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

Sponsor

University Hospital, Limoges (Other)

Overall Status

Recruiting

CT.gov ID

NCT05545566

Collaborator

(none)

Enrollment

Location

Arm

6.3

Anticipated Duration (Months)

9.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Thoracic Ultrasound Pleural Drain Removal	Procedure: Thoracic ultrasound versus chest X-ray	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Sep 5, 2022

Anticipated Primary Completion Date :

Mar 15, 2023

Anticipated Study Completion Date :

Mar 15, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Theoretical patient discharge [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.

Secondary Outcome Measures

Pain du to examination [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)
Subcutaneous emphysema [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.
Pneumothorax [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.
Pleural effusion [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.
Pulmonary Condensation [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.