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

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

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.

Study Overview

• Status: Completed
• Conditions: Pneumothorax; Hemothorax; Pleural Effusion
• Intervention / Treatment: Procedure: Pleural drainage procedure with Seldinger procedure; Procedure: Pleural drainage procedure with surgical-like technique

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.

• Study Type: Interventional
• Enrollment (Actual): 227
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France
    • CHU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Seldinger Technique; 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; Pleural drainage using Seldinger technique.
Active Comparator: Surgical-like Technique; 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 Surgical-like technique.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Actual): May 29, 2020
• Primary Completion (Actual): April 4, 2023
• Study Completion (Actual): June 28, 2023

Study Registration Dates

• First Submitted: June 3, 2020
• First Submitted That Met QC Criteria: June 16, 2020
• First Posted (Actual): June 18, 2020

Study Record Updates

• Last Update Posted (Estimated): November 20, 2023
• Last Update Submitted That Met QC Criteria: November 16, 2023
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Intensive Care Unit; Complications; Pleural effusion; Pneumothorax; Hemothorax; Seldinger; Drain; Chest drainage; Comparison of chest drainage techniques in ICU patients; Small drain inserted by Seldinger technique; Large drains inserted by surgical-like technique
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Pleural Diseases; Hemorrhage; Pneumothorax; Hemothorax; Pleural Effusion
• Other Study ID Numbers: DrainICU - RBHP 2019 GODET 2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No