Clinical trial NCT04438317: Thoracic Drains in Intensive Care Units: Comparison of Seldinger and Surgical Methods
Official title: Thoracic Drains in Intensive Care Units. Comparison of Seldinger and Surgical Methods: A Prospective Randomized Multicenter Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pleural Effusion
Pneumothorax
Hemothorax
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
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2020-06-18
Enrollment: 227
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: * Prospective clinical trial, randomized, controlled, open-label
* Two parallel groups, comparing two strategy involving different medical devices
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Composite criteria of major and minor complications related to chest drainage
timeFrame: ICU discharge up to 6 months
Secondary outcomes:
measure: Sedation and analgesia doses
timeFrame: Before, during, immediately after the procedure, every day until the removal of the chest tube, immediately after ICU discharge, Day 28 and Day 90
measure: Persistent residual pain: numerical pain scale
timeFrame: ICU discharge up to 6 months
measure: Evaluation of pain type
timeFrame: Before, during, immediately after the procedure, every day until the removal of the chest tube, immediately after ICU discharge, Day 28 and Day 90
measure: Evaluation of Pain
timeFrame: Before, during, immediately after the procedure
measure: Procedural criteria
timeFrame: Immediately after the pleural drainage procedure
measure: Procedural criteria
timeFrame: Immediately after the pleural drainage procedure
measure: Procedural criteria
timeFrame: Immediately after the pleural drainage procedure
measure: Ultrasound use
timeFrame: Before, during and immediately after the pleural drainage procedure
measure: Ultrasound use
timeFrame: Before the pleural drainage procedure
measure: Ultrasound use
timeFrame: Immediately after the pleural drainage procedure
measure: Ultrasound use
timeFrame: Immediately after the pleural drainage procedure
measure: General characteristics
timeFrame: Immediately after the pleural drainage procedure
measure: General characteristics
timeFrame: Immediately after the pleural drainage procedure
measure: General characteristics
timeFrame: Immediately after the pleural drainage procedure
measure: General characteristics
timeFrame: Immediately after the pleural drainage procedure
measure: General characteristics
timeFrame: Immediately after the pleural drainage procedure
measure: General characteristics
timeFrame: Immediately after the pleural drainage procedure
measure: General characteristics
timeFrame: Immediately after the pleural drainage procedure
measure: General characteristics
timeFrame: Immediately after the pleural drainage procedure
measure: Doctor performing drainage
timeFrame: Immediately after the pleural drainage procedure
measure: General characteristics
timeFrame: Immediately after the pleural drainage procedure
measure: Complications' rates
timeFrame: During the pleural drainage procedure and ICU discharge up to 6 months
measure: Complications' rates
timeFrame: During the pleural drainage procedure and ICU discharge up to 6 months
measure: Complications' rates
timeFrame: During the pleural drainage procedure and ICU discharge up to 6 months
measure: Complications' rates
timeFrame: During the pleural drainage procedure and ICU discharge up to 6 months
measure: Complications' rates
timeFrame: During the pleural drainage procedure and ICU discharge up to 6 months
measure: Complications' rates
timeFrame: During the pleural drainage procedure and ICU discharge up to 6 months
measure: Complications' rates
timeFrame: During the pleural drainage procedure and ICU discharge up to 6 months
measure: Complications' rates
timeFrame: During the pleural drainage procedure and ICU discharge up to 6 months
measure: Complications' rates
timeFrame: During the pleural drainage procedure and ICU discharge up to 6 months
measure: Complications' rates
timeFrame: During the pleural drainage procedure and ICU discharge up to 6 months
measure: Patients outcomes
timeFrame: 6 months
measure: Patients outcomes
timeFrame: 6 months
measure: Patients outcomes
timeFrame: Day 28
measure: Patients outcomes
timeFrame: Day 28
measure: Patients outcomes
timeFrame: Day 28
measure: Patients outcomes
timeFrame: Day 90
measure: Patients outcomes
timeFrame: Day 90
measure: Patients outcomes
timeFrame: Day 90
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU
Study officials:
References: