Hemothorax, Pleural Effusion, Pneumothorax
Conditions
Keywords
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
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.
Interventions
PROCEDUREPleural drainage procedure with Seldinger procedure
Pleural drainage using Seldinger technique.
PROCEDUREPleural drainage procedure with surgical-like technique
Pleural drainage using Surgical-like technique.
Sponsors
University Hospital, Clermont-Ferrand
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Since the study is based on two different techniques, the masking of participants, care providers and local investigator is impossible.
Intervention model description
* Prospective clinical trial, randomized, controlled, open-label * Two parallel groups, comparing two strategy involving different medical devices
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite criteria of major and minor complications related to chest drainage | ICU discharge up to 6 months | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Persistent residual pain: numerical pain scale | ICU discharge up to 6 months | Evaluated by a numerical pain scale (VAS : 0 = No pain to 10 = Worst possible pain) |
| Evaluation of pain type | Before, during, immediately after the procedure, every day until the removal of the chest tube, immediately after ICU discharge, Day 28 and Day 90 | Type of pain neuropathic, nociceptive |
| Evaluation of Pain | Before, during, immediately after the procedure | 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). |
| Procedural criteria | Immediately after the pleural drainage procedure | Number of failures of the procedure |
| 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 | Sedation and analgesia doses |
| General characteristics | Immediately after the pleural drainage procedure | Type of Indication of drainage |
| Doctor performing drainage | Immediately after the pleural drainage procedure | Characteristic's rate (senior or junior, prior experience with drainage technique) |
| Complications' rates | During the pleural drainage procedure and ICU discharge up to 6 months | Infections at the insertion site or of pleural cavity during the ICU stay |
| Patients outcomes | 6 months | ICU mortality |
| Ultrasound use | Before, during and immediately after the pleural drainage procedure | Rate of procedure use by care-providers |
Countries
France
Outcome results
None listed