Pleural EffusionDrainICUNCT04438317
Thoracic Drains in Intensive Care Units: Comparison of Seldinger and Surgical Methods
A study testing Pleural drainage procedure with Seldinger procedure and Pleural drainage procedure with surgical-like technique in people with Pleural Effusion and Pneumothorax, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pleural Effusion, Pneumothorax, Hemothorax
- What is being tested?
- Pleural drainage procedure with Seldinger procedure and Pleural drainage procedure with surgical-like technique
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 227 participants
- Where
- 1 siteFrance
- Study dates
- 29 May 2020to 28 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pleural Effusion, Pneumothorax, Hemothorax
- Being tested
- Pleural drainage procedure with Seldinger procedure, Pleural drainage procedure with surgical-like technique
- 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
- Medical subject headings
- Pleural Effusion, Pneumothorax, Hemothorax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pleural drainage procedure with Seldinger procedureProcedure or surgery
Pleural drainage using Seldinger technique.
Pleural drainage procedure with surgical-like techniqueProcedure or surgery
Pleural drainage using Surgical-like technique.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Pleural drainage procedure with surgical-like technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: ICU discharge up to 6 months
Secondary outcomes (39)
Sedation and analgesia doses
Sedation and analgesia doses
Measured: 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)
Measured: ICU discharge up to 6 months
Evaluation of pain type
Type of pain neuropathic, nociceptive
Measured: 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).
Measured: Before, during, immediately after the procedure
Procedural criteria
Number of failures of the procedure
Measured: Immediately after the pleural drainage procedure
Procedural criteria
Number of second operator necessary
Measured: Immediately after the pleural drainage procedure
Procedural criteria
Number of drainage technique changes (cross-over)
Measured: Immediately after the pleural drainage procedure
Ultrasound use
Rate of procedure use by care-providers
Measured: Before, during and immediately after the pleural drainage procedure
Ultrasound use
Volume to be drained according to published methods
Measured: Before the pleural drainage procedure
Ultrasound use
Assessment of pleural fluid type according to published methods
Measured: Immediately after the pleural drainage procedure
Ultrasound use
Control of the position of the drain
Measured: Immediately after the pleural drainage procedure
General characteristics
Type of Indication of drainage
Measured: Immediately after the pleural drainage procedure
General characteristics
Diameter of drain used (millimeter)
Measured: Immediately after the pleural drainage procedure
General characteristics
Diameter and brand of drain used
Measured: Immediately after the pleural drainage procedure
General characteristics
Drainage duration
Measured: Immediately after the pleural drainage procedure
General characteristics
Drain hold time in place
Measured: Immediately after the pleural drainage procedure
General characteristics
Drain insertion site (safety triangle)
Measured: Immediately after the pleural drainage procedure
General characteristics
Use or not of probabilistic antibioprophylaxis
Measured: 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
Measured: Immediately after the pleural drainage procedure
Doctor performing drainage
Characteristic's rate (senior or junior, prior experience with drainage technique)
Measured: Immediately after the pleural drainage procedure
General characteristics
Rate of Off-hours drainage
Measured: Immediately after the pleural drainage procedure
Complications' rates
Infections at the insertion site or of pleural cavity during the ICU stay
Measured: During the pleural drainage procedure and ICU discharge up to 6 months
Complications' rates
Post-drainage pneumothorax during the ICU stay
Measured: During the pleural drainage procedure and ICU discharge up to 6 months
Complications' rates
Clogging of drain during the ICU stay
Measured: During the pleural drainage procedure and ICU discharge up to 6 months
Complications' rates
Drain Malposition during the ICU stay
Measured: 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
Measured: 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
Measured: During the pleural drainage procedure and ICU discharge up to 6 months
Complications' rates
Intra- and post-drainage visceral lesions during the ICU stay
Measured: 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
Measured: During the pleural drainage procedure and ICU discharge up to 6 months
Complications' rates
Bad side or drainage site during the ICU stay
Measured: 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
Measured: During the pleural drainage procedure and ICU discharge up to 6 months
Patients outcomes
ICU mortality
Measured: 6 months
Patients outcomes
Hospital mortality
Measured: 6 months
Patients outcomes
ICU mortality
Measured: Day 28
Patients outcomes
Hospital mortality
Measured: Day 28
Patients outcomes
Days without mechanical ventilation
Measured: Day 28
Patients outcomes
Days without mechanical ventilation
Measured: Day 90
Patients outcomes
ICU mortality
Measured: Day 90
Patients outcomes
Hospital mortality
Measured: Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
- Study start29 May 2020
- Primary completion4 Apr 2023
- Study completion28 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pleural EffusionStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- * Prospective clinical trial, randomized, controlled, open-label * Two parallel groups, comparing two strategy involving different medical devices
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 227 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04438317
- Sponsor's protocol ID
- DrainICU - RBHP 2019 GODET 2
- Acronym
- DrainICU
- Status last verified
- Dec 2022
- First submitted
- 3 Jun 2020
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thoracic Drains in Intensive Care Units. Comparison of Seldinger and Surgical Methods: A Prospective Randomized Multicenter Study
- ClinicalTrials.gov ID
- NCT04438317
- Acronym / sponsor ID
- DrainICU / DrainICU - RBHP 2019 GODET 2
- Conditions
- Pleural Effusion, Pneumothorax, Hemothorax
- Keywords
- Pleural effusion, Pneumothorax, Hemothorax, Intensive Care Unit, Seldinger, Drain, Chest drainage, Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 227 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 29 May 2020 (actual)
- Primary completion
- 4 Apr 2023 (actual)
- Study completion
- 28 Jun 2023 (actual)
- First posted
- 18 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- * Prospective clinical trial, randomized, controlled, open-label * Two parallel groups, comparing two strategy involving different medical devices
| Arm | Type | Receives |
|---|---|---|
| Seldinger Technique | Active comparator | Procedure: Pleural drainage procedure with Seldinger procedureSmall 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. |
| Surgical-like Technique | Active comparator | Procedure: Pleural drainage procedure with surgical-like techniqueLarge 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pleural drainage procedure with Seldinger procedurePleural drainage using Seldinger technique. | Procedure or surgery | Seldinger Technique |
| Pleural drainage procedure with surgical-like techniquePleural drainage using Surgical-like technique. | Procedure or surgery | Surgical-like Technique |
Primary outcome
Composite criteria of major and minor complications related to chest drainage
Time frame: 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).
39 secondary outcomes
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
Persistent residual pain: numerical pain scale
Time frame: ICU discharge up to 6 months
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
Evaluation of Pain
Time frame: Before, during, immediately after the procedure
Procedural criteria
Time frame: Immediately after the pleural drainage procedure
Procedural criteria
Time frame: Immediately after the pleural drainage procedure
Procedural criteria
Time frame: Immediately after the pleural drainage procedure
Ultrasound use
Time frame: Before, during and immediately after the pleural drainage procedure
Ultrasound use
Time frame: Before the pleural drainage procedure
Ultrasound use
Time frame: Immediately after the pleural drainage procedure
Ultrasound use
Time frame: Immediately after the pleural drainage procedure
General characteristics
Time frame: Immediately after the pleural drainage procedure
General characteristics
Time frame: Immediately after the pleural drainage procedure
General characteristics
Time frame: Immediately after the pleural drainage procedure
General characteristics
Time frame: Immediately after the pleural drainage procedure
General characteristics
Time frame: Immediately after the pleural drainage procedure
General characteristics
Time frame: Immediately after the pleural drainage procedure
General characteristics
Time frame: Immediately after the pleural drainage procedure
General characteristics
Time frame: Immediately after the pleural drainage procedure
Doctor performing drainage
Time frame: Immediately after the pleural drainage procedure
General characteristics
Time frame: Immediately after the pleural drainage procedure
Complications' rates
Time frame: During the pleural drainage procedure and ICU discharge up to 6 months
Complications' rates
Time frame: During the pleural drainage procedure and ICU discharge up to 6 months
Complications' rates
Time frame: During the pleural drainage procedure and ICU discharge up to 6 months
Complications' rates
Time frame: During the pleural drainage procedure and ICU discharge up to 6 months
Complications' rates
Time frame: During the pleural drainage procedure and ICU discharge up to 6 months
Complications' rates
Time frame: During the pleural drainage procedure and ICU discharge up to 6 months
Complications' rates
Time frame: During the pleural drainage procedure and ICU discharge up to 6 months
Complications' rates
Time frame: During the pleural drainage procedure and ICU discharge up to 6 months
Complications' rates
Time frame: During the pleural drainage procedure and ICU discharge up to 6 months
Complications' rates
Time frame: During the pleural drainage procedure and ICU discharge up to 6 months
Patients outcomes
Time frame: 6 months
Patients outcomes
Time frame: 6 months
Patients outcomes
Time frame: Day 28
Patients outcomes
Time frame: Day 28
Patients outcomes
Time frame: Day 28
Patients outcomes
Time frame: Day 90
Patients outcomes
Time frame: Day 90
Patients outcomes
Time frame: Day 90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pleural drainage procedure with Seldinger procedure and Pleural drainage procedure with surgical-like technique in people with Pleural Effusion and Pneumothorax, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite criteria of major and minor complications related to chest drainage (time frame: ICU discharge up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.