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

Not Applicable

Completed

• Conditions: Pneumothorax; Pleural Effusion; Hemothorax

• Registration Number: NCT04438317
• Lead Sponsor: University Hospital, Clermont-Ferrand

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.

Study Timeline

• Study Start: 2020-05-29
• Study First Submitted: 2020-06-03
• Study First Submitted QC: 2020-06-16
• Study First Posted: 2020-06-18
• Status Verified: 2022-12
• Primary Completion: 2023-04-04
• Study Completion: 2023-06-28
• Last Update Submitted: 2023-11-16
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 227

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Patients outcomes	Day 90	Hospital mortality
Procedural criteria	Immediately after the pleural drainage procedure	Number of drainage technique changes (cross-over)
Doctor performing drainage	Immediately after the pleural drainage procedure	Characteristic's rate (senior or junior, prior experience with drainage technique)
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	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).
General characteristics	Immediately after the pleural drainage procedure	Rate of Off-hours drainage
Complications' rates	During the pleural drainage procedure and ICU discharge up to 6 months	Complications associated with drainages made on hold during the ICU stay
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
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
Ultrasound use	Immediately after the pleural drainage procedure	Control of the position of the drain

Trial Locations

Locations (1)

CHU; 🇫🇷 Clermont-Ferrand, France