<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04438317</url>
  </required_header>
  <id_info>
    <org_study_id>DrainICU - RBHP 2019 GODET 2</org_study_id>
    <nct_id>NCT04438317</nct_id>
  </id_info>
  <brief_title>Thoracic Drains in Intensive Care Units: Comparison of Seldinger and Surgical Methods</brief_title>
  <acronym>DrainICU</acronym>
  <official_title>Thoracic Drains in Intensive Care Units. Comparison of Seldinger and Surgical Methods: A Prospective Randomized Multicenter Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Clermont-Ferrand</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Clermont-Ferrand</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This prospective randomized multicenter study is intended to investigate tolerance and&#xD;
      effectiveness of thoracic drainage conducted by Seldinger technique with small drains, or by&#xD;
      a surgical-like technique with large armed drains, in intensive care units patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Drainage of pleural effusion and pneumothorax is a common feature in Resuscitation, Intensive&#xD;
      Care Units (ICU) and Continuing Care Units (CCU). Although they are associated with a low&#xD;
      incidence of complications (ranging from 0 to 8%), some of these can become fatal if they are&#xD;
      associated with a visceral puncture (liver, spleen, lung parenchyma or heart by instance). It&#xD;
      has been reported in the literature that complications were greater in case of drainage with&#xD;
      large diameter drains set up by so-called &quot;surgical-like&quot; technique.&#xD;
&#xD;
      The choice of the type of chest tube is usually guided by the indication of drainage or the&#xD;
      habits and / or experience of the practitioner. In the case of liquid pleural effusions, it&#xD;
      may be preferable to use small diameter drains, whereas in the case of suspicious thick&#xD;
      effusions such as empyema or blood, it may be preferable to use drainage drains of a larger&#xD;
      diameter. However, results of retrospective analyzes seem to suggest the versatile and&#xD;
      effective use of small-bore chest tubes in any of these indications without increasing&#xD;
      complications' rates such as clogging.&#xD;
&#xD;
      However, no prospective randomized controlled trial (RCT) has studied this issue to date.&#xD;
      Therefore, the investigators propose to perform a multicenter RCT in ICU and CCU patients&#xD;
      requiring pleural drainage for any indication or underlying disease.&#xD;
&#xD;
      This prospective RCT is intended to investigate tolerance and effectiveness of thoracic&#xD;
      drainage conducted by Seldinger technique with small drains, or by a surgical-like technique&#xD;
      with large armed drains. Furthermore, they want to estimate the respective costs, identify&#xD;
      the difficulties related to both strategies, recognize associated practices&#xD;
      (ultrasound-guidance, implantation site, operator's competence), and finally point out the&#xD;
      secondary determinants of tolerance and effectiveness.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 29, 2020</start_date>
  <completion_date type="Anticipated">February 28, 2024</completion_date>
  <primary_completion_date type="Anticipated">November 28, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Prospective clinical trial, randomized, controlled, open-label&#xD;
Two parallel groups, comparing two strategy involving different medical devices</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Since the study is based on two different techniques, the masking of participants, care providers and local investigator is impossible.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Composite criteria of major and minor complications related to chest drainage</measure>
    <time_frame>ICU discharge up to 6 months</time_frame>
    <description>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&#xD;
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).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sedation and analgesia doses</measure>
    <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</time_frame>
    <description>Sedation and analgesia doses</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Persistent residual pain: numerical pain scale</measure>
    <time_frame>ICU discharge up to 6 months</time_frame>
    <description>Evaluated by a numerical pain scale (VAS : 0 = No pain to 10 = Worst possible pain)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of pain type</measure>
    <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</time_frame>
    <description>Type of pain neuropathic, nociceptive</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of Pain</measure>
    <time_frame>Before, during, immediately after the procedure</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedural criteria</measure>
    <time_frame>Immediately after the pleural drainage procedure</time_frame>
    <description>Number of failures of the procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedural criteria</measure>
    <time_frame>Immediately after the pleural drainage procedure</time_frame>
    <description>Number of second operator necessary</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedural criteria</measure>
    <time_frame>Immediately after the pleural drainage procedure</time_frame>
    <description>Number of drainage technique changes (cross-over)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ultrasound use</measure>
    <time_frame>Before, during and immediately after the pleural drainage procedure</time_frame>
    <description>Rate of procedure use by care-providers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ultrasound use</measure>
    <time_frame>Before the pleural drainage procedure</time_frame>
    <description>Volume to be drained according to published methods</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ultrasound use</measure>
    <time_frame>Immediately after the pleural drainage procedure</time_frame>
    <description>Assessment of pleural fluid type according to published methods</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ultrasound use</measure>
    <time_frame>Immediately after the pleural drainage procedure</time_frame>
    <description>Control of the position of the drain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>General characteristics</measure>
    <time_frame>Immediately after the pleural drainage procedure</time_frame>
    <description>Type of Indication of drainage</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>General characteristics</measure>
    <time_frame>Immediately after the pleural drainage procedure</time_frame>
    <description>Diameter of drain used (millimeter)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>General characteristics</measure>
    <time_frame>Immediately after the pleural drainage procedure</time_frame>
    <description>Diameter and brand of drain used</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>General characteristics</measure>
    <time_frame>Immediately after the pleural drainage procedure</time_frame>
    <description>Drainage duration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>General characteristics</measure>
    <time_frame>Immediately after the pleural drainage procedure</time_frame>
    <description>Drain hold time in place</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>General characteristics</measure>
    <time_frame>Immediately after the pleural drainage procedure</time_frame>
    <description>Drain insertion site (safety triangle)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>General characteristics</measure>
    <time_frame>Immediately after the pleural drainage procedure</time_frame>
    <description>Use or not of probabilistic antibioprophylaxis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>General characteristics</measure>
    <time_frame>Immediately after the pleural drainage procedure</time_frame>
    <description>Number of differences between the result of the randomization and the doctor's choice in terms of drainage technique</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Doctor performing drainage</measure>
    <time_frame>Immediately after the pleural drainage procedure</time_frame>
    <description>Characteristic's rate (senior or junior, prior experience with drainage technique)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>General characteristics</measure>
    <time_frame>Immediately after the pleural drainage procedure</time_frame>
    <description>Rate of Off-hours drainage</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications' rates</measure>
    <time_frame>During the pleural drainage procedure and ICU discharge up to 6 months</time_frame>
    <description>Infections at the insertion site or of pleural cavity during the ICU stay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications' rates</measure>
    <time_frame>During the pleural drainage procedure and ICU discharge up to 6 months</time_frame>
    <description>Post-drainage pneumothorax during the ICU stay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications' rates</measure>
    <time_frame>During the pleural drainage procedure and ICU discharge up to 6 months</time_frame>
    <description>Clogging of drain during the ICU stay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications' rates</measure>
    <time_frame>During the pleural drainage procedure and ICU discharge up to 6 months</time_frame>
    <description>Drain Malposition during the ICU stay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications' rates</measure>
    <time_frame>During the pleural drainage procedure and ICU discharge up to 6 months</time_frame>
    <description>Initiation of post-drainage mechanical ventilation if initially absent during the ICU stay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications' rates</measure>
    <time_frame>During the pleural drainage procedure and ICU discharge up to 6 months</time_frame>
    <description>Per- and post-procedure bleeding during the ICU stay during the ICU stay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications' rates</measure>
    <time_frame>During the pleural drainage procedure and ICU discharge up to 6 months</time_frame>
    <description>Intra- and post-drainage visceral lesions during the ICU stay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications' rates</measure>
    <time_frame>During the pleural drainage procedure and ICU discharge up to 6 months</time_frame>
    <description>Fall of the drain during the stay during the ICU stay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications' rates</measure>
    <time_frame>During the pleural drainage procedure and ICU discharge up to 6 months</time_frame>
    <description>Bad side or drainage site during the ICU stay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications' rates</measure>
    <time_frame>During the pleural drainage procedure and ICU discharge up to 6 months</time_frame>
    <description>Complications associated with drainages made on hold during the ICU stay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patients outcomes</measure>
    <time_frame>6 months</time_frame>
    <description>ICU mortality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patients outcomes</measure>
    <time_frame>6 months</time_frame>
    <description>Hospital mortality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patients outcomes</measure>
    <time_frame>Day 28</time_frame>
    <description>ICU mortality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patients outcomes</measure>
    <time_frame>Day 28</time_frame>
    <description>Hospital mortality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patients outcomes</measure>
    <time_frame>Day 28</time_frame>
    <description>Days without mechanical ventilation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patients outcomes</measure>
    <time_frame>Day 90</time_frame>
    <description>Days without mechanical ventilation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patients outcomes</measure>
    <time_frame>Day 90</time_frame>
    <description>ICU mortality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patients outcomes</measure>
    <time_frame>Day 90</time_frame>
    <description>Hospital mortality</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1020</enrollment>
  <condition>Pleural Effusion</condition>
  <condition>Pneumothorax</condition>
  <condition>Hemothorax</condition>
  <arm_group>
    <arm_group_label>Seldinger Technique</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Surgical-like Technique</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Pleural drainage procedure with Seldinger procedure</intervention_name>
    <description>Pleural drainage using Seldinger technique.</description>
    <arm_group_label>Seldinger Technique</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Pleural drainage procedure with surgical-like technique</intervention_name>
    <description>Pleural drainage using Surgical-like technique.</description>
    <arm_group_label>Surgical-like Technique</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Of-age patient (&gt;18years)&#xD;
&#xD;
          -  Patient admitted in ICU or CCU&#xD;
&#xD;
          -  Patient requiring a pleural drainage, semi-urgent or planned&#xD;
&#xD;
          -  Patient with a social security insurance&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient under guardianship&#xD;
&#xD;
          -  Severe or uncompensated bleeding disorders&#xD;
&#xD;
          -  Thoracic trauma at the acute phase (&lt;6 hours)&#xD;
&#xD;
          -  Compressive pneumothorax requiring immediate and urgent needle exsufflation&#xD;
&#xD;
          -  No thoracic drainage (whatever the technique used) performed previously during the&#xD;
             same stay in ICU or CCU.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>l Laclautre</last_name>
    <phone>+33 4 73 754963</phone>
    <email>promo_interne_drci@chu-clermontferrand.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Thomas Godet</last_name>
    <email>tgodet@chu-clermontferrand.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>CHU</name>
      <address>
        <city>Clermont-Ferrand</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Thomas Godet</last_name>
    </contact>
    <investigator>
      <last_name>Benjamin Rieu</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Russell Chabanne</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Martin Charvin</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>June 3, 2020</study_first_submitted>
  <study_first_submitted_qc>June 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>December 22, 2022</last_update_submitted>
  <last_update_submitted_qc>December 22, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 23, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pleural effusion</keyword>
  <keyword>Pneumothorax</keyword>
  <keyword>Hemothorax</keyword>
  <keyword>Intensive Care Unit</keyword>
  <keyword>Seldinger</keyword>
  <keyword>Drain</keyword>
  <keyword>Chest drainage</keyword>
  <keyword>Complications</keyword>
  <keyword>Comparison of chest drainage techniques in ICU patients</keyword>
  <keyword>Small drain inserted by Seldinger technique</keyword>
  <keyword>Large drains inserted by surgical-like technique</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pleural Effusion</mesh_term>
    <mesh_term>Pneumothorax</mesh_term>
    <mesh_term>Hemothorax</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04438317
org study id: DrainICU - RBHP 2019 GODET 2
nct id: NCT04438317
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Prospective clinical trial, randomized, controlled, open-label
Two parallel groups, comparing two strategy involving different medical devices
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Since the study is based on two different techniques, the masking of participants, care providers and local investigator is impossible.
measure: Composite criteria of major and minor complications related to chest drainage
time frame: ICU discharge up to 6 months
description: 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).
measure: 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
description: Sedation and analgesia doses
measure: Persistent residual pain: numerical pain scale
time frame: ICU discharge up to 6 months
description: Evaluated by a numerical pain scale (VAS : 0 = No pain to 10 = Worst possible pain)
measure: 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
description: Type of pain neuropathic, nociceptive
measure: Evaluation of Pain
time frame: Before, during, immediately after the procedure
description: 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).
measure: Procedural criteria
time frame: Immediately after the pleural drainage procedure
description: Number of failures of the procedure
measure: Procedural criteria
time frame: Immediately after the pleural drainage procedure
description: Number of second operator necessary
measure: Procedural criteria
time frame: Immediately after the pleural drainage procedure
description: Number of drainage technique changes (cross-over)
measure: Ultrasound use
time frame: Before, during and immediately after the pleural drainage procedure
description: Rate of procedure use by care-providers
measure: Ultrasound use
time frame: Before the pleural drainage procedure
description: Volume to be drained according to published methods
measure: Ultrasound use
time frame: Immediately after the pleural drainage procedure
description: Assessment of pleural fluid type according to published methods
measure: Ultrasound use
time frame: Immediately after the pleural drainage procedure
description: Control of the position of the drain
measure: General characteristics
time frame: Immediately after the pleural drainage procedure
description: Type of Indication of drainage
measure: General characteristics
time frame: Immediately after the pleural drainage procedure
description: Diameter of drain used (millimeter)
measure: General characteristics
time frame: Immediately after the pleural drainage procedure
description: Diameter and brand of drain used
measure: General characteristics
time frame: Immediately after the pleural drainage procedure
description: Drainage duration
measure: General characteristics
time frame: Immediately after the pleural drainage procedure
description: Drain hold time in place
measure: General characteristics
time frame: Immediately after the pleural drainage procedure
description: Drain insertion site (safety triangle)
measure: General characteristics
time frame: Immediately after the pleural drainage procedure
description: Use or not of probabilistic antibioprophylaxis
measure: General characteristics
time frame: Immediately after the pleural drainage procedure
description: Number of differences between the result of the randomization and the doctor's choice in terms of drainage technique
measure: Doctor performing drainage
time frame: Immediately after the pleural drainage procedure
description: Characteristic's rate (senior or junior, prior experience with drainage technique)
measure: General characteristics
time frame: Immediately after the pleural drainage procedure
description: Rate of Off-hours drainage
measure: Complications' rates
time frame: During the pleural drainage procedure and ICU discharge up to 6 months
description: Infections at the insertion site or of pleural cavity during the ICU stay
measure: Complications' rates
time frame: During the pleural drainage procedure and ICU discharge up to 6 months
description: Post-drainage pneumothorax during the ICU stay
measure: Complications' rates
time frame: During the pleural drainage procedure and ICU discharge up to 6 months
description: Clogging of drain during the ICU stay
measure: Complications' rates
time frame: During the pleural drainage procedure and ICU discharge up to 6 months
description: Drain Malposition during the ICU stay
measure: Complications' rates
time frame: During the pleural drainage procedure and ICU discharge up to 6 months
description: Initiation of post-drainage mechanical ventilation if initially absent during the ICU stay
measure: Complications' rates
time frame: During the pleural drainage procedure and ICU discharge up to 6 months
description: Per- and post-procedure bleeding during the ICU stay during the ICU stay
measure: Complications' rates
time frame: During the pleural drainage procedure and ICU discharge up to 6 months
description: Intra- and post-drainage visceral lesions during the ICU stay
measure: Complications' rates
time frame: During the pleural drainage procedure and ICU discharge up to 6 months
description: Fall of the drain during the stay during the ICU stay
measure: Complications' rates
time frame: During the pleural drainage procedure and ICU discharge up to 6 months
description: Bad side or drainage site during the ICU stay
measure: Complications' rates
time frame: During the pleural drainage procedure and ICU discharge up to 6 months
description: Complications associated with drainages made on hold during the ICU stay
measure: Patients outcomes
time frame: 6 months
description: ICU mortality
measure: Patients outcomes
time frame: 6 months
description: Hospital mortality
measure: Patients outcomes
time frame: Day 28
description: ICU mortality
measure: Patients outcomes
time frame: Day 28
description: Hospital mortality
measure: Patients outcomes
time frame: Day 28
description: Days without mechanical ventilation
measure: Patients outcomes
time frame: Day 90
description: Days without mechanical ventilation
measure: Patients outcomes
time frame: Day 90
description: ICU mortality
measure: Patients outcomes
time frame: Day 90
description: Hospital mortality
arm group label: Seldinger Technique
arm group type: Active Comparator
description: 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.
arm group label: Surgical-like Technique
arm group type: Active Comparator
description: 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.
intervention type: Procedure
intervention name: Pleural drainage procedure with Seldinger procedure
description: Pleural drainage using Seldinger technique.
arm group label: Seldinger Technique
intervention type: Procedure
intervention name: Pleural drainage procedure with surgical-like technique
description: Pleural drainage using Surgical-like technique.
arm group label: Surgical-like Technique
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: l Laclautre
phone: +33 4 73 754963
email: promo_interne_drci@chu-clermontferrand.fr
last name: Thomas Godet
email: tgodet@chu-clermontferrand.fr
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Pleural Effusion
mesh term: Pneumothorax
mesh term: Hemothorax
sharing ipd: Undecided