Evaluation of Thoracic Ultrasound in Monitoring Pleural Drainage in Postoperative Thoracic Surgery

Thoracic Ultrasound Clinical Trial

— EchTHor  

Official title:

Evaluation of Thoracic Ultrasound in Monitoring Pleural Drainage in Postoperative Thoracic Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05545566
• Other study ID #: 87RI22_0022 (EchTHor)
• Status: Completed
• Phase: N/A
• Start date: September 5, 2022
• Est. completion date: February 28, 2023

Study information

• Verified date: March 2023
• Source: University Hospital, Limoges
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 28, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm, Dissecting
• Thoracic Ultrasound

Intervention

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.

Locations

Country	Name	City	State
France	Limoges Univesity Hospital	Limoges

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Theoretical patient discharge	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	Pain du to examination	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
Secondary	Subcutaneous emphysema	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
Secondary	Pneumothorax	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
Secondary	Pleural effusion	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
Secondary	Pulmonary Condensation	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