CHU
Clermont-Ferrand, France
NCT Number: NCT04438317
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Clermont-Ferrand, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Pleural drainage using Seldinger technique.
Pleural drainage using Surgical-like technique.
Time frame: ICU discharge up to 6 months
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
Time frame: ICU discharge up to 6 months
Evaluated by a numerical pain scale (VAS : 0 = No pain to 10 = Worst possible pain)
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
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).
Time frame: Immediately after the pleural drainage procedure
Number of failures of the procedure
Time frame: Immediately after the pleural drainage procedure
Number of second operator necessary
Time frame: Immediately after the pleural drainage procedure
Number of drainage technique changes (cross-over)
Time frame: Before, during and immediately after the pleural drainage procedure
Rate of procedure use by care-providers
Time frame: Before the pleural drainage procedure
Volume to be drained according to published methods
Time frame: Immediately after the pleural drainage procedure
Assessment of pleural fluid type according to published methods
Time frame: Immediately after the pleural drainage procedure
Control of the position of the drain
Time frame: Immediately after the pleural drainage procedure
Type of Indication of drainage
Time frame: Immediately after the pleural drainage procedure
Diameter of drain used (millimeter)
Time frame: Immediately after the pleural drainage procedure
Diameter and brand of drain used
Time frame: Immediately after the pleural drainage procedure
Drainage duration
Time frame: Immediately after the pleural drainage procedure
Drain hold time in place
Time frame: Immediately after the pleural drainage procedure
Drain insertion site (safety triangle)
Time frame: Immediately after the pleural drainage procedure
Use or not of probabilistic antibioprophylaxis
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
Time frame: Immediately after the pleural drainage procedure
Characteristic's rate (senior or junior, prior experience with drainage technique)
Time frame: Immediately after the pleural drainage procedure
Rate of Off-hours drainage
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
Time frame: During the pleural drainage procedure and ICU discharge up to 6 months
Post-drainage pneumothorax during the ICU stay
Time frame: During the pleural drainage procedure and ICU discharge up to 6 months
Clogging of drain during the ICU stay
Time frame: During the pleural drainage procedure and ICU discharge up to 6 months
Drain Malposition during the ICU stay
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
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
Time frame: During the pleural drainage procedure and ICU discharge up to 6 months
Intra- and post-drainage visceral lesions during the ICU stay
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
Time frame: During the pleural drainage procedure and ICU discharge up to 6 months
Bad side or drainage site during the ICU stay
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
Time frame: 6 months
ICU mortality
Time frame: 6 months
Hospital mortality
Time frame: Day 28
ICU mortality
Time frame: Day 28
Hospital mortality
Time frame: Day 28
Days without mechanical ventilation
Time frame: Day 90
Days without mechanical ventilation
Time frame: Day 90
ICU mortality
Time frame: Day 90
Hospital mortality
University Hospital, Clermont-Ferrand
Other
Thoracic Drains in Intensive Care Units. Comparison of Seldinger and Surgical Methods: A Prospective Randomized Multicenter Study
Acronym: DrainICU
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.
Published trials that share one or more normalized conditions with this study.
NCT06538376
Acute Copd Exacerbation, Acute Rejection of Lung Transplant (Disorder)
Boston, Massachusetts, United States
View Trial DetailsNCT05963945
Atelectasis, Cardiomegaly
Havířov, Czechia
View Trial DetailsNCT06075836
Atelectasis, Bronchial Diseases
Oxford, Oxfordshire, United Kingdom
View Trial DetailsNCT02808897
Arrhythmias, Cardiac, Atrial Fibrillation
Montreal, Quebec, Canada
View Trial Details