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OpenTrials
Completed

NCT Number: NCT04438317

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU

Clermont-Ferrand, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pleural drainage procedure with Seldinger procedure

Procedure

Pleural drainage using Seldinger technique.

Pleural drainage procedure with surgical-like technique

Procedure

Pleural drainage using Surgical-like technique.

Primary outcomes

  1. Composite criteria of major and minor complications related to chest drainage

    Time frame: ICU discharge up to 6 months

    • 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).

Secondary outcomes

  1. Sedation and analgesia doses

    Time frame: 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

  2. Persistent residual pain: numerical pain scale

    Time frame: ICU discharge up to 6 months

    Evaluated by a numerical pain scale (VAS : 0 = No pain to 10 = Worst possible pain)

  3. Evaluation of pain type

    Time frame: 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

  4. Evaluation of Pain

    Time frame: 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).

  5. Procedural criteria

    Time frame: Immediately after the pleural drainage procedure

    Number of failures of the procedure

  6. Procedural criteria

    Time frame: Immediately after the pleural drainage procedure

    Number of second operator necessary

  7. Procedural criteria

    Time frame: Immediately after the pleural drainage procedure

    Number of drainage technique changes (cross-over)

  8. Ultrasound use

    Time frame: Before, during and immediately after the pleural drainage procedure

    Rate of procedure use by care-providers

  9. Ultrasound use

    Time frame: Before the pleural drainage procedure

    Volume to be drained according to published methods

  10. Ultrasound use

    Time frame: Immediately after the pleural drainage procedure

    Assessment of pleural fluid type according to published methods

  11. Ultrasound use

    Time frame: Immediately after the pleural drainage procedure

    Control of the position of the drain

  12. General characteristics

    Time frame: Immediately after the pleural drainage procedure

    Type of Indication of drainage

  13. General characteristics

    Time frame: Immediately after the pleural drainage procedure

    Diameter of drain used (millimeter)

  14. General characteristics

    Time frame: Immediately after the pleural drainage procedure

    Diameter and brand of drain used

  15. General characteristics

    Time frame: Immediately after the pleural drainage procedure

    Drainage duration

  16. General characteristics

    Time frame: Immediately after the pleural drainage procedure

    Drain hold time in place

  17. General characteristics

    Time frame: Immediately after the pleural drainage procedure

    Drain insertion site (safety triangle)

  18. General characteristics

    Time frame: Immediately after the pleural drainage procedure

    Use or not of probabilistic antibioprophylaxis

  19. General characteristics

    Time frame: Immediately after the pleural drainage procedure

    Number of differences between the result of the randomization and the doctor's choice in terms of drainage technique

  20. Doctor performing drainage

    Time frame: Immediately after the pleural drainage procedure

    Characteristic's rate (senior or junior, prior experience with drainage technique)

  21. General characteristics

    Time frame: Immediately after the pleural drainage procedure

    Rate of Off-hours drainage

  22. Complications' rates

    Time frame: During the pleural drainage procedure and ICU discharge up to 6 months

    Infections at the insertion site or of pleural cavity during the ICU stay

  23. Complications' rates

    Time frame: During the pleural drainage procedure and ICU discharge up to 6 months

    Post-drainage pneumothorax during the ICU stay

  24. Complications' rates

    Time frame: During the pleural drainage procedure and ICU discharge up to 6 months

    Clogging of drain during the ICU stay

  25. Complications' rates

    Time frame: During the pleural drainage procedure and ICU discharge up to 6 months

    Drain Malposition during the ICU stay

  26. Complications' rates

    Time frame: During the pleural drainage procedure and ICU discharge up to 6 months

    Initiation of post-drainage mechanical ventilation if initially absent during the ICU stay

  27. Complications' rates

    Time frame: During the pleural drainage procedure and ICU discharge up to 6 months

    Per- and post-procedure bleeding during the ICU stay during the ICU stay

  28. Complications' rates

    Time frame: During the pleural drainage procedure and ICU discharge up to 6 months

    Intra- and post-drainage visceral lesions during the ICU stay

  29. Complications' rates

    Time frame: During the pleural drainage procedure and ICU discharge up to 6 months

    Fall of the drain during the stay during the ICU stay

  30. Complications' rates

    Time frame: During the pleural drainage procedure and ICU discharge up to 6 months

    Bad side or drainage site during the ICU stay

  31. Complications' rates

    Time frame: During the pleural drainage procedure and ICU discharge up to 6 months

    Complications associated with drainages made on hold during the ICU stay

  32. Patients outcomes

    Time frame: 6 months

    ICU mortality

  33. Patients outcomes

    Time frame: 6 months

    Hospital mortality

  34. Patients outcomes

    Time frame: Day 28

    ICU mortality

  35. Patients outcomes

    Time frame: Day 28

    Hospital mortality

  36. Patients outcomes

    Time frame: Day 28

    Days without mechanical ventilation

  37. Patients outcomes

    Time frame: Day 90

    Days without mechanical ventilation

  38. Patients outcomes

    Time frame: Day 90

    ICU mortality

  39. Patients outcomes

    Time frame: Day 90

    Hospital mortality

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Official study title

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

Acronym: DrainICU

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jun 18, 2020
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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