An interventional study of Pleural drainage procedure with Seldinger procedure and Pleural drainage procedure with surgical-like technique in Pleural Effusion, Pneumothorax and Hemothorax, sponsored by University Hospital, Clermont-Ferrand. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-18.
Sponsored by University Hospital, Clermont-Ferrand · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
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.
Procedure: Pleural drainage procedure with Seldinger procedure
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.
Procedure: Pleural drainage procedure with surgical-like technique
Pleural drainage using Seldinger technique.
Pleural drainage using Surgical-like technique.
Composite criteria of major and minor complications related to chest drainage
1. 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 2. 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).
Time frame: ICU discharge up to 6 months
Sedation and analgesia doses
Sedation and analgesia doses
Time frame: Before, during, immediately after the procedure, every day until the removal of the chest tube, immediately after ICU discharge, Day 28 and Day 90
Persistent residual pain: numerical pain scale
Evaluated by a numerical pain scale (VAS : 0 = No pain to 10 = Worst possible pain)
Time frame: ICU discharge up to 6 months
Evaluation of pain type
Type of pain neuropathic, nociceptive
Time frame: Before, during, immediately after the procedure, every day until the removal of the chest tube, immediately after ICU discharge, Day 28 and Day 90
Evaluation of Pain
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).
Time frame: Before, during, immediately after the procedure
Procedural criteria
Number of failures of the procedure
Time frame: Immediately after the pleural drainage procedure
Procedural criteria
Number of second operator necessary
Time frame: Immediately after the pleural drainage procedure
Procedural criteria
Number of drainage technique changes (cross-over)
Time frame: Immediately after the pleural drainage procedure
Ultrasound use
Rate of procedure use by care-providers
Time frame: Before, during and immediately after the pleural drainage procedure
Ultrasound use
Volume to be drained according to published methods
Time frame: Before the pleural drainage procedure
Ultrasound use
Assessment of pleural fluid type according to published methods
Time frame: Immediately after the pleural drainage procedure
Ultrasound use
Control of the position of the drain
Time frame: Immediately after the pleural drainage procedure
General characteristics
Type of Indication of drainage
Time frame: Immediately after the pleural drainage procedure
General characteristics
Diameter of drain used (millimeter)
Time frame: Immediately after the pleural drainage procedure
General characteristics
Diameter and brand of drain used
Time frame: Immediately after the pleural drainage procedure
General characteristics
Drainage duration
Time frame: Immediately after the pleural drainage procedure
General characteristics
Drain hold time in place
Time frame: Immediately after the pleural drainage procedure
General characteristics
Drain insertion site (safety triangle)
Time frame: Immediately after the pleural drainage procedure
General characteristics
Use or not of probabilistic antibioprophylaxis
Time frame: Immediately after the pleural drainage procedure
General characteristics
Number of differences between the result of the randomization and the doctor's choice in terms of drainage technique
Time frame: Immediately after the pleural drainage procedure
Doctor performing drainage
Characteristic's rate (senior or junior, prior experience with drainage technique)
Time frame: Immediately after the pleural drainage procedure
General characteristics
Rate of Off-hours drainage
Time frame: Immediately after the pleural drainage procedure
Complications' rates
Infections at the insertion site or of pleural cavity during the ICU stay
Time frame: During the pleural drainage procedure and ICU discharge up to 6 months
Complications' rates
Post-drainage pneumothorax during the ICU stay
Time frame: During the pleural drainage procedure and ICU discharge up to 6 months
Complications' rates
Clogging of drain during the ICU stay
Time frame: During the pleural drainage procedure and ICU discharge up to 6 months
Complications' rates
Drain Malposition during the ICU stay
Time frame: During the pleural drainage procedure and ICU discharge up to 6 months
Complications' rates
Initiation of post-drainage mechanical ventilation if initially absent during the ICU stay
Time frame: During the pleural drainage procedure and ICU discharge up to 6 months
Complications' rates
Per- and post-procedure bleeding during the ICU stay during the ICU stay
Time frame: During the pleural drainage procedure and ICU discharge up to 6 months
Complications' rates
Intra- and post-drainage visceral lesions during the ICU stay
Time frame: During the pleural drainage procedure and ICU discharge up to 6 months
Complications' rates
Fall of the drain during the stay during the ICU stay
Time frame: During the pleural drainage procedure and ICU discharge up to 6 months
Complications' rates
Bad side or drainage site during the ICU stay
Time frame: During the pleural drainage procedure and ICU discharge up to 6 months
Complications' rates
Complications associated with drainages made on hold during the ICU stay
Time frame: During the pleural drainage procedure and ICU discharge up to 6 months
Patients outcomes
ICU mortality
Time frame: 6 months
Patients outcomes
Hospital mortality
Time frame: 6 months
Patients outcomes
ICU mortality
Time frame: Day 28
Patients outcomes
Hospital mortality
Time frame: Day 28
Patients outcomes
Days without mechanical ventilation
Time frame: Day 28
Patients outcomes
Days without mechanical ventilation
Time frame: Day 90
Patients outcomes
ICU mortality
Time frame: Day 90
Patients outcomes
Hospital mortality
Time frame: Day 90
Plan to share: Undecided
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University Hospital, Clermont-Ferrand