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

Pleural Effusion Clinical Trial

— DrainICU  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04438317
• Other study ID #: DrainICU - RBHP 2019 GODET 2
• Status: Completed
• Phase: N/A
• Start date: May 29, 2020
• Est. completion date: June 28, 2023

Study information

• Verified date: December 2022
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 227
• Est. completion date: June 28, 2023
• Est. primary completion date: April 4, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hemothorax
• Pleural Effusion
• Pneumothorax

Intervention

Procedure:
• Pleural drainage procedure with Seldinger procedure
Pleural drainage using Seldinger technique.
• Pleural drainage procedure with surgical-like technique
Pleural drainage using Surgical-like technique.

Locations

Country	Name	City	State
France	CHU	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

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