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

NCT04438317 | Completed DMC

• 1 other identifier: DrainICU - RBHP 2019 GODET 2
• Study Type: interventional
• Target: 227
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Composite criteria of major and minor complications related to chest drainage

  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).

  ICU discharge up to 6 months

Secondary Outcomes (39)

• 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

  ICU discharge up to 6 months

• 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

• Evaluation of Pain

  Before, during, immediately after the procedure

• Procedural criteria

  Immediately after the pleural drainage procedure

Study Arms (2)

Seldinger Technique

ACTIVE COMPARATOR

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

Surgical-like Technique

ACTIVE COMPARATOR

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

Interventions

Pleural drainage procedure with Seldinger procedure PROCEDURE

Pleural drainage using Seldinger technique.

Seldinger Technique

Pleural drainage procedure with surgical-like technique PROCEDURE

Pleural drainage using Surgical-like technique.

Surgical-like Technique

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU

Clermont-Ferrand, France

Location

MeSH Terms

Conditions

Pleural Effusion; Pneumothorax; Hemothorax

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Since the study is based on two different techniques, the masking of participants, care providers and local investigator is impossible.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: * Prospective clinical trial, randomized, controlled, open-label * Two parallel groups, comparing two strategy involving different medical devices

Study Record Dates

• First Submitted: June 3, 2020
• First Posted: June 18, 2020
• Study Start: May 29, 2020
• Primary Completion: April 4, 2023
• Study Completion: June 28, 2023
• Last Updated: November 18, 2023

Record last verified: 2022-12

Locations

FR (1)