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

NCT05545566 | Completed

• 1 other identifier: 87RI22_0022 (EchTHor)
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Thoracic Ultrasound; Pleural Drain Removal

Keywords

postoperative thoracic surgery; discharge decision; thoracic ultrasound; pleural drain removal; chest X-ray; thoracic surgery monitoring

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Pain du to examination

  Day 0, Day 1 and At the study completion, an average of 10 days

• Subcutaneous emphysema

  Day 0, Day 1 and At the study completion, an average of 10 days

• Pneumothorax

  Day 0, Day 1 and At the study completion, an average of 10 days

• Pleural effusion

  Day 0, Day 1 and At the study completion, an average of 10 days

• Pulmonary Condensation

  Day 0, Day 1 and At the study completion, an average of 10 days

Study Arms (1)

All patients

EXPERIMENTAL

Procedure: Thoracic ultrasound versus chest X-ray

Interventions

Thoracic ultrasound versus chest X-ray PROCEDURE

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.

All patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Limoges: lead

Study Sites (1)

Limoges Univesity Hospital

Limoges, 87042, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2022
• First Posted: September 19, 2022
• Study Start: September 5, 2022
• Primary Completion: February 28, 2023
• Study Completion: February 28, 2023
• Last Updated: March 16, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)