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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pleural Effusion, Pneumothorax, Hemothorax

Intervention / Treatment
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* Procedure: Pleural drainage procedure with Seldinger procedure
* Procedure: Pleural drainage procedure with surgical-like technique


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective clinical trial, randomized, controlled, open-label Two parallel groups, comparing two strategy involving different medical devices
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Seldinger Technique<br>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<br>* Pleural drainage using Seldinger technique.<br>|
| Active Comparator: Surgical-like Technique<br>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<br>* Pleural drainage using Surgical-like technique.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite criteria of major and minor complications related to chest drainage | 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). | ICU discharge up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sedation and analgesia doses | Sedation and analgesia doses | 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) | ICU discharge up to 6 months | 
| Evaluation of pain type | Type of pain neuropathic, nociceptive | 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). | Before, during, immediately after the procedure | 
| Procedural criteria | Number of failures of the procedure | Immediately after the pleural drainage procedure | 
| Procedural criteria | Number of second operator necessary | Immediately after the pleural drainage procedure | 
| Procedural criteria | Number of drainage technique changes (cross-over) | Immediately after the pleural drainage procedure | 
| Ultrasound use | Rate of procedure use by care-providers | Before, during and immediately after the pleural drainage procedure | 
| Ultrasound use | Volume to be drained according to published methods | Before the pleural drainage procedure | 
| Ultrasound use | Assessment of pleural fluid type according to published methods | Immediately after the pleural drainage procedure | 
| Ultrasound use | Control of the position of the drain | Immediately after the pleural drainage procedure | 
| General characteristics | Type of Indication of drainage | Immediately after the pleural drainage procedure | 
| General characteristics | Diameter of drain used (millimeter) | Immediately after the pleural drainage procedure | 
| General characteristics | Diameter and brand of drain used | Immediately after the pleural drainage procedure | 
| General characteristics | Drainage duration | Immediately after the pleural drainage procedure | 
| General characteristics | Drain hold time in place | Immediately after the pleural drainage procedure | 
| General characteristics | Drain insertion site (safety triangle) | Immediately after the pleural drainage procedure | 
| General characteristics | Use or not of probabilistic antibioprophylaxis | 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 | Immediately after the pleural drainage procedure | 
| Doctor performing drainage | Characteristic's rate (senior or junior, prior experience with drainage technique) | Immediately after the pleural drainage procedure | 
| General characteristics | Rate of Off-hours drainage | Immediately after the pleural drainage procedure | 
| Complications' rates | Infections at the insertion site or of pleural cavity during the ICU stay | During the pleural drainage procedure and ICU discharge up to 6 months | 
| Complications' rates | Post-drainage pneumothorax during the ICU stay | During the pleural drainage procedure and ICU discharge up to 6 months | 
| Complications' rates | Clogging of drain during the ICU stay | During the pleural drainage procedure and ICU discharge up to 6 months | 
| Complications' rates | Drain Malposition during the ICU stay | 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 | 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 | During the pleural drainage procedure and ICU discharge up to 6 months | 
| Complications' rates | Intra- and post-drainage visceral lesions during the ICU stay | 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 | During the pleural drainage procedure and ICU discharge up to 6 months | 
| Complications' rates | Bad side or drainage site during the ICU stay | 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 | During the pleural drainage procedure and ICU discharge up to 6 months | 
| Patients outcomes | ICU mortality | 6 months | 
| Patients outcomes | Hospital mortality | 6 months | 
| Patients outcomes | ICU mortality | Day 28 | 
| Patients outcomes | Hospital mortality | Day 28 | 
| Patients outcomes | Days without mechanical ventilation | Day 28 | 
| Patients outcomes | Days without mechanical ventilation | Day 90 | 
| Patients outcomes | ICU mortality | Day 90 | 
| Patients outcomes | Hospital mortality | Day 90 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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