Thoracic Drains in Intensive Care Units: Comparison of Seldinger and Surgical Methods

NCT ID: NCT04438317

Last Updated: 2023-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 227 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-29
• Study Completion Date: 2023-06-28

Brief Summary

This prospective randomized multicenter study is intended to investigate tolerance and effectiveness of thoracic drainage conducted by Seldinger technique with small drains, or by a surgical-like technique with large armed drains, in intensive care units patients.

Detailed Description

Drainage of pleural effusion and pneumothorax is a common feature in Resuscitation, Intensive Care Units (ICU) and Continuing Care Units (CCU). Although they are associated with a low incidence of complications (ranging from 0 to 8%), some of these can become fatal if they are associated with a visceral puncture (liver, spleen, lung parenchyma or heart by instance). It has been reported in the literature that complications were greater in case of drainage with large diameter drains set up by so-called "surgical-like" technique.

The choice of the type of chest tube is usually guided by the indication of drainage or the habits and / or experience of the practitioner. In the case of liquid pleural effusions, it may be preferable to use small diameter drains, whereas in the case of suspicious thick effusions such as empyema or blood, it may be preferable to use drainage drains of a larger diameter. However, results of retrospective analyzes seem to suggest the versatile and effective use of small-bore chest tubes in any of these indications without increasing complications' rates such as clogging.

However, no prospective randomized controlled trial (RCT) has studied this issue to date. Therefore, the investigators propose to perform a multicenter RCT in ICU and CCU patients requiring pleural drainage for any indication or underlying disease.

This prospective RCT is intended to investigate tolerance and effectiveness of thoracic drainage conducted by Seldinger technique with small drains, or by a surgical-like technique with large armed drains. Furthermore, they want to estimate the respective costs, identify the difficulties related to both strategies, recognize associated practices (ultrasound-guidance, implantation site, operator's competence), and finally point out the secondary determinants of tolerance and effectiveness.

Conditions

Pleural Effusion; Pneumothorax; Hemothorax

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Seldinger Technique

Small bore chest tubes inserted by Seldinger technique. A needle is inserted into the intercostal space, and the aspiration of a fluid allows the confirmation the correct position, possibly after ultrasound tracking. A metal guidewire is inserted through the needle, which is then removed. A dilator is then inserted on the metal guidewire to dilate the skin and the subcutaneous tissues. The chest tube is finally inserted on the guide, which is finally removed, and the chest tube is connected to the aspiration system after fixation to the chest wall.

Group Type: ACTIVE_COMPARATOR

Pleural drainage procedure with Seldinger procedure

Intervention Type: PROCEDURE

Pleural drainage using Seldinger technique.

Surgical-like Technique

Large bore chest tube inserted by surgical-like technique. Progressive chest wall dissection is conducted with appropriate instruments (scissors, scalpel, clamps…) by a non-surgeon physician. Large bore drain with rigid introductor is blindly inserted in the pleural cavity, secured to the chest wall with suture fixation and further connection to the aspiration system.

Group Type: ACTIVE_COMPARATOR

Pleural drainage procedure with surgical-like technique

Intervention Type: PROCEDURE

Pleural drainage using Surgical-like technique.

Interventions

Pleural drainage procedure with Seldinger procedure

Pleural drainage using Seldinger technique.

Intervention Type: PROCEDURE

Pleural drainage procedure with surgical-like technique

Pleural drainage using Surgical-like technique.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Of-age patient (>18years)
• Patient admitted in ICU or CCU
• Patient requiring a pleural drainage, semi-urgent or planned
• Patient with a social security insurance

Exclusion Criteria

• Patient under guardianship
• Severe or uncompensated bleeding disorders
• Thoracic trauma at the acute phase (<6 hours)
• Compressive pneumothorax requiring immediate and urgent needle exsufflation
• No thoracic drainage (whatever the technique used) performed previously during the same stay in ICU or CCU.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU

Clermont-Ferrand, , France

Countries

France

Other Identifiers

DrainICU - RBHP 2019 GODET 2

Identifier Type: -

Identifier Source: org_study_id