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

Thoracic Drains in Intensive Care Units. Comparison of Seldinger and Surgical Methods: A Prospective Randomized Multicenter Study

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.

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.

Pleural effusion, Pneumothorax, Hemothorax, Intensive Care Unit, Seldinger, Drain, Chest drainage, Complications, Comparison of chest drainage techniques in ICU patients, Small drain inserted by Seldinger technique, Large drains inserted by surgical-like technique

Prospective clinical trial, randomized, controlled, open-label Two parallel groups, comparing two strategy involving different medical devices

Since the study is based on two different techniques, the masking of participants, care providers and local investigator is impossible.

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.

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.

a composite criterion for major complications: organic lesions (spleen, liver, lung, artery, vessel ..., calculated frequency 0.2-1.4%) and post-drainage empyema or infection at the site level insertion rate (calculated frequency 0.2-1.4%) (non-inferiority hypothesis) and a composite criterion on the other complications (malposition of the drain (calculated frequency of 0.6-6.5%), clogging of the drain (calculated frequency of 8.1-5.2%) or drain drop (calculated frequency 1-21%) (hypothesis of superiority).

Before, during, immediately after the procedure, every day until the removal of the chest tube, immediately after ICU discharge, Day 28 and Day 90

Before, during, immediately after the procedure, every day until the removal of the chest tube, immediately after ICU discharge, Day 28 and Day 90

Evaluated by a numerical pain scale (if the patient is unable to communicate), or the BPS-NI (behavioral pain scale non-intubated, if the patient is non-intubated and unable to communicate, 3 to 12), or the BPS (behavorial pain scale, if the patient is intubated and unable to communicate, 0 to 12).

Number of differences between the result of the randomization and the doctor's choice in terms of drainage technique

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.