging data (pleural ultrasound or chest x-ray):

  • YES: Score ≤ 2 on each of the 4 items assessed AND total score ≤ 4.
  • NO: Score ≥ 3 on each of the items assessed and/or total score ≥ 5.
At the study completion, an average of 10 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain du to examination
Time Frame: Day 0, Day 1 and At the study completion, an average of 10 days
To compare the pain generated by each examination (thoracic radiography and pleural ultrasound) with Visual Analogic Scale (0 to 10) at Day 0, Day 1 and post-drainage)
Day 0, Day 1 and At the study completion, an average of 10 days
Subcutaneous emphysema
Time Frame: Day 0, Day 1 and At the study completion, an average of 10 days
Evaluation of the concordance of pleural ultrasound data and chest radiography on the presence of subcutaneous emphysema at D0, D1 and post drain removal.
Day 0, Day 1 and At the study completion, an average of 10 days
Pneumothorax
Time Frame: Day 0, Day 1 and At the study completion, an average of 10 days
Evaluation of the concordance of pleural ultrasound data and chest radiography on the presence of Pneumothorax at D0, D1 and post drain removal.
Day 0, Day 1 and At the study completion, an average of 10 days
Pleural effusion
Time Frame: Day 0, Day 1 and At the study completion, an average of 10 days
Evaluation of the concordance of pleural ultrasound data and chest radiography on the presence of Pleural effusion at D0, D1 and post drain removal.
Day 0, Day 1 and At the study completion, an average of 10 days
Pulmonary Condensation
Time Frame: Day 0, Day 1 and At the study completion, an average of 10 days
Evaluation of the concordance of pleural ultrasound data and chest radiography on the presence of Pulmonary Condensation at D0, D1 and post drain removal.
Day 0, Day 1 and At the study completion, an average of 10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Limoges

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 5, 2022

Primary Completion (Actual)

February 28, 2023

Study Completion (Actual)

February 28, 2023

Study Registration Dates

First Submitted

September 10, 2022

First Submitted That Met QC Criteria

September 14, 2022

First Posted (Actual)

September 19, 2022

Study Record Updates

Last Update Posted (Actual)

March 16, 2023

Last Update Submitted That Met QC Criteria

March 15, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 87RI22_0022 (EchTHor)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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